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Reconstructing Meaning with Others in Loss: A Feasibility Pilot Randomized Controlled Trial of a Bereavement Group ab
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de
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Christopher J. MacKinnon , Nathan Grant Smith , Melissa Henry , Evgenia Milman , Harvey g
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M. Chochinov , Annette Körner , Mel Berish , Amanda Jessica Farrace , Nikoleta Liarikos & S. Robin Cohen a
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Department of Oncology, McGill University, Montreal, Québec, Canada
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Balfour Mount Palliative Care Unit, McGill University Health Center, Montreal, Québec, Canada c
Department of Psychological, Health, and Learning Sciences, University of Houston, Houston, Texas, USA d
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Department of Oncology, Psychology, and Otolaryngology–Head and Neck Surgery, McGill University, Montreal, Québec, Canada e
Lady-Davis Institute for Medical Research and Segal Cancer Centre, Jewish General Hospital, Montreal, Québec, Canada f
Department of Educational & Counseling Psychology, McGill University, Montreal, Québec, Canada g
Community Health Sciences, and Family Medicine (Division of Palliative Care), University of Manitoba, Winnipeg, Manitoba, Canada h
Champlain Regional College, St-Lambert, Québec, Canada
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Palliative Care Research, Jewish General Hospital, Montreal, Québec, Canada
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Hope & Cope, Jewish General Hospital, Montreal, Québec, Canada
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Programs in Palliative Care, Departments of Oncology and Medicine, McGill University, Montreal, Québec, Canada Accepted author version posted online: 12 Feb 2015.Published online: 12 Feb 2015.
To cite this article: Christopher J. MacKinnon, Nathan Grant Smith, Melissa Henry, Evgenia Milman, Harvey M. Chochinov, Annette Körner, Mel Berish, Amanda Jessica Farrace, Nikoleta Liarikos & S. Robin Cohen (2015) Reconstructing Meaning with Others in Loss: A Feasibility Pilot Randomized Controlled Trial of a Bereavement Group, Death Studies, 39:7, 411-421, DOI: 10.1080/07481187.2014.958628 To link to this article: http://dx.doi.org/10.1080/07481187.2014.958628
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Death Studies, 39: 411–421, 2015 Copyright # Taylor & Francis Group, LLC ISSN: 0748-1187 print=1091-7683 online DOI: 10.1080/07481187.2014.958628
Reconstructing Meaning with Others in Loss: A Feasibility Pilot Randomized Controlled Trial of a Bereavement Group Christopher J. MacKinnon
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Department of Oncology, McGill University, Montreal, Que´bec, Canada and Balfour Mount Palliative Care Unit, McGill University Health Center, Montreal, Que´bec, Canada
Nathan Grant Smith Department of Psychological, Health, and Learning Sciences, University of Houston, Houston, Texas, USA
Melissa Henry Department of Oncology, Psychology, and Otolaryngology–Head and Neck Surgery, McGill University, Montreal, Que´bec, Canada and Lady-Davis Institute for Medical Research and Segal Cancer Centre, Jewish General Hospital, Montreal, Que´bec, Canada
Evgenia Milman Department of Educational & Counseling Psychology, McGill University, Montreal, Que´bec, Canada
Harvey M. Chochinov Community Health Sciences, and Family Medicine (Division of Palliative Care), University of Manitoba, Winnipeg, Manitoba, Canada
Annette Ko¨rner Department of Educational & Counseling Psychology, McGill University, Montreal, Que´bec, Canada
Mel Berish Champlain Regional College, St-Lambert, Que´bec, Canada
Amanda Jessica Farrace Palliative Care Research, Jewish General Hospital, Montreal, Que´bec, Canada
Nikoleta Liarikos Hope & Cope, Jewish General Hospital, Montreal, Que´bec, Canada
S. Robin Cohen Programs in Palliative Care, Departments of Oncology and Medicine, McGill University, Montreal, Que´bec, Canada and Lady Davis Institute, Montreal, Que´bec, Canada
Received 4 July 2013; accepted 13 August 2014. Address correspondence to Christopher J. MacKinnon, Balfour Mount Palliative Care Unit, McGill University Health Center, 1001 Boulevard De´carie, Montreal, Que´bec, Canada, H4A 3J1. E-mail: [email protected]
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More effective psychosocial interventions that target uncomplicated bereavement are needed for those actively seeking support. The objective of this study was to assess the feasibility of evaluating a unique meaning-based group counseling (MBGC) intervention with a randomized controlled trial (RCT) design. Twenty-six bereft individuals were randomly assigned to either MBGC or a control bereavement support group. Twenty participants (11 experimental, nine control) completed all aspects of the study including self-report measures at baseline, postintervention, and 3-month follow-up of meaning in life, anxiety, depression, and grief. Results support the feasibility of an RCT with MBGC.
Uncomplicated grief is characterized by significant distress that does not impair social, occupational, or daily functioning (Stroebe, Hansson, Stroebe, & Schut, 2001). Correspondingly, the meaning-making paradigm (Neimeyer & Sands, 2011) is a contemporary and perhaps potent framework to understand bereavement. Meaning-making in bereavement can involve a process of re-establishing psychological well-being through finding benefits and reconstructing one’s identity after a death, as well as making sense of one’s own responses to loss (MacKinnon, Milman, et al., 2013; Neimeyer & Anderson, 2002). Attempts to translate this knowledge into clinical practice are flourishing (Neimeyer, 2012c) with increasing empirical evidence (Park, 2010). However, the meaning-making approach does not yet extend into the general bereavement support group literature. As such, we developed meaning-based group counseling (MBGC) (MacKinnon, Smith, et al., 2013). In an initial study we conducted a preliminary test and subsequently revised MBGC to ensure feasibility of both the intervention and the questionnaire battery (MacKinnon et al., 2015). The current article reports the next stage in intervention development: the feasibility results of a pilot randomized controlled trial (RCT).
BACKGROUND Past reviews have suggested that interventions for uncomplicated grief were not beneficial in reducing future psychological distress (Genevro, Marshall, & Miller, 2004) and may impede grieving processes (Stroebe, Schut, & Stroebe, 2007). Conversely, others have argued that past studies have been severely hampered by methodological biases, suggesting that any definitive conclusions of uncomplicated bereavement interventions are premature (Larson & Hoyt, 2007). Interventions often fail to specify a theoretical framework or are guided with excessive theories, as well as rely on methods that fail to properly randomize participants, or have a control group (Forte, Hill, Pazder, & Feudtner, 2004). Methods of intervention testing also tend not to be well-described, use nonvalidated outcome measures, and lack explicit indications for success
(Schut et al., 2001). Studies also tend to have inconsistent inclusion criteria or fail to screen participants (Currier, Neimeyer, & Berman, 2008). Lastly, past studies have not encouraged self-selection (see Schut & Stroebe, 2005), which is important in helping those with uncomplicated bereavement. Our rationale in creating MBGC was to develop and test a distinctive group intervention for uncomplicated bereavement that addresses a previously unexplored topic, specifically the intersections between meaning making and bereavement group counseling. The goal of MBGC is to influence meaning making; in preparing this study we could not locate any published bereavement support group literature that targets meaning making. We hypothesized that a focus on meaning making, as well as attempts to attend to the aforementioned methodological concerns, might set the stage for improving the historically poor outcomes of uncomplicated grief interventions. The objective of this study was to ascertain the feasibility of a pilot RCT with MBGC, using a larger sample size than the initial testing (n ¼ 9, MacKinnon et al., 2015). Secondary objectives included (a) identifying further refinements to MBGC based on participant feedback; (b) assessing if the outcome measures remain acceptable to participants; (c) ascertaining if randomization is feasible and whether a sufficient number of participants completed data collection; and (d) deciding whether the results support proceeding with a full RCT. To address these objectives, the study adhered to a formative evaluation methodology specified in the Stage Model of Behavior Therapy Research (Rounsaville, Carroll, & Onken, 2001). Consistent with the goals of pilot studies (van Meijel, Gamel, van Swieten-Duijfjes, & Grypdonck, 2004), the research objectives did not include an assessment of statistically significant differences as the small sample size would likely overestimate any effects of the intervention (Lancaster, Dodd, & Williamson, 2004).
METHODS The study was approved by the Jewish General Hospital Research Ethics Committee. It was registered with ClinicalTrials.gov prior to recruitment. The study design
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was a two-arm (experimental [EXP] and control [CTRL]) by three-repeated-measures (pre, post, and follow-up) pilot RCT. Outcome measures were administered at three times: Time 1 (T1), within the 4 months prior to the start of the study across both arms (respective intervention [MBGC or CTRL]); Time 2 (T2), within 2 weeks of intervention completion; and Time 3 (T3), 3 months following intervention completion of the respective study arm. Failure to complete either the T2 or T3 measures resulted in the participant’s data being withdrawn from the descriptive statistical analyses. Feasibility and acceptability threshold criteria for claiming success were established a priori as such: (a) qualitative data indicated that individuals did not experience an overall detrimental effect from participating in MBGC; (b) there was no substantial attrition (i.e., dropouts resulted in less than four members in either treatment arm); and (c) the majority of participants completed all questionnaire batteries. Study Population, Recruitment, and Randomization Recruitment was in collaboration with a community organization associated with an urban university teaching hospital. The study was announced by posters displayed at various healthcare agencies. As this pilot study was not intended to identify significant differences, a sample size of 24–32 was selected (consistent with similar bereavement group studies; e.g., Hilliard, 2001, N ¼ 18). Individuals were eligible to participate in the study if they met the following criteria: (a) 18 years of age at the time of the first group session; (b) actively seeking support for themselves; (c) experiencing an uncomplicated grief trajectory (defined as grief occurring within 6 weeks to 2 years following the death);1 (d) and with an absence of grief symptoms (e.g., yearning, sadness, intrusive thoughts of the deceased, see Shear et al., 2011) that impaired daily functioning as reported by participants; (e) ability to speak and read in English; and (f) ability to function in a group following the selection recommendations of Yalom and Leszcz (2005). Candidates were excluded if they were (a) experiencing a prolonged grief response;2 (b) a parent grieving the death of a child under 18 years old; (c) grieving a suicide or homicide death; or (d) exhibiting personality traits counter-productive for a group (e.g., Axis II disorders on DSM-IV-TR).
1
This timeframe corresponds to the framework of common grief adaptation as described by both Prigerson and Maciejewski (2008b) as well as Davidson (1979) as reported by Neimeyer (2006). 2 Prolonged grief disorder is defined as a state that endures for at least 6 months and includes grief-related psychological distress that impairs functioning (Holland, Neimeyer, Boelen, & Prigerson, 2008).
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Candidates were invited to take part in a screening interview after giving written informed consent. They then completed a demographic form. Interviews ranged from 30 to 90 min depending on the level of psychological distress. Interviews were conducted by Christopher J. MacKinnon and, when possible, with Nikoleta Liarikos, each a facilitator in one of the study arms. The Psychosocial Assessment Elements (Keefler, 2005) interview guide was used to structure the interview and gauge current psychological functioning. The Prolonged Grief Disorder 13 (PG-13; Prigerson & Maciejewiski, 2008a) was used to inform a clinical profile of prolonged grief after 6 months.3 As the PG-13 remains in the early stages of empirical validation, final decision for inclusion or exclusion rested on the clinical judgment of the interviewers and not reliance on a cut-off score. Once deemed eligible, participants were randomized to the EXP or CTRL group in a 1:1 ratio. Block randomization prevented the researchers conducting the screening interviews from forecasting which arm participants would be randomized to. Randomization was accomplished using a random number generator (www.random.org) following CONSORT guidelines. The number of participants in each group ranged from six to eight, following standard support group size conventions (see Yalom & Leszcz, 2005). Experimental Condition MBGC for bereavement is an original and manualized intervention developed for adults experiencing uncomplicated grief (MacKinnon, Smith, et al., 2013). MBGC is comprised of various semistructured meaning-based tasks and themes embedded over 12 weekly sessions of 90 min (see Table 1). Two licensed mental health professionals co-facilitated all MBGC sessions. A research assistant (RA) was also present who functioned as an observer. Facilitators received training before delivery of MBGC from Christopher J. MacKinnon. Control Condition The CTRL arm was a treatment-as-usual bereavement support group. These CTRL support groups were part of a longstanding program conducted by the same community organization associated with recruitment. Group sessions took place biweekly with a total of seven 90-min sessions. The CTRL group followed more conventional bereavement support group themes, though assumed a relatively unstructured and atheoretical approach (see Table 2). The CTRL group (which has run for years)
3
The PG-13 is not designed to be given until six months after the death.
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C. J. MACKINNON ET AL. TABLE 1 Experimental Arm: Weekly Meaning-Based Group Counseling Session 1 2 3 4 5 6 7
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8 9 10 11 12
Tasks and themes Establishing norms; Exploring bereavement narratives Conventional bereavement group themes; members share meaningful objects associated with the deceased The Griefline Exercise; meaningful events Understandings and applications of the Theory of Shattered Assumptions (Janoff-Bulman, 1992) Understandings of the Dual Process Model (Stroebe & Schut, 1999) Sharing perceived changes in self and the family in the aftermath of loss Discussing the meaning of dreaming about the deceased (Hill, Zack, Wonnell, Hoffman, Rochlen, et al., 2000); Hello Again Letter (Neimeyer, 2012a) introduced Exploring member’s responses to the Hello Again Letter Identifying creative, attitudinal, and spiritual meaning sources (Breitbart, Rosenfeld, Gibson, Pessin, Poppito, et al., 2010); Life Imprints (Neimeyer, 2012b) introduced Exploring member’s responses to the Life Imprints Exploring the meaning of the group and its impending conclusion Gains made and future directions
has never had an explicit focus on meaning as reported by the CTRL facilitators. CTRL groups were each facilitated by two lay volunteers (nonprofessionals); in one group a licensed social worker acted as a third facilitator. Facilitators in the CTRL arm had received prior training in bereavement group facilitation through the community organization. Treatment Fidelity and Integrity For the EXP group, a treatment fidelity and integrity checklist (developed specifically for this study based on the components of MBGC) was completed every session by the RA and the two facilitators to ascertain adherence to the MBGC protocol. Comparison of each treatment fidelity checklist indicated that MBGC was delivered consistently with facilitators closely adhering to the intervention manual. The CTRL arm was not audited due to resource limitations. Masking Neither participants nor researchers were blind to treatment arm randomization. Although there was no reason to expect interaction between members of different
groups, in order to minimize cross-contamination participants were asked to only discuss the intervention with other members of their respective groups. Facilitators did not examine participants’ responses to the outcome questionnaires until after follow-up data were collected. Qualitative Data Sources To effect possible further refinements to MBGC and assess participants’ responses to MBGC, several qualitative data sources were accumulated in the EXP condition. Independent field notes were written by the cofacilitators for each session. Second, the RA completed a comprehensive observation protocol with the purpose of attending to group meaning-making processes. Third, participants in the EXP arm were encouraged to provide feedback on the intervention and suggest changes throughout. Lastly, the sample was assessed for use of professional psychosocial services, as well as any psychotropic medications begun, taken, or adjusted during the study. No formal qualitative methodology was used to analyze these data sources, but rather participant responses and comments were solicited to convey their impressions and recommendations for improving both the measures and interventions.
TABLE 2 Control Arm: Biweekly Conventional Bereavement Support Group Session 1 2 3 4 5 6 7
Themes and tasks Introductions; Norm setting Symptoms of grief: Grieving Person’s Bill of Rights Feelings associated with grief, funeral, and presence at time of death Coping and support; Finding and establishing a support network Bereavement related film with discussion OR: Motivational speaker (not related to bereavement) Memories: Sharing keepsakes AND=OR music therapy session Recovery; Personal strengths; Journaling
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FIGURE 1 Participant flow.
Quantitative Outcome Measures Four primary outcomes were chosen: grief, depression, anxiety, and meaning in life. The majority of outcome measures were selected due to their assessment of grief symptomatology and psychometric properties. A few measures were chosen for their strong face validity. The outcomes of anxiety and depression were assessed with one measure each. Three questionnaires were chosen for each of the grief and meaning outcomes as those questionnaires have few studies demonstrating their psychometric reliability and validity. Questionnaires that specify a timeframe (e.g., the severity of a grief
symptom within the past 2 weeks) are explicitly noted below as several scales do not assess time. The three grief measures were as follows. First, the Revised Grief Experience Inventory (RGEI; Lev, Munro, & McCorkle, 1993) is designed to measure the grief experience. Second, the Core Bereavement Items instrument (CBI; Burnett, Middleton, Raphael, & Martinek, 1997) assesses frequently experienced phenomena in the bereaved. Lastly, the Hogan Grief Reaction Checklist (HGRC; Hogan, Greenfield, & Schmidt, 2001) consists of a list of thoughts and emotions an individual may have experienced within the past two weeks related to the
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death of a significant loved one. There are six subscales: blame and anger, detachment, despair, disorganization, panic behavior, and personal growth. Depression was assessed with the Center for Epidemiologic Studies Depression Scale (Radloff, 1977); it assesses symptoms of clinical depression within the past week. Anxiety was assessed using both subscales of the State-Trait Anxiety Inventory: state (a temporary variation in emotionality) and trait (a comparatively stable feature) (Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983) Of the three measures selected for the outcome of meaning in life, two are reported here.4 The Purpose in Life Test (PIL; Crumbaugh & Maholick, 1964) evaluates Frankl’s theory of existential meaning. The Integration of Stressful Life Experiences Scale (ISLES; Holland, Currier, Coleman, & Neimeyer, 2010) is designed to gauge the degree to which an individual is able to adaptively integrate a stressful life event. Only descriptive statistics were calculated for the outcome measures. The percentage of scale range changes between T1 and T3 was calculated for each instrument. RESULTS Data collection took place over 17 months. Progress of participants from recruitment and screening through each phase of the study is shown in Figure 1 (EXP n ¼ 11; CTRL n ¼ 9). Nineteen of 45 potential participants were excluded (42%). Recruitment Rate Participants were recruited over a period of 4 months prior to the beginning of their respective group. The majority of participants included in the study were referred by allied mental health professionals (n ¼ 17, 65%). On average, 6.5 individuals (SD ¼ 4.93; Mdn ¼ 6) signed consent, completed baseline questionnaires and were randomized each month. On average, a participant in the EXP arm needed to wait 26 days (SD ¼ 26.85; Mdn ¼ 14.5) before their respective group began. Those in the CTRL group waited on average 50 days (SD ¼ 39.15; Mdn ¼ 51.5). Wait times had to do with logistics, specifically scheduling group leaders and participants, as well as reserving space to conduct the groups. Sample Characteristics and Attendance Demographic data are summarized in Table 3. Participants were predominantly female, heterosexual, 4
The Grief and Meaning Reconstruction Inventory (GMRI; Gillies, Neimeyer, & Milman, 2014) was also administered though the results are not reported.
TABLE 3 Baseline Sociodemographic Variables ( Sample Sizes Vary With Missing Data) Experimental (n ¼ 14) M (SD) 52.36 (19.18)
Control (n ¼ 12) M (SD) 45.00 (15.31)
Age n
%
Gender Female 12 85.71 Male 2 14.28 Ethnicity Caucasian 12 85.71 Arabic 1 7.14 Asian 1 7.14 Latino=a 0 0.00 Sexual orientation Heterosexual 14 100.00 Bisexual 0 0.00 Homosexual 0 0.00 Spiritual=religious orientation Christian 4 28.57 Jewish 5 35.71 Atheist= 3 21.43 Nonreligious Agnostic 1 7.14 Muslim 1 7.14 Education ( Exp n ¼ 12; Ctrl n ¼ 11) Bachelors Degree 7 58.33 Masters or above 3 25.00 Elementary 1 8.33 High School 1 8.33 Family income ( Exp n ¼ 12 ; Ctrl n ¼ 10) Less than $20,000 0 0.00 CAD $20,001 to $39,999 1 8.33 CAD $40,000 to $59,999 4 33.33 CAD $60,000 to $79,999 6 50.00 CAD More than 1 8.33 $80,000 CAD Civil status Widowed 6 42.86 Single 4 28.57 Married=common 2 14.29 law Partnered but 2 14.29 living alone Relationship being presently grieved Parent 5 35.71 Spouse 6 42.86 Friend 1 7.14 Sibling 1 7.14 Grandparent 1 7.14 Previous death-related losses 0 4 28.57 1 4 28.57 2 or more 6 42.86
n
%
10 2
83.33 16.67
10 0 0 1
83.33 0 0 8.33
10 2 0
83.33 16.67 0.00
9 1 1
75.00 8.33 8.33
1 0
8.33 0.00
6 3 1 1
54.54 27.27 9.09 9.09
1
10.00
2
20.00
2
20.00
2
20.00
3
30.00
4 4 3
33.33 33.33 25.00
1
8.33
6 4 1 1 0
50.00 33.33 8.33 8.33 0.00
5 4 3
41.67 33.33 16.67
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religiously identified as either Jewish or Christian, and of Caucasian ethnicity. The mean attendance in MBGC was 86%, corresponding to 10.3 out of 12 sessions (SD ¼ 0.95). Comparatively, those in the CTRL arm attended on average 74% (M ¼ 5.20, SD ¼ 0.79) of seven sessions available.
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Contamination No participant in the EXP arm reported discussing the study with anyone in the CTRL arm (and vice-versa). In addition, data were collected to assess external support participants sought during the study, as well as possible contamination across treatment arms. Missing data resulted in responses from only 18 participants (69%). Four participants (29%) in the EXP arm and one participant in the CTRL arm (10%) reported participation in concurrent individual psychotherapy. A minority of participants reported taking either anti-depressants or anxiolytics (EXP [n ¼ 4, 40%]; CTRL [n ¼ 1, 13%]). Descriptive Statistical Results Quantitative data were analyzed using SPSS version 19. Participants generally completed the entire questionnaire battery with six individuals (23%; two EXP, two CTRL) lost to attrition (see Figure 1). Table 4 contains means and standard deviations of the outcome measures at all
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three timepoints. A comparison of averages suggests that the EXP group on the whole had lower average meaning and higher depression at baseline compared to the CTRL group. Means across the anxiety and grief measures were similar across treatment arms at T1. Looking at trends across the three time periods, mean scores in the CTRL group improved at 2 weeks postintervention, though were often not maintained at 3-month follow-up (T3). Conversely, some measures in the EXP group showed moderate mean improvement at 2 weeks after the intervention that was either maintained or continued to improve 3 months postintervention. Figure 2 contains percentage of scale range changes between T1 and T3. Responses to MBGC There were no major refinements indicated to the intervention during this study. In addition, no participants reported withdrawing from the study due to increased psychological distress. Most participants (n ¼ 18, 90%) found the questionnaire battery acceptable (i.e., no consistent negative comments on items or scales). There were minimal missing data, with the maximum being 20% for two items. Some participants wrote comments in the margins of the measure, often adding contextual details. For example, some participants felt that their responses to the outcome measures were influenced by
TABLE 4 Descriptive Results
T1: Baseline Mean (SD) Measure (with range) RGEI (22–135) CBI (0–51) HGRCy Blame and anger (7–35) Despair (13–65) Detachment (8–40) Disorganization (7–35) Panic behavior (14–70) Personal growth (12–60) CES-D (0–60) STAI: State (20–80) STAI: Trait (20–80) PIL (15–105) ISLES (16–80)
EXP (n ¼ 11)
CTRL (n ¼ 9)
T2: 2 weeks post-intervention Mean (SD) EXP (n ¼ 11)
CTRL (n ¼ 9)
T3: 3 months post-intervention follow-up Mean (SD) EXP (n ¼ 11)
CTRL (n ¼ 9)
a
67.29 (17.55)a 24.33 (11.65)a
80.52 (12.43) 35.34 (8.73)
77.22 (22.66) 26.89 (11.87)
77.09 (16.30) 31.68 (10.45)
76.57 (20.79) 26.44 (12.42)
73.45 (13.68) 25.01 (10.90)a
14.48 34.92 15.91 15.64 33.73 38.91 23.93 48.01 43.43 70.45 45.00
13.33 33.67 16.89 16.44 32.00 33.89 17.89 49.43 46.49 77.33 49.51
11.55 29.36 14.60 13.55 26.56 34.64 18.55 41.84 41.73 75.05 50.93
13.67 30.67 18.56 17.56 37.11 35.67 14.89 44.56 43.00 78.78 52.89
11.27 27.27 12.27 12.47 24.45 34.91 14.09 40.45 39.82 76.18 52.34
(8.59) (14.37) (6.36) (4.32) (15.82) (14.65) (13.54) (14.77) (13.56) (20.90) (16.17)
(6.34) (15.40) (8.27) (6.88) (9.06) (11.12) (14.97) (12.05) (18.34) (12.92) (15.59)
(4.89) (12.49) (5.63) (4.48) (11.05) (11.72) (11.47) (14.69) (12.16) (11.30) (13.52)
(5.48) (13.00) (8.85) (8.09) (13.20) (9.29) (10.15) (6.77) (7.26) (7.55) (13.05)
(5.24)a (11.91)a (4.65)a (4.37)a (10.41)a (14.61)a (10.33)a (10.88)a (9.86)a (10.54)a (14.84)a
12.00 25.44 17.17 16.89 29.29 33.89 11.22 44.11 41.44 76.78 51.56
(4.56)a (8.26)a (5.88)b (7.61)b (9.92)a (8.89)c (8.54)a (5.90)a (8.66)a (11.81)b (14.24)a
Note: Parenthesized ranges beside the scale names refer to minimum and maximum scores. EXP ¼ experimental arm; CTRL ¼ control arm; PIL ¼ Purpose in Life Test; ISLES ¼ Integration of Stressful Life Experiences Scale; STAI ¼ State-Trait Anxiety Inventory; CES-D ¼ Center for Epidemiological Studies Depression Scale; RGEI ¼ Revised Grief Experiences Inventory; CBI ¼ Core Bereavement Items; HRGC ¼ Hogan Grief Reaction Checklist. y There is no total score for the Hogan Grief Reaction Checklist. Reversed score: Lower scores are indicative of greater personal growth. a Score improved from baseline. b Score declined from baseline. c No change in scores from baseline.
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FIGURE 2 Percentage of scale range changes. EXP ¼ experimental arm; CTRL ¼ control arm; PIL ¼ Purpose in Life Test; ISLES ¼ Integration of Stressful Life Experiences Scale; STAI ¼ State-Trait Anxiety Inventory; CES-D ¼ Center for Epidemiological Studies Depression Scale; RGEI ¼ Revised Grief Experiences Inventory; CBI ¼ Core Bereavement Items; HRGC ¼ Hogan Grief Reaction Checklist.
recent health problems. Furthermore, participant feedback suggested that there is a need to develop grief measures that are more time sensitive as many reported that their symptoms of distress fluctuated greatly over time. Specifically the PIL, ISLES, RGEI, and CBI fail to set a timeframe for their items. Some participants made requests to have more homogeneity in the group. The desire to want to ‘‘be with people like me’’ was a common sentiment expressed during screening and may relate to the desire for normalization and validation of one’s grief experience. Conversely, the benefits of encountering dissimilar grief experiences of an objectively similar event (e.g., loss of a spouse) were identified by some participants by the conclusion of MBGC as one of the principal gains from participating. Participants also reported benefits from the meaning-based underpinnings of MBGC. Participants reported making more sense of their own particular bereavement response. The meaning-based written exercises (e.g., Neimeyer, 2012a) emerged as particularly beneficial, bringing about new insights in constructing more adaptive and less concrete continuing bonds with the deceased through the process of sharing responses with others.
DISCUSSION When the threshold criteria for success are examined, the results appear to indicate that the pilot RCT of MBGC was feasible. First, no individuals in the EXP condition reported overall greater levels of psychological distress following participation. Second, there was no substantial attrition during intervention delivery or data collection. Third, approximately 75% of participants completed all the questionnaire batteries. Recruitment for the study was relatively seamless.
Referrals from allied health care professionals tended to yield the greatest number of eligible individuals who were subsequently included in the study. Individuals in both treatment arms largely attended and completed their respective groups. Strong attendance suggests that some individuals in uncomplicated bereavement desire a form of more formal support to facilitate coping. The outcome measures appeared to be acceptable to individuals, with no major negative comments. The mean scores at 3 months for MBGC participants showed no worsening from baseline. In addition, the averages of most outcomes improved more at 3-month follow-up in the EXP than in the CTRL condition. Furthermore, consistent with the objective of re-evaluating the choice of outcome measures used in this pilot study (Lancaster et al., 2004), more sensitive measures that assess both state as well as trait grief and meaning with specific time frames (e.g., ‘‘within the past 2 weeks’’ is a common convention) are desirable. Participants reported that they were largely satisfied with the tasks and themes of MBGC, as well as the order in which they were presented. Although some participants desired more homogeneity of grief experience during screening, accommodating these requests poses a major challenge in that attempting to recruit participants using narrow inclusion criteria jeopardizes feasibility. Whereas striking a perfect balance between homo- and heterogeneity is challenging, participant responses to MBGC suggest that having a more diverse membership (e.g., age range, gender, relationship to the deceased) may provide added benefits compared to a strictly homogeneous group composition (echoing Yalom & Leszcz, 2005; see MacKinnon et al., 2015). This pilot RCT attempted to address a number of previous critiques of past studies for uncomplicated grief. Attending to past design flaws may have facilitated some of the promising results reported in this pilot
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study. Nevertheless, this pilot revealed some flaws in our design as well, as specified below in the Limitations section. The discussion of limitations lays the foundation for further investigations.
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Limitations As is expected in a feasibility pilot study, no cause-andeffect outcomes can be concluded. In addition to any effect of MBGC, larger mean improvements in the EXP group than the CTRL group may be due to more concurrent individual psychotherapy as well as more use of prescribed psychotropic medications in the EXP group. Furthermore, those in the EXP arm may have had higher levels of psychological distress at baseline than CTRLs. Because the CTRL group started at lower levels of depression and higher levels of meaning, there may have been less space for improvement, whereas the larger improvements in the EXP arm may be in part due to regression towards the mean. Limited success was made in attempting to address previous critiques concerning problematic CTRL groups in bereavement intervention design (Schut & Stroebe, 2005). While some of the limitations of a treatment-asusual CTRL could have been predicted, in designing the study it was decided that there were sufficient benefits as this method permitted a partial appraisal of customary practices of interventions for uncomplicated grief that may be indicative of common norms in the field. This decision also resulted in several procedural dilemmas that curbed methodological rigor. Specifically, comparisons of the EXP and CTRL arms were confounded by greater absenteeism and attrition in the CTRL groups, and different frequencies and number of sessions in each treatment arm. The EXP condition provided almost double the number of sessions and may have created an imbalanced response in participants. Facilitation of each intervention was also confounded in that the EXP groups were consistently led by licensed mental health professionals whereas one CTRL group was led by trained volunteers with a social worker and another with only trained volunteers. Moreover, the tasks and themes in each of the two CTRL groups were inconsistent. The lack of monitoring of the CTRL group content therefore makes it hard to say with certainty what was and was not offered. Limited resources also contributed to having to prolong the interval between Time 1 data collection and the commencement of the intervention (MBGC and CTRL) to 4 months.
Directions for Future Research The results of this feasibility pilot RCT suggest proceeding to a larger, well-powered RCT to explore the
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efficacy of MBGC, with some changes. This study highlighted the complexities of an adequate CTRL arm. Although using existing support groups as a control allows comparison to a true ‘‘treatment as usual,’’ given the lack of control we experienced, in a full trial we suggest development of a CTRL arm that is study specific. An alternative might be to develop a CTRL arm based on traditional community support groups, but with 12 sessions and regular auditing. A future trial could also easily correct for the 4-month data collection window, collecting Time 1 data just prior to the initial MBGC session. A three-armed (EXP, treatment as usual, wait-list CTRL) pilot study might be considered. However, this methodology would be severely compromised given that uncomplicated bereavement is characterized by some degree of natural grief adaptation over time, likely influencing the baseline results of participants who would be placed on a wait-list control to receive the intervention later. Lastly, a future study might evaluate whether MBGC accelerates uncomplicated grief adaptation compared to a CTRL group.
CONCLUSION The meaning-making paradigm is a potentiallyappropriate guide for psychosocial interventions with bereft individuals whose assumptive framework is often ‘‘bleached of meaning’’ in the aftermath of death (Neimeyer, 2010b, p. 88). In view of this study’s limitations, the feasibility results, albeit promising, should be interpreted with care and caution. The ability of MBGC to mitigate psychological distress is not yet established. At this stage of intervention development, it is appropriate to claim that the pilot RCT of MBGC was feasible. Qualitative data concerning participant feedback suggest that MBGC may facilitate bereavement adaptation, but further testing is warranted before any definitive conclusions can be drawn.
ACKNOWLEDGMENTS Appreciation is extended to Laura Copeland who served as a research assistant for this project. Thanks to the following individuals and groups for early input on developing Meaning-Based Group Counseling: Dr. Pierre Gagnon; Dr. Keith Wilson; the Strategic Training Program in Palliative Care Research; the Coping and Resilience Research Team (McGill); and the Palliative Care McGill Research Team. The authors wish to thank a number of organizations who generously referred individuals for the study including
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Hope & Cope, Palliative Care McGill and affiliated Palliative Care Services, McGill Counseling Services, the McGill University Health Center and Jewish General Hospital’s Psychosocial Oncology Programs, CSSS Cavendish, Cedars CanSupport, and the Argyle Institute of Human Relations.
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FUNDING This research was supported by a Canadian Institutes of Health Research (CIHR) studentship to the primary author (CIHR #194779); the CIHR=Canadian Cancer Society Strategic Training Program in Palliative Care Research (#STI-63286); and the Family Caregiving at End of Life New Emerging Team (CIHR #129692). REFERENCES Breitbart, W., Rosenfeld, B., Gibson, C., Pessin, H., Poppito, S., Nelson, C., . . . Olden, M. (2010). Meaning-centered group psychotherapy for patients with advanced cancer: A pilot randomized controlled trial. Psycho-Oncology, 19, 21–28. Burnett, P., Middleton, W., Raphael, B., & Martinek, N. (1997). Measuring core bereavement phenomena. Psychological Medicine, 27, 49–57. Crumbaugh, J. C., & Maholick, L. T. (1964). An experimental study in existentialism: The psychometric approach to Frankl’s concept of noogenic neurosis. Journal of Clinical Psychology, 20, 200–207. Currier, J. M., Neimeyer, R. A., & Berman, J. S. (2008). The effectiveness of psychotherapeutic interventions for bereaved persons: A comprehensive quantitative review. Psychological Bulletin, 34, 648–661. Davidson, G. W. (1979). Hospice care for the dying. In H. Wass. & R. A. Neimeyer (Eds.), Dying: Facing the facts (pp. 158–181). Washington, DC: Hemisphere. Forte, A. L., Hill, M., Pazder, D., & Feudtner, C. (2004). Bereavement care interventions: A systematic review. BMC Palliative Care, 26(3), 1–14. Gillies, J. M., Neimeyer, R. A., & Milman, E. (2014). The Grief and Meaning Reconstruction Inventory (GMRI): Initial validation of a new measure. Death Studies, 39, 61–74. Hill, C. E., Zack, J. S., Wonnell, T. L., Hoffman, M. A., Rochlen, A. B., Goldberg, J. L., . . . Hess, S. (2000). Structured brief therapy with a focus on dreams or loss for clients with troubling dreams and recent loss. Journal of Counseling Psychology, 47, 90–101. Hilliard, R. E. (2001). The effects of music therapy-based bereavement groups on mood and behavior of grieving children: A pilot study. Journal of Music Therapy, 38, 291–306. Hogan, N. S., Greenfield, D., & Schmidt, L. (2001). Development and validation of the Hogan Grief Reaction Checklist. Death Studies, 25, 1–32. Holland, J. M., Currier, J. M., Coleman, R. A., & Neimeyer, R. A. (2010). The Integration of Stressful Life Experiences Scale (ISLES): Development and initial validation of a new measure. International Journal of Stress Management, 17, 325–352. Holland, J. M., Neimeyer, R. A., Boelen, P. A., & Prigerson, H. G. (2008). The underlying structure of grief: A taxonometric investigation of prolonged and normal reactions to loss. Journal of Psychopathology and Behavioral Assessment, 31, 190–201.
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Radloff, L. S. (1977). The CES-D Scale: A self report depression scale for research in the general population. Psychological Measurement, 1, 385–401. Rounsaville, B. J., Carroll, K. M., & Onken, L. S. (2001). A stage model of behavioural therapies research: Getting started and moving on from stage 1. Clinical Psychology: Science and Practice, 8(2), 133–142. Schut, H., & Stroebe, M. S. (2005). Interventions to enhance adaptation to bereavement. Journal of Palliative Medicine, 8(Suppl 1), S140–S147. Spielberger, C. D., Gorsuch, R. L., Lushene, R., Vagg, P. R., & Jacobs, G. A. (1983). State-Trait Anxiety Inventory for adults: Sampler set, manual, instrument, and scoring guide. Menlo Park, CA: Mind Garden. Stroebe, M. S., & Schut, H. (1999). The dual process model of coping with bereavement: Rationale and description. Death Studies, 23, 197–224.
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Stroebe, M. S., Hansson, R., Stroebe, W., & Schut, H. (2001). Introduction: Concepts and issues in contemporary research on bereavment. In M. S. Stroebe, R. Hansson, W. Stroebe, & H. Schut (Eds.), Handbook of bereavement research (pp. 3–23). Washinton: APA. Stroebe, M. S., Schut, H., & Stroebe, W. (2007). Health outcomes of bereavement. The Lancet, 370, 1960–1973. van Meijel, B., Gamel, C., van Swieten-Duijfjes, B., & Grypdonck, M. H. F. (2004). The development of evidence-based nursing interventions: Methodological considerations. Journal of Advanced Nursing, 48(1), 84–92. Yalom, I. D., & Leszcz, M. (2005). The theory and practice of group psychotherapy (5th ed.). New York, NY: Basic Books.
Death Studies Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/udst20
Reconstructing Meaning with Others in Loss: A Feasibility Pilot Randomized Controlled Trial of a Bereavement Group ab
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Christopher J. MacKinnon , Nathan Grant Smith , Melissa Henry , Evgenia Milman , Harvey g
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M. Chochinov , Annette Körner , Mel Berish , Amanda Jessica Farrace , Nikoleta Liarikos & S. Robin Cohen a
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Department of Oncology, McGill University, Montreal, Québec, Canada
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Balfour Mount Palliative Care Unit, McGill University Health Center, Montreal, Québec, Canada c
Department of Psychological, Health, and Learning Sciences, University of Houston, Houston, Texas, USA d
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Department of Oncology, Psychology, and Otolaryngology–Head and Neck Surgery, McGill University, Montreal, Québec, Canada e
Lady-Davis Institute for Medical Research and Segal Cancer Centre, Jewish General Hospital, Montreal, Québec, Canada f
Department of Educational & Counseling Psychology, McGill University, Montreal, Québec, Canada g
Community Health Sciences, and Family Medicine (Division of Palliative Care), University of Manitoba, Winnipeg, Manitoba, Canada h
Champlain Regional College, St-Lambert, Québec, Canada
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Palliative Care Research, Jewish General Hospital, Montreal, Québec, Canada
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Hope & Cope, Jewish General Hospital, Montreal, Québec, Canada
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Programs in Palliative Care, Departments of Oncology and Medicine, McGill University, Montreal, Québec, Canada Accepted author version posted online: 12 Feb 2015.Published online: 12 Feb 2015.
To cite this article: Christopher J. MacKinnon, Nathan Grant Smith, Melissa Henry, Evgenia Milman, Harvey M. Chochinov, Annette Körner, Mel Berish, Amanda Jessica Farrace, Nikoleta Liarikos & S. Robin Cohen (2015) Reconstructing Meaning with Others in Loss: A Feasibility Pilot Randomized Controlled Trial of a Bereavement Group, Death Studies, 39:7, 411-421, DOI: 10.1080/07481187.2014.958628 To link to this article: http://dx.doi.org/10.1080/07481187.2014.958628
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Death Studies, 39: 411–421, 2015 Copyright # Taylor & Francis Group, LLC ISSN: 0748-1187 print=1091-7683 online DOI: 10.1080/07481187.2014.958628
Reconstructing Meaning with Others in Loss: A Feasibility Pilot Randomized Controlled Trial of a Bereavement Group Christopher J. MacKinnon
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Department of Oncology, McGill University, Montreal, Que´bec, Canada and Balfour Mount Palliative Care Unit, McGill University Health Center, Montreal, Que´bec, Canada
Nathan Grant Smith Department of Psychological, Health, and Learning Sciences, University of Houston, Houston, Texas, USA
Melissa Henry Department of Oncology, Psychology, and Otolaryngology–Head and Neck Surgery, McGill University, Montreal, Que´bec, Canada and Lady-Davis Institute for Medical Research and Segal Cancer Centre, Jewish General Hospital, Montreal, Que´bec, Canada
Evgenia Milman Department of Educational & Counseling Psychology, McGill University, Montreal, Que´bec, Canada
Harvey M. Chochinov Community Health Sciences, and Family Medicine (Division of Palliative Care), University of Manitoba, Winnipeg, Manitoba, Canada
Annette Ko¨rner Department of Educational & Counseling Psychology, McGill University, Montreal, Que´bec, Canada
Mel Berish Champlain Regional College, St-Lambert, Que´bec, Canada
Amanda Jessica Farrace Palliative Care Research, Jewish General Hospital, Montreal, Que´bec, Canada
Nikoleta Liarikos Hope & Cope, Jewish General Hospital, Montreal, Que´bec, Canada
S. Robin Cohen Programs in Palliative Care, Departments of Oncology and Medicine, McGill University, Montreal, Que´bec, Canada and Lady Davis Institute, Montreal, Que´bec, Canada
Received 4 July 2013; accepted 13 August 2014. Address correspondence to Christopher J. MacKinnon, Balfour Mount Palliative Care Unit, McGill University Health Center, 1001 Boulevard De´carie, Montreal, Que´bec, Canada, H4A 3J1. E-mail: [email protected]
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More effective psychosocial interventions that target uncomplicated bereavement are needed for those actively seeking support. The objective of this study was to assess the feasibility of evaluating a unique meaning-based group counseling (MBGC) intervention with a randomized controlled trial (RCT) design. Twenty-six bereft individuals were randomly assigned to either MBGC or a control bereavement support group. Twenty participants (11 experimental, nine control) completed all aspects of the study including self-report measures at baseline, postintervention, and 3-month follow-up of meaning in life, anxiety, depression, and grief. Results support the feasibility of an RCT with MBGC.
Uncomplicated grief is characterized by significant distress that does not impair social, occupational, or daily functioning (Stroebe, Hansson, Stroebe, & Schut, 2001). Correspondingly, the meaning-making paradigm (Neimeyer & Sands, 2011) is a contemporary and perhaps potent framework to understand bereavement. Meaning-making in bereavement can involve a process of re-establishing psychological well-being through finding benefits and reconstructing one’s identity after a death, as well as making sense of one’s own responses to loss (MacKinnon, Milman, et al., 2013; Neimeyer & Anderson, 2002). Attempts to translate this knowledge into clinical practice are flourishing (Neimeyer, 2012c) with increasing empirical evidence (Park, 2010). However, the meaning-making approach does not yet extend into the general bereavement support group literature. As such, we developed meaning-based group counseling (MBGC) (MacKinnon, Smith, et al., 2013). In an initial study we conducted a preliminary test and subsequently revised MBGC to ensure feasibility of both the intervention and the questionnaire battery (MacKinnon et al., 2015). The current article reports the next stage in intervention development: the feasibility results of a pilot randomized controlled trial (RCT).
BACKGROUND Past reviews have suggested that interventions for uncomplicated grief were not beneficial in reducing future psychological distress (Genevro, Marshall, & Miller, 2004) and may impede grieving processes (Stroebe, Schut, & Stroebe, 2007). Conversely, others have argued that past studies have been severely hampered by methodological biases, suggesting that any definitive conclusions of uncomplicated bereavement interventions are premature (Larson & Hoyt, 2007). Interventions often fail to specify a theoretical framework or are guided with excessive theories, as well as rely on methods that fail to properly randomize participants, or have a control group (Forte, Hill, Pazder, & Feudtner, 2004). Methods of intervention testing also tend not to be well-described, use nonvalidated outcome measures, and lack explicit indications for success
(Schut et al., 2001). Studies also tend to have inconsistent inclusion criteria or fail to screen participants (Currier, Neimeyer, & Berman, 2008). Lastly, past studies have not encouraged self-selection (see Schut & Stroebe, 2005), which is important in helping those with uncomplicated bereavement. Our rationale in creating MBGC was to develop and test a distinctive group intervention for uncomplicated bereavement that addresses a previously unexplored topic, specifically the intersections between meaning making and bereavement group counseling. The goal of MBGC is to influence meaning making; in preparing this study we could not locate any published bereavement support group literature that targets meaning making. We hypothesized that a focus on meaning making, as well as attempts to attend to the aforementioned methodological concerns, might set the stage for improving the historically poor outcomes of uncomplicated grief interventions. The objective of this study was to ascertain the feasibility of a pilot RCT with MBGC, using a larger sample size than the initial testing (n ¼ 9, MacKinnon et al., 2015). Secondary objectives included (a) identifying further refinements to MBGC based on participant feedback; (b) assessing if the outcome measures remain acceptable to participants; (c) ascertaining if randomization is feasible and whether a sufficient number of participants completed data collection; and (d) deciding whether the results support proceeding with a full RCT. To address these objectives, the study adhered to a formative evaluation methodology specified in the Stage Model of Behavior Therapy Research (Rounsaville, Carroll, & Onken, 2001). Consistent with the goals of pilot studies (van Meijel, Gamel, van Swieten-Duijfjes, & Grypdonck, 2004), the research objectives did not include an assessment of statistically significant differences as the small sample size would likely overestimate any effects of the intervention (Lancaster, Dodd, & Williamson, 2004).
METHODS The study was approved by the Jewish General Hospital Research Ethics Committee. It was registered with ClinicalTrials.gov prior to recruitment. The study design
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was a two-arm (experimental [EXP] and control [CTRL]) by three-repeated-measures (pre, post, and follow-up) pilot RCT. Outcome measures were administered at three times: Time 1 (T1), within the 4 months prior to the start of the study across both arms (respective intervention [MBGC or CTRL]); Time 2 (T2), within 2 weeks of intervention completion; and Time 3 (T3), 3 months following intervention completion of the respective study arm. Failure to complete either the T2 or T3 measures resulted in the participant’s data being withdrawn from the descriptive statistical analyses. Feasibility and acceptability threshold criteria for claiming success were established a priori as such: (a) qualitative data indicated that individuals did not experience an overall detrimental effect from participating in MBGC; (b) there was no substantial attrition (i.e., dropouts resulted in less than four members in either treatment arm); and (c) the majority of participants completed all questionnaire batteries. Study Population, Recruitment, and Randomization Recruitment was in collaboration with a community organization associated with an urban university teaching hospital. The study was announced by posters displayed at various healthcare agencies. As this pilot study was not intended to identify significant differences, a sample size of 24–32 was selected (consistent with similar bereavement group studies; e.g., Hilliard, 2001, N ¼ 18). Individuals were eligible to participate in the study if they met the following criteria: (a) 18 years of age at the time of the first group session; (b) actively seeking support for themselves; (c) experiencing an uncomplicated grief trajectory (defined as grief occurring within 6 weeks to 2 years following the death);1 (d) and with an absence of grief symptoms (e.g., yearning, sadness, intrusive thoughts of the deceased, see Shear et al., 2011) that impaired daily functioning as reported by participants; (e) ability to speak and read in English; and (f) ability to function in a group following the selection recommendations of Yalom and Leszcz (2005). Candidates were excluded if they were (a) experiencing a prolonged grief response;2 (b) a parent grieving the death of a child under 18 years old; (c) grieving a suicide or homicide death; or (d) exhibiting personality traits counter-productive for a group (e.g., Axis II disorders on DSM-IV-TR).
1
This timeframe corresponds to the framework of common grief adaptation as described by both Prigerson and Maciejewski (2008b) as well as Davidson (1979) as reported by Neimeyer (2006). 2 Prolonged grief disorder is defined as a state that endures for at least 6 months and includes grief-related psychological distress that impairs functioning (Holland, Neimeyer, Boelen, & Prigerson, 2008).
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Candidates were invited to take part in a screening interview after giving written informed consent. They then completed a demographic form. Interviews ranged from 30 to 90 min depending on the level of psychological distress. Interviews were conducted by Christopher J. MacKinnon and, when possible, with Nikoleta Liarikos, each a facilitator in one of the study arms. The Psychosocial Assessment Elements (Keefler, 2005) interview guide was used to structure the interview and gauge current psychological functioning. The Prolonged Grief Disorder 13 (PG-13; Prigerson & Maciejewiski, 2008a) was used to inform a clinical profile of prolonged grief after 6 months.3 As the PG-13 remains in the early stages of empirical validation, final decision for inclusion or exclusion rested on the clinical judgment of the interviewers and not reliance on a cut-off score. Once deemed eligible, participants were randomized to the EXP or CTRL group in a 1:1 ratio. Block randomization prevented the researchers conducting the screening interviews from forecasting which arm participants would be randomized to. Randomization was accomplished using a random number generator (www.random.org) following CONSORT guidelines. The number of participants in each group ranged from six to eight, following standard support group size conventions (see Yalom & Leszcz, 2005). Experimental Condition MBGC for bereavement is an original and manualized intervention developed for adults experiencing uncomplicated grief (MacKinnon, Smith, et al., 2013). MBGC is comprised of various semistructured meaning-based tasks and themes embedded over 12 weekly sessions of 90 min (see Table 1). Two licensed mental health professionals co-facilitated all MBGC sessions. A research assistant (RA) was also present who functioned as an observer. Facilitators received training before delivery of MBGC from Christopher J. MacKinnon. Control Condition The CTRL arm was a treatment-as-usual bereavement support group. These CTRL support groups were part of a longstanding program conducted by the same community organization associated with recruitment. Group sessions took place biweekly with a total of seven 90-min sessions. The CTRL group followed more conventional bereavement support group themes, though assumed a relatively unstructured and atheoretical approach (see Table 2). The CTRL group (which has run for years)
3
The PG-13 is not designed to be given until six months after the death.
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C. J. MACKINNON ET AL. TABLE 1 Experimental Arm: Weekly Meaning-Based Group Counseling Session 1 2 3 4 5 6 7
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8 9 10 11 12
Tasks and themes Establishing norms; Exploring bereavement narratives Conventional bereavement group themes; members share meaningful objects associated with the deceased The Griefline Exercise; meaningful events Understandings and applications of the Theory of Shattered Assumptions (Janoff-Bulman, 1992) Understandings of the Dual Process Model (Stroebe & Schut, 1999) Sharing perceived changes in self and the family in the aftermath of loss Discussing the meaning of dreaming about the deceased (Hill, Zack, Wonnell, Hoffman, Rochlen, et al., 2000); Hello Again Letter (Neimeyer, 2012a) introduced Exploring member’s responses to the Hello Again Letter Identifying creative, attitudinal, and spiritual meaning sources (Breitbart, Rosenfeld, Gibson, Pessin, Poppito, et al., 2010); Life Imprints (Neimeyer, 2012b) introduced Exploring member’s responses to the Life Imprints Exploring the meaning of the group and its impending conclusion Gains made and future directions
has never had an explicit focus on meaning as reported by the CTRL facilitators. CTRL groups were each facilitated by two lay volunteers (nonprofessionals); in one group a licensed social worker acted as a third facilitator. Facilitators in the CTRL arm had received prior training in bereavement group facilitation through the community organization. Treatment Fidelity and Integrity For the EXP group, a treatment fidelity and integrity checklist (developed specifically for this study based on the components of MBGC) was completed every session by the RA and the two facilitators to ascertain adherence to the MBGC protocol. Comparison of each treatment fidelity checklist indicated that MBGC was delivered consistently with facilitators closely adhering to the intervention manual. The CTRL arm was not audited due to resource limitations. Masking Neither participants nor researchers were blind to treatment arm randomization. Although there was no reason to expect interaction between members of different
groups, in order to minimize cross-contamination participants were asked to only discuss the intervention with other members of their respective groups. Facilitators did not examine participants’ responses to the outcome questionnaires until after follow-up data were collected. Qualitative Data Sources To effect possible further refinements to MBGC and assess participants’ responses to MBGC, several qualitative data sources were accumulated in the EXP condition. Independent field notes were written by the cofacilitators for each session. Second, the RA completed a comprehensive observation protocol with the purpose of attending to group meaning-making processes. Third, participants in the EXP arm were encouraged to provide feedback on the intervention and suggest changes throughout. Lastly, the sample was assessed for use of professional psychosocial services, as well as any psychotropic medications begun, taken, or adjusted during the study. No formal qualitative methodology was used to analyze these data sources, but rather participant responses and comments were solicited to convey their impressions and recommendations for improving both the measures and interventions.
TABLE 2 Control Arm: Biweekly Conventional Bereavement Support Group Session 1 2 3 4 5 6 7
Themes and tasks Introductions; Norm setting Symptoms of grief: Grieving Person’s Bill of Rights Feelings associated with grief, funeral, and presence at time of death Coping and support; Finding and establishing a support network Bereavement related film with discussion OR: Motivational speaker (not related to bereavement) Memories: Sharing keepsakes AND=OR music therapy session Recovery; Personal strengths; Journaling
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FIGURE 1 Participant flow.
Quantitative Outcome Measures Four primary outcomes were chosen: grief, depression, anxiety, and meaning in life. The majority of outcome measures were selected due to their assessment of grief symptomatology and psychometric properties. A few measures were chosen for their strong face validity. The outcomes of anxiety and depression were assessed with one measure each. Three questionnaires were chosen for each of the grief and meaning outcomes as those questionnaires have few studies demonstrating their psychometric reliability and validity. Questionnaires that specify a timeframe (e.g., the severity of a grief
symptom within the past 2 weeks) are explicitly noted below as several scales do not assess time. The three grief measures were as follows. First, the Revised Grief Experience Inventory (RGEI; Lev, Munro, & McCorkle, 1993) is designed to measure the grief experience. Second, the Core Bereavement Items instrument (CBI; Burnett, Middleton, Raphael, & Martinek, 1997) assesses frequently experienced phenomena in the bereaved. Lastly, the Hogan Grief Reaction Checklist (HGRC; Hogan, Greenfield, & Schmidt, 2001) consists of a list of thoughts and emotions an individual may have experienced within the past two weeks related to the
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death of a significant loved one. There are six subscales: blame and anger, detachment, despair, disorganization, panic behavior, and personal growth. Depression was assessed with the Center for Epidemiologic Studies Depression Scale (Radloff, 1977); it assesses symptoms of clinical depression within the past week. Anxiety was assessed using both subscales of the State-Trait Anxiety Inventory: state (a temporary variation in emotionality) and trait (a comparatively stable feature) (Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983) Of the three measures selected for the outcome of meaning in life, two are reported here.4 The Purpose in Life Test (PIL; Crumbaugh & Maholick, 1964) evaluates Frankl’s theory of existential meaning. The Integration of Stressful Life Experiences Scale (ISLES; Holland, Currier, Coleman, & Neimeyer, 2010) is designed to gauge the degree to which an individual is able to adaptively integrate a stressful life event. Only descriptive statistics were calculated for the outcome measures. The percentage of scale range changes between T1 and T3 was calculated for each instrument. RESULTS Data collection took place over 17 months. Progress of participants from recruitment and screening through each phase of the study is shown in Figure 1 (EXP n ¼ 11; CTRL n ¼ 9). Nineteen of 45 potential participants were excluded (42%). Recruitment Rate Participants were recruited over a period of 4 months prior to the beginning of their respective group. The majority of participants included in the study were referred by allied mental health professionals (n ¼ 17, 65%). On average, 6.5 individuals (SD ¼ 4.93; Mdn ¼ 6) signed consent, completed baseline questionnaires and were randomized each month. On average, a participant in the EXP arm needed to wait 26 days (SD ¼ 26.85; Mdn ¼ 14.5) before their respective group began. Those in the CTRL group waited on average 50 days (SD ¼ 39.15; Mdn ¼ 51.5). Wait times had to do with logistics, specifically scheduling group leaders and participants, as well as reserving space to conduct the groups. Sample Characteristics and Attendance Demographic data are summarized in Table 3. Participants were predominantly female, heterosexual, 4
The Grief and Meaning Reconstruction Inventory (GMRI; Gillies, Neimeyer, & Milman, 2014) was also administered though the results are not reported.
TABLE 3 Baseline Sociodemographic Variables ( Sample Sizes Vary With Missing Data) Experimental (n ¼ 14) M (SD) 52.36 (19.18)
Control (n ¼ 12) M (SD) 45.00 (15.31)
Age n
%
Gender Female 12 85.71 Male 2 14.28 Ethnicity Caucasian 12 85.71 Arabic 1 7.14 Asian 1 7.14 Latino=a 0 0.00 Sexual orientation Heterosexual 14 100.00 Bisexual 0 0.00 Homosexual 0 0.00 Spiritual=religious orientation Christian 4 28.57 Jewish 5 35.71 Atheist= 3 21.43 Nonreligious Agnostic 1 7.14 Muslim 1 7.14 Education ( Exp n ¼ 12; Ctrl n ¼ 11) Bachelors Degree 7 58.33 Masters or above 3 25.00 Elementary 1 8.33 High School 1 8.33 Family income ( Exp n ¼ 12 ; Ctrl n ¼ 10) Less than $20,000 0 0.00 CAD $20,001 to $39,999 1 8.33 CAD $40,000 to $59,999 4 33.33 CAD $60,000 to $79,999 6 50.00 CAD More than 1 8.33 $80,000 CAD Civil status Widowed 6 42.86 Single 4 28.57 Married=common 2 14.29 law Partnered but 2 14.29 living alone Relationship being presently grieved Parent 5 35.71 Spouse 6 42.86 Friend 1 7.14 Sibling 1 7.14 Grandparent 1 7.14 Previous death-related losses 0 4 28.57 1 4 28.57 2 or more 6 42.86
n
%
10 2
83.33 16.67
10 0 0 1
83.33 0 0 8.33
10 2 0
83.33 16.67 0.00
9 1 1
75.00 8.33 8.33
1 0
8.33 0.00
6 3 1 1
54.54 27.27 9.09 9.09
1
10.00
2
20.00
2
20.00
2
20.00
3
30.00
4 4 3
33.33 33.33 25.00
1
8.33
6 4 1 1 0
50.00 33.33 8.33 8.33 0.00
5 4 3
41.67 33.33 16.67
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religiously identified as either Jewish or Christian, and of Caucasian ethnicity. The mean attendance in MBGC was 86%, corresponding to 10.3 out of 12 sessions (SD ¼ 0.95). Comparatively, those in the CTRL arm attended on average 74% (M ¼ 5.20, SD ¼ 0.79) of seven sessions available.
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Contamination No participant in the EXP arm reported discussing the study with anyone in the CTRL arm (and vice-versa). In addition, data were collected to assess external support participants sought during the study, as well as possible contamination across treatment arms. Missing data resulted in responses from only 18 participants (69%). Four participants (29%) in the EXP arm and one participant in the CTRL arm (10%) reported participation in concurrent individual psychotherapy. A minority of participants reported taking either anti-depressants or anxiolytics (EXP [n ¼ 4, 40%]; CTRL [n ¼ 1, 13%]). Descriptive Statistical Results Quantitative data were analyzed using SPSS version 19. Participants generally completed the entire questionnaire battery with six individuals (23%; two EXP, two CTRL) lost to attrition (see Figure 1). Table 4 contains means and standard deviations of the outcome measures at all
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three timepoints. A comparison of averages suggests that the EXP group on the whole had lower average meaning and higher depression at baseline compared to the CTRL group. Means across the anxiety and grief measures were similar across treatment arms at T1. Looking at trends across the three time periods, mean scores in the CTRL group improved at 2 weeks postintervention, though were often not maintained at 3-month follow-up (T3). Conversely, some measures in the EXP group showed moderate mean improvement at 2 weeks after the intervention that was either maintained or continued to improve 3 months postintervention. Figure 2 contains percentage of scale range changes between T1 and T3. Responses to MBGC There were no major refinements indicated to the intervention during this study. In addition, no participants reported withdrawing from the study due to increased psychological distress. Most participants (n ¼ 18, 90%) found the questionnaire battery acceptable (i.e., no consistent negative comments on items or scales). There were minimal missing data, with the maximum being 20% for two items. Some participants wrote comments in the margins of the measure, often adding contextual details. For example, some participants felt that their responses to the outcome measures were influenced by
TABLE 4 Descriptive Results
T1: Baseline Mean (SD) Measure (with range) RGEI (22–135) CBI (0–51) HGRCy Blame and anger (7–35) Despair (13–65) Detachment (8–40) Disorganization (7–35) Panic behavior (14–70) Personal growth (12–60) CES-D (0–60) STAI: State (20–80) STAI: Trait (20–80) PIL (15–105) ISLES (16–80)
EXP (n ¼ 11)
CTRL (n ¼ 9)
T2: 2 weeks post-intervention Mean (SD) EXP (n ¼ 11)
CTRL (n ¼ 9)
T3: 3 months post-intervention follow-up Mean (SD) EXP (n ¼ 11)
CTRL (n ¼ 9)
a
67.29 (17.55)a 24.33 (11.65)a
80.52 (12.43) 35.34 (8.73)
77.22 (22.66) 26.89 (11.87)
77.09 (16.30) 31.68 (10.45)
76.57 (20.79) 26.44 (12.42)
73.45 (13.68) 25.01 (10.90)a
14.48 34.92 15.91 15.64 33.73 38.91 23.93 48.01 43.43 70.45 45.00
13.33 33.67 16.89 16.44 32.00 33.89 17.89 49.43 46.49 77.33 49.51
11.55 29.36 14.60 13.55 26.56 34.64 18.55 41.84 41.73 75.05 50.93
13.67 30.67 18.56 17.56 37.11 35.67 14.89 44.56 43.00 78.78 52.89
11.27 27.27 12.27 12.47 24.45 34.91 14.09 40.45 39.82 76.18 52.34
(8.59) (14.37) (6.36) (4.32) (15.82) (14.65) (13.54) (14.77) (13.56) (20.90) (16.17)
(6.34) (15.40) (8.27) (6.88) (9.06) (11.12) (14.97) (12.05) (18.34) (12.92) (15.59)
(4.89) (12.49) (5.63) (4.48) (11.05) (11.72) (11.47) (14.69) (12.16) (11.30) (13.52)
(5.48) (13.00) (8.85) (8.09) (13.20) (9.29) (10.15) (6.77) (7.26) (7.55) (13.05)
(5.24)a (11.91)a (4.65)a (4.37)a (10.41)a (14.61)a (10.33)a (10.88)a (9.86)a (10.54)a (14.84)a
12.00 25.44 17.17 16.89 29.29 33.89 11.22 44.11 41.44 76.78 51.56
(4.56)a (8.26)a (5.88)b (7.61)b (9.92)a (8.89)c (8.54)a (5.90)a (8.66)a (11.81)b (14.24)a
Note: Parenthesized ranges beside the scale names refer to minimum and maximum scores. EXP ¼ experimental arm; CTRL ¼ control arm; PIL ¼ Purpose in Life Test; ISLES ¼ Integration of Stressful Life Experiences Scale; STAI ¼ State-Trait Anxiety Inventory; CES-D ¼ Center for Epidemiological Studies Depression Scale; RGEI ¼ Revised Grief Experiences Inventory; CBI ¼ Core Bereavement Items; HRGC ¼ Hogan Grief Reaction Checklist. y There is no total score for the Hogan Grief Reaction Checklist. Reversed score: Lower scores are indicative of greater personal growth. a Score improved from baseline. b Score declined from baseline. c No change in scores from baseline.
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FIGURE 2 Percentage of scale range changes. EXP ¼ experimental arm; CTRL ¼ control arm; PIL ¼ Purpose in Life Test; ISLES ¼ Integration of Stressful Life Experiences Scale; STAI ¼ State-Trait Anxiety Inventory; CES-D ¼ Center for Epidemiological Studies Depression Scale; RGEI ¼ Revised Grief Experiences Inventory; CBI ¼ Core Bereavement Items; HRGC ¼ Hogan Grief Reaction Checklist.
recent health problems. Furthermore, participant feedback suggested that there is a need to develop grief measures that are more time sensitive as many reported that their symptoms of distress fluctuated greatly over time. Specifically the PIL, ISLES, RGEI, and CBI fail to set a timeframe for their items. Some participants made requests to have more homogeneity in the group. The desire to want to ‘‘be with people like me’’ was a common sentiment expressed during screening and may relate to the desire for normalization and validation of one’s grief experience. Conversely, the benefits of encountering dissimilar grief experiences of an objectively similar event (e.g., loss of a spouse) were identified by some participants by the conclusion of MBGC as one of the principal gains from participating. Participants also reported benefits from the meaning-based underpinnings of MBGC. Participants reported making more sense of their own particular bereavement response. The meaning-based written exercises (e.g., Neimeyer, 2012a) emerged as particularly beneficial, bringing about new insights in constructing more adaptive and less concrete continuing bonds with the deceased through the process of sharing responses with others.
DISCUSSION When the threshold criteria for success are examined, the results appear to indicate that the pilot RCT of MBGC was feasible. First, no individuals in the EXP condition reported overall greater levels of psychological distress following participation. Second, there was no substantial attrition during intervention delivery or data collection. Third, approximately 75% of participants completed all the questionnaire batteries. Recruitment for the study was relatively seamless.
Referrals from allied health care professionals tended to yield the greatest number of eligible individuals who were subsequently included in the study. Individuals in both treatment arms largely attended and completed their respective groups. Strong attendance suggests that some individuals in uncomplicated bereavement desire a form of more formal support to facilitate coping. The outcome measures appeared to be acceptable to individuals, with no major negative comments. The mean scores at 3 months for MBGC participants showed no worsening from baseline. In addition, the averages of most outcomes improved more at 3-month follow-up in the EXP than in the CTRL condition. Furthermore, consistent with the objective of re-evaluating the choice of outcome measures used in this pilot study (Lancaster et al., 2004), more sensitive measures that assess both state as well as trait grief and meaning with specific time frames (e.g., ‘‘within the past 2 weeks’’ is a common convention) are desirable. Participants reported that they were largely satisfied with the tasks and themes of MBGC, as well as the order in which they were presented. Although some participants desired more homogeneity of grief experience during screening, accommodating these requests poses a major challenge in that attempting to recruit participants using narrow inclusion criteria jeopardizes feasibility. Whereas striking a perfect balance between homo- and heterogeneity is challenging, participant responses to MBGC suggest that having a more diverse membership (e.g., age range, gender, relationship to the deceased) may provide added benefits compared to a strictly homogeneous group composition (echoing Yalom & Leszcz, 2005; see MacKinnon et al., 2015). This pilot RCT attempted to address a number of previous critiques of past studies for uncomplicated grief. Attending to past design flaws may have facilitated some of the promising results reported in this pilot
MEANING AND GROUP BEREAVEMENT
study. Nevertheless, this pilot revealed some flaws in our design as well, as specified below in the Limitations section. The discussion of limitations lays the foundation for further investigations.
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Limitations As is expected in a feasibility pilot study, no cause-andeffect outcomes can be concluded. In addition to any effect of MBGC, larger mean improvements in the EXP group than the CTRL group may be due to more concurrent individual psychotherapy as well as more use of prescribed psychotropic medications in the EXP group. Furthermore, those in the EXP arm may have had higher levels of psychological distress at baseline than CTRLs. Because the CTRL group started at lower levels of depression and higher levels of meaning, there may have been less space for improvement, whereas the larger improvements in the EXP arm may be in part due to regression towards the mean. Limited success was made in attempting to address previous critiques concerning problematic CTRL groups in bereavement intervention design (Schut & Stroebe, 2005). While some of the limitations of a treatment-asusual CTRL could have been predicted, in designing the study it was decided that there were sufficient benefits as this method permitted a partial appraisal of customary practices of interventions for uncomplicated grief that may be indicative of common norms in the field. This decision also resulted in several procedural dilemmas that curbed methodological rigor. Specifically, comparisons of the EXP and CTRL arms were confounded by greater absenteeism and attrition in the CTRL groups, and different frequencies and number of sessions in each treatment arm. The EXP condition provided almost double the number of sessions and may have created an imbalanced response in participants. Facilitation of each intervention was also confounded in that the EXP groups were consistently led by licensed mental health professionals whereas one CTRL group was led by trained volunteers with a social worker and another with only trained volunteers. Moreover, the tasks and themes in each of the two CTRL groups were inconsistent. The lack of monitoring of the CTRL group content therefore makes it hard to say with certainty what was and was not offered. Limited resources also contributed to having to prolong the interval between Time 1 data collection and the commencement of the intervention (MBGC and CTRL) to 4 months.
Directions for Future Research The results of this feasibility pilot RCT suggest proceeding to a larger, well-powered RCT to explore the
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efficacy of MBGC, with some changes. This study highlighted the complexities of an adequate CTRL arm. Although using existing support groups as a control allows comparison to a true ‘‘treatment as usual,’’ given the lack of control we experienced, in a full trial we suggest development of a CTRL arm that is study specific. An alternative might be to develop a CTRL arm based on traditional community support groups, but with 12 sessions and regular auditing. A future trial could also easily correct for the 4-month data collection window, collecting Time 1 data just prior to the initial MBGC session. A three-armed (EXP, treatment as usual, wait-list CTRL) pilot study might be considered. However, this methodology would be severely compromised given that uncomplicated bereavement is characterized by some degree of natural grief adaptation over time, likely influencing the baseline results of participants who would be placed on a wait-list control to receive the intervention later. Lastly, a future study might evaluate whether MBGC accelerates uncomplicated grief adaptation compared to a CTRL group.
CONCLUSION The meaning-making paradigm is a potentiallyappropriate guide for psychosocial interventions with bereft individuals whose assumptive framework is often ‘‘bleached of meaning’’ in the aftermath of death (Neimeyer, 2010b, p. 88). In view of this study’s limitations, the feasibility results, albeit promising, should be interpreted with care and caution. The ability of MBGC to mitigate psychological distress is not yet established. At this stage of intervention development, it is appropriate to claim that the pilot RCT of MBGC was feasible. Qualitative data concerning participant feedback suggest that MBGC may facilitate bereavement adaptation, but further testing is warranted before any definitive conclusions can be drawn.
ACKNOWLEDGMENTS Appreciation is extended to Laura Copeland who served as a research assistant for this project. Thanks to the following individuals and groups for early input on developing Meaning-Based Group Counseling: Dr. Pierre Gagnon; Dr. Keith Wilson; the Strategic Training Program in Palliative Care Research; the Coping and Resilience Research Team (McGill); and the Palliative Care McGill Research Team. The authors wish to thank a number of organizations who generously referred individuals for the study including
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Hope & Cope, Palliative Care McGill and affiliated Palliative Care Services, McGill Counseling Services, the McGill University Health Center and Jewish General Hospital’s Psychosocial Oncology Programs, CSSS Cavendish, Cedars CanSupport, and the Argyle Institute of Human Relations.
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FUNDING This research was supported by a Canadian Institutes of Health Research (CIHR) studentship to the primary author (CIHR #194779); the CIHR=Canadian Cancer Society Strategic Training Program in Palliative Care Research (#STI-63286); and the Family Caregiving at End of Life New Emerging Team (CIHR #129692). REFERENCES Breitbart, W., Rosenfeld, B., Gibson, C., Pessin, H., Poppito, S., Nelson, C., . . . Olden, M. (2010). Meaning-centered group psychotherapy for patients with advanced cancer: A pilot randomized controlled trial. Psycho-Oncology, 19, 21–28. Burnett, P., Middleton, W., Raphael, B., & Martinek, N. (1997). Measuring core bereavement phenomena. Psychological Medicine, 27, 49–57. Crumbaugh, J. C., & Maholick, L. T. (1964). An experimental study in existentialism: The psychometric approach to Frankl’s concept of noogenic neurosis. Journal of Clinical Psychology, 20, 200–207. Currier, J. M., Neimeyer, R. A., & Berman, J. S. (2008). The effectiveness of psychotherapeutic interventions for bereaved persons: A comprehensive quantitative review. Psychological Bulletin, 34, 648–661. Davidson, G. W. (1979). Hospice care for the dying. In H. Wass. & R. A. Neimeyer (Eds.), Dying: Facing the facts (pp. 158–181). Washington, DC: Hemisphere. Forte, A. L., Hill, M., Pazder, D., & Feudtner, C. (2004). Bereavement care interventions: A systematic review. BMC Palliative Care, 26(3), 1–14. Gillies, J. M., Neimeyer, R. A., & Milman, E. (2014). The Grief and Meaning Reconstruction Inventory (GMRI): Initial validation of a new measure. Death Studies, 39, 61–74. Hill, C. E., Zack, J. S., Wonnell, T. L., Hoffman, M. A., Rochlen, A. B., Goldberg, J. L., . . . Hess, S. (2000). Structured brief therapy with a focus on dreams or loss for clients with troubling dreams and recent loss. Journal of Counseling Psychology, 47, 90–101. Hilliard, R. E. (2001). The effects of music therapy-based bereavement groups on mood and behavior of grieving children: A pilot study. Journal of Music Therapy, 38, 291–306. Hogan, N. S., Greenfield, D., & Schmidt, L. (2001). Development and validation of the Hogan Grief Reaction Checklist. Death Studies, 25, 1–32. Holland, J. M., Currier, J. M., Coleman, R. A., & Neimeyer, R. A. (2010). The Integration of Stressful Life Experiences Scale (ISLES): Development and initial validation of a new measure. International Journal of Stress Management, 17, 325–352. Holland, J. M., Neimeyer, R. A., Boelen, P. A., & Prigerson, H. G. (2008). The underlying structure of grief: A taxonometric investigation of prolonged and normal reactions to loss. Journal of Psychopathology and Behavioral Assessment, 31, 190–201.
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