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Brief strategic therapy in first myocardial infarction patients with increased levels of stress. A randomized clinical trial a

Jadwiga Małgorzata Rakowska a

Department of Psychopathology and Psychotherapy, Faculty of Psychology, University of Warsaw, Poland Accepted author version posted online: 08 Jan 2015.

Click for updates To cite this article: Jadwiga Małgorzata Rakowska (2015): Brief strategic therapy in first myocardial infarction patients with increased levels of stress. A randomized clinical trial, Anxiety, Stress, & Coping: An International Journal, DOI: 10.1080/10615806.2015.1004323 To link to this article: http://dx.doi.org/10.1080/10615806.2015.1004323

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Publisher: Taylor & Francis Journal: Anxiety, Stress, & Coping DOI: http://dx.doi.org/10.1080/10615806.2015.1004323

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Brief Strategic Therapy in First Myocardial Infarction Patients with Increased Levels of Stress. A Randomized Clinical Trial

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Department of Psychopathology and Psychotherapy, Faculty of Psychology, University of Warsaw, Poland

1.1.1 Wydział Psychologii, ul. Stawki 5/7, 00-183 Warszawa

1.1.3 Fax: (+48 22) 63 57 991

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1.1.2 Phone: (+48 22) 831 55 36

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1.1.4 E-mail: [email protected]

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ACKNOWLEDGEMENTS

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The study was supported by grant nr. 144525/2009 for statutory research from the Faculty of Psychology, University of Warsaw. This study was given organizational support by the late professor Leszek Kubik, head of the

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Jadwiga Małgorzata Rakowska, Ph.D.

cardiology ward of the Military Institute of Medicine in Warsaw. ABSTRACT

Background: Little is known about the impact of interventions targeting chronic stress levels on clinical outcomes among myocardial infarction patients with increased levels of stress.

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Objectives: To examine the impact of the addition of brief strategic therapy to usual care on clinical outcomes in first myocardial infarction patients with increased levels of stress.

Design: Eighty-one patients were randomly assigned to brief strategic therapy in conjunction with usual care (medical treatment, risk factor information and guidance on unhealthy

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behavior change) or to usual care.

Methods: The outcome measures were scores on the Perceived Stress Scale, reinfarction and

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treatment, and at two follow-ups.

Results: Patients subjected to brief strategic therapy showed reduced perceived stress at posttreatment and maintained decreased levels at follow-ups. At 1-year follow-up, they had a

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lower rate of non-fatal reinfarction, and at 2.5-year follow-up, they had a lower rate of fatal reinfarction. Their mental and physical health was improved at post-treatment and this was

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sustained at follow-ups.

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Conclusion: The addition of brief strategic therapy to usual care favorably influences the

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disease course after myocardial infarction in patients with increased levels of stress.

Key words: brief strategic therapy, first myocardial infarction patients with increased levels of perceived stress, non-fatal reinfarction, fatal reinfarction, mental and physical health status

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cardiac mortality rates, and scores on the Health Survey. Measures were taken before, post-

1.1.4.1

1.1.4.2

1.1.4.3 INTRODUCTION There are findings that show chronic stress as a risk factor for the occurrence of reinfarction or sudden cardiac death and lack of health improvement in patients after

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myocardial infarction (MI). Patients who survived a MI and experience increased levels of chronic stress have subsequent reinfarction or cardiac death more often, as compared to MI patients who experience low levels of stress (Arnold, et al., 2012; Frasure- Smith, 1991). Furthermore, these patients are characterized by worse disease – specific and generic health status after a MI as compared to those who experience low levels of chronic stress (Arnold et

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al., 2012). These findings suggest that, among MI patients who are defined by increased levels of chronic stress, decreasing chronic stress has the potential for preventing reinfarction

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There are findings that suggest that the presence of psychosocial stressors in the lives of people after a MI is associated with an increased risk of the occurrence of reinfarction or

sudden cardiac death. Reinfarction or sudden cardiac death were predicted by marital conflicts in female MI patients (Orth-Gomér et al., 2000), and by low perceived social support in male

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and female patients (Greenwood et al., 1999; Burg et al 2005). Sudden cardiac death was

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predicted by social isolation and high stress caused by aversive life events in male patients (Ruberman et al., 1984). Rate of cardiac death was four times more frequent among these

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patients than among those with low isolation and stress levels. These findings lead to the same conclusion as the one formulated in the paragraph above. Therefore, it is important to

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examine whether psychological interventions targeting chronic stress levels and coping skills may attenuate the increased morbidity and mortality risk from increased stress in MI

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or sudden cardiac death as well as for an improvement of health status.

populations.

The purpose of the present study was to test the hypothesis that, for MI patients with

increased levels of perceived stress, an intervention targeting chronic stress levels and coping skills in conjunction with usual medical care would contribute to perceived stress reduction and would have an impact on clinical outcomes. Brief Strategic Therapy (BST; the Mental Research Institute model; Watzlawick, Weakland, & Fish, 1974; Fish, Weakland, & Segal,

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1982) was used because it provides a useful framework for stimulating adaptive coping with psychosocial stress-related problems by incorporating interventions targeting skills for coping with stress and tailoring treatment to the specific needs of individuals. The control condition for the BST condition was to provide the usual medical care (UC). The outcomes were reduced stress, lower non-fatal myocardial infarction and cardiac mortality rates, and

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improved self-report generic health status.

1.1.4.4 METHODS

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1.1.4.6 Participants were male and female patients with a first non-

fatal MI diagnosis (ICD-10 code 121; WHO, 1994) who were aged 40– 65 years (M = 53.4). The age range of subjects is a result of

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willingness of patients of this age to take part in the study. The

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sample was predominantly employed - 95% worked and 5% were on a pension. Inclusion criteria were: having a diagnosis of a first non-

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fatal myocardial infarction; having increased levels of perceived

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stress in connection with psychosocial stress-related problems; and willingness to receive psychological help to control psychosocial

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1.1.4.5 Participants

stress-related problems. Planned exclusion criteria were severe mental problems (e.g., alcohol dependence or a psychosis). 1.1.4.7 Trial Design This was a parallel-group study with individuals randomly assigned to one of two groups: a

usual care (UC) group; and a brief strategic therapy plus usual care (BST) group. A

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constructive outcome strategy was used that identifies components or other treatments that can be added to typical treatment in order to enhance therapeutic change. Different treatment components were used for each of the two groups in the study. To determine an adequate sample size for group comparison analyses, an intended sample size was calculated for perceived stress as the primary outcome measure (Campbell,

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Julious, Altman, 1995). An alpha of .05 was adopted, a level of power of .80 was accepted, effect sizes .40 and .80 according to Cohen (1988) were estimated, standard deviation of the

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Power version 3.0.10 (Faul, 2008), indicated that the size of the groups needed to detect an effect size estimated at .40 was 78 subjects per group, and the size of the groups needed to

detect an effect size estimated at .80 was 21 subjects per group. Interim analyses of efficacy were planned when 40 subjects per group (in BST and UC conditions) had received treatment.

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The analyses were performed using the O’Brien-Fleming stopping boundaries (O'Brien, &

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Fleming, 1979). Three between–group comparisons were planned (at post-treatment, and at two follow-ups). For these comparisons, z-values were calculated and p-values matched. In

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the last follow-up analysis, a z-value of 2.004 (p = .045) was obtained. This is close to a conventional .05 significance level value, and no correction of the reported p-value for these

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interim tests was performed.

Treatment Conditions

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measurement was used, and the allowance for attrition was 10%. A computer program, G

All patients admitted to the current study received post-discharge medication

therapy at the discretion of their physicians according to a patient-focused care plan. Four types of drugs were used: antiplatelets; angiotensin–converting enzyme inhibitors; beta-blockers; and statins. At hospital discharge, all patients received written information about risk factors for CHD and reinfarction, as well as guidance on unhealthy behavior change. Some of them had undergone surgical procedures of

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revascularization – 36.59% of patients in the BST condition received primary angioplasty with stenting vs. 42.50% of patients in the UC condition; 4.88% vs. 7.50%, respectively, underwent coronary artery bypass surgery. Most of them were offered attendance at a 12 – week exercise training that included one weekly supervised session; 48.78% of patients in the BST condition and 40.00% patients in the UC condition

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underwent the training. Patients of the experimental group additionally received 10 one-hour

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the Faculty of Psychology, University of Warsaw. BST was carried out by four trained and experienced clinical psychologists who were supervised in weekly meetings by a

senior BST therapist. The sessions were guided by the manual (Rakowska, 2000) based on principles described in two books by Weakland, Watzlawick and Fish (1974) and

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Fish, Weakland, and Segal (1982).

The concept, based on cybernetics, is that psychosocial stress-related problems

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are maintained by well-intentioned but ineffective “solutions” (behaviours that aim to

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prevent the occurrence of problems or solve problems when they occur). A frequently used ineffective solution leads to an exacerbation of the problem in a vicious cycle. An

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initially small alteration of the ineffective solution may initiate a beneficial cycle, in which a less-often used ineffective solution leads to decreased intensity of the problem.

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individual sessions of BST that were delivered at the psychotherapy clinic affiliated with

The general strategy of solving psychosocial problems is to prevent people from using their problem-maintaining ineffective solutions through getting them to behave in a way opposite to the ineffective one. First, the most disruptive, stress-producing problem and the problem-maintaining behaviors were identified by the patient. Then the behavior that is opposite to the patient’s problem-maintaining behavior was identified by the therapist. (This opposite behavior has the potential to prevent a patient from using his

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problem-maintaining behavior). A goal of therapy was identified by the therapist by asking the patient what would be the first sign of improvement. Next, patients were asked to behave in ways opposite to their problem-maintaining behaviors to block their problem–maintaining behavior. Typically, these assignments were presented as homework assignments. From the patients’ point of view, they were asked to behave in a

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counter-intuitive way. If such behavior was seen by a patient as unacceptable, then the technique of reframing was used. The therapist, utilizing the patient’s beliefs, convinced

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case of patients with high levels of resistance about being influenced, a paradoxical

intention was applied. They were asked by the therapists to continue their problematic behavior or their problem–maintaining behavior, in hope that they would choose to do the opposite of what was requested. When a patient’s problem was solved, the therapist

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used relapse techniques to prevent recurrence of the problem. These techniques have three goals. First, attributing a positive meaning to the temporary problem recurrence,

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so as to mitigate the patient’s fear of losing an improvement (such fearful expectancy

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might lead the patient to use the problem–maintaining behavior again, which could produce the problem again). Second, understanding that using the problem–maintaining

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behavior again would produce the problem again, so that the patient has a sense of control over the problem. Third, recognizing that the patient owes the problem solution to their own effort, to increase the patient’s confidence in handling personal problems in

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the patient that this counter-intuitive approach makes sense and would be beneficial. In

the future.

Adherence to the Study Intervention Protocol adherence of the BST was assessed by using the Brief Strategic Therapy Skills Scale. Its items assessed (1) selecting the most bothersome problem, (2) the key problem-maintaining behavior, (3) defining the first sign of improvement – a goal

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of therapy, (4) identifying patient’s beliefs about his/her problem and therapy, (5) planning strategy for change, (6) application of strategic therapy techniques, (7) quality of homework assigned, and (8) incorporating tactics for termination of therapy. Two clinical psychologists heard audiotapes of the 2nd, 7th and 10th sessions of 10 randomly selected patients from the sample subjected to BST, and rated therapists’

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adherence to protocol on Likert-type 5-point scales. The intraclass correlation

coefficient was calculated on the total scores of 8 items of the Brief Strategic Therapy

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was .64 for the mean of 8 items, which was statistically significant F (8.79) = 17.56, p< .001.

1.1.4.8 Procedure

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The research procedures were approved by the University of Warsaw human research ethics committee.

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Participants were recruited from among in-patients who were hospitalized for a first non-fatal MI in the cardiology ward of the Military Institute of Medicine in Warsaw. The

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hospital treats patients from various backgrounds, not only military veterans. Diagnoses of a non-fatal MI (ICD-10 code 121; WHO, 1994) were defined by the admission

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electrocardiogram, hospital acute electrocardiograms, and cardiac enzymes. In order to select patients with increased levels of stress associated with psychosocial

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Skills Scale. Interrater reliability was satisfactory; the intraclass correlation coefficient

risk factors for a MI, the Checklist of Psychosocial Risk Factors for Coronary Heart Disease was used. It encompasses 14 stressors indicated by research literature (Rozanski et al., 2005)

as risk factors for a MI and CHD. These are (1) social isolation, (2) lack of quality social support, (3) adverse life events such as marital conflict or dissatisfaction, family conflicts, economic deprivation and conflicts at work, (4) work-related stressors (job control, demands and strain), (5) experiencing negative emotions (anxiety, anger and depression), (6) chronic

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worry about the consequences of a MI. Subjects were asked to rate the intensity of nervous tension associated with the particular stressors during the last month on a 5-point Likert-type scale, where “0” indicated no level of nervous tension and “4” indicated a very considerable level of nervous tension. The reliability of the instrument was adequate; the internal consistency alpha coefficient was.89. Intensity of nervous tension at levels of 4 or 3 on the 0 -

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4-point scales associated with at least one of the 14 stressors on the list was the cut-off for inclusion. Individuals with intensity ratings of 2 or 1 were excluded. As a result, those

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of the 14 stressors from the list.

Of 178 patients approached, 98 were qualified as having increased levels of stress associated with at least one psychosocial risk factor for a MI. They were invited for an interview-based assessment of their clinical (mental and physical) status. The data were

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obtained through assessment instruments and structured interviews. The instruments’

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reliabilities were found to be adequate; the internal consistency alpha coefficients ranged from .89 to 91. Diagnoses of DSM-IV Axis I disorders were made by two investigators, using a

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modified structured clinical interview for DSM–IV (Di Nardo, Brown, & Barlow, 1994). The diagnostic criteria of mental disorders due to acute MI according to DSM-IV (APA, 1994)

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were added to these interviews. There were 18 diagnoses made of mixed anxiety–depression disorder, 11 of chronic adjustment disorder with anxiety, 8 diagnoses of generalized anxiety

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included were characterized by high or moderate levels of stress associated with one or more

disorder, 3 of PTSD, 3 of generalized anxiety disorder with acute stress disorder, 3 of substance–related disorder, 2 of generalized anxiety disorder with mild depressive disorder, 1 of cyclothymic disorder. Interrater reliability indices for diagnoses were moderate to high (κ’s

from .68 to .89). Three candidates were excluded for alcohol dependence, and 1 for psychotic disorder.

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Trial conditions were discussed with 95 candidates. They were told that two forms of cardiac rehabilitation were used in the trial and that each was judged by experts to be effective for long-term recovery, and that the progress of MI patients’ recovery was followed during the trial to understand this process better. Fourteen candidates did not want to participate in the study. The main reasons for refusing to participate were “feeling too ill”, “too many

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family responsibilities”, or “travel distance”. Those who decided to take part in the study signed a written informed consent form outlining the study procedures. The consent included

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appointments, and if contacting them or their families was not possible, contacting their

hospital or other hospitals to assess survival status. Eighty one patients were finally included in the study (the Appendix illustrates the flow of participants through the study). A random number table was used to create group assignments. The outcome of the

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randomization was put in a sealed envelope, and patients who were admitted to the current

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study received these envelopes after the baseline interview. The comparison groups were balanced in terms of demographic and clinical

Table1.

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Table1

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characteristics at intake. Patients’ demographic and clinical characteristics are shown in

The time between the baseline assessment and the start of BST intervention was 50

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allowing researchers to contact patients or their families if they failed to keep assessment

days. Treatment was planned with a delay, not in the immediate wake of the MI, so as to not interfere in the participants’ natural recovery process. The evidence shows that in the early

phases of an acute stress experience, strategies involving avoidant tactics work best to reduce pain, stress, and anxiety, while approach coping is more efficacious in later phases of the stress experience (Suls &Flechter, 1985). Early intervention could contribute to giving up avoidance coping with stress prematurely.

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A pair of investigators, blind to condition, conducted outcome assessments. Outcomes were assessed before treatment, at post-treatment (10 weeks from treatment start) and at follow-ups (1 and 2.5 years after treatment termination). Patients were asked to fill in questionnaires on perceived stress and health status, and those who had been or were hospitalized were asked to present a hospital discharge form with a written diagnosis. Before

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outcome interview dates, participants were contacted by a person in charge of arranging the interviews to arrange suitable dates. They were offered a choice of places for the interview, so

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psychotherapy clinic, or the hospital where they were recruited for the current study – all

three were located in different parts of the city. If any of the participants could not come for an interview in person, the researcher offered to come to his/her home for an interview, or it would be arranged by mail, depending on whether the patient was hospitalized between the

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interviews, and whether there was a need to check out the diagnosis on his/her hospital discharge form.

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1.1.4.9 Outcome Assessments

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The Perceived Stress Scale (PSS-10) was used (Cohen & Kamrack Mermelstein, 1983). This is a 10-item self-report instrument for measuring the feelings and thoughts reflecting current

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levels of experienced stress. Its items tap how unpredictable, uncontrollable, and overloaded respondents find their lives. It includes a number of direct queries about feeling overwhelmed

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it would be easy for them to get to. The options were the Psychology Faculty, the

by difficulties, feeling not being able to control important things, and not having confidence

in handling personal problems. Respondents were asked to rate how often they felt in a certain way during the last month on 5-point Likert-type scales, where “0” means never and “4” means very frequently. Item responses were summed to create a composite score. Higher scores reflect greater stress. Internal consistency and construct validity of this scale have been documented (Cohen et al., 1983).

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Reinfarction and mortality rates in subjects of the current study were determined on the basis of diagnoses written in patients’ hospital discharge cards and in a hospital discharge registry. Re-hospitalizations were monitored according to an agreement established with patients in written consent before the study began. Before assessment interviews at midtreatment, post-treatment and at follow-ups, patients were contacted by a person in charge of

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arranging assessment interviews to arrange suitable dates. They were reminded that if they were hospitalized in the period between interviews, they would be asked to present a hospital

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diagnosis was. In this way it was determined if these patients had had a second MI. If any

patients could not be reached before assessment appointments, their families were contacted. If the families reported that these patients had died and indicated the hospital where it occurred, the discharge registry of that hospital was checked to confirm that these patients had

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died and for what reason, and it was determined if these patients had died from fatal

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reinfarction.

The SF-36 Health Survey (SF-36) was used (Ware, Snow, Kosinski, & Gondek,

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1993). This is a 36-item self-report survey that measures eight domains of health. Factor analytic studies have confirmed physical and mental health factors. The Physical

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Component Summary measure includes: physical functioning, role limitation due to physical function, bodily pain, and general health perception. The Mental Component Summary

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discharge form with a written diagnosis during the interview to inform researchers what the

measure includes: vitality, social functioning, role limitation due to emotional problems, and mental health. Subjects were asked to assess their health status during the last month. The SF

-36 measure was scored on scales of 0 to 100, with higher scores indicating better health. In the current study, two composite scores were used. The reliability and validity of this instrument have been documented (Ware, Kosinski, & Dewey, 2000).

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1.1.4.10 Statistical Analyses All analyses were based on intention-to-treat approach principles. Scores of all patients were included in the analyses. Missing scores were replaced by the last observed score. To examine differences between the BST and the UC groups on continuous outcome variables, Student’s t-tests for independent samples were performed. To examine differences

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between the BST and UC groups on categorical outcome variables, Fisher’s exact tests were performed.

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groups with the use of inferential statistics, descriptive statistics that convey the estimated

magnitude of change were used. To evaluate the magnitude of change for the BST condition as compared to the UC condition for continuous outcome scores, Cohen's d was used. It was

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calculated as the difference between the means of the experimental and control groups divided by the standard deviation of the pooled sample of both groups (Cohen, 1988). To evaluate the

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magnitude of change for the BST as compared to UC for categorical outcome scores, a relative risk measure was used. It was calculated as the ratio of the probability of an event in

Bell, 2013).

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the experimental group divided by the probability of the event in the control group (Olivier,

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To assess how many individuals in the BST and UC conditions reached a magnitude

of change on continuous outcome variables that should be practically meaningful for them,

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To complement the examination of differences between experimental and control

the reliable change index (Jacobson & Truax, 1991) was applied. A patient was considered

significantly improved when the standardized difference between two assessments, corrected for the reliability of the measure, equaled or exceeded a z-score of 1.96 (p < .05). The differences between numbers of patients who reached clinically significant change on continuous outcome measures in the experimental and the control conditions were tested for statistical significance by Fisher’s exact tests.

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1.1.4.11 RESULTS Attrition and Attendance No differences were found in attrition rates between subjects in the two treatment conditions at post-treatment or follow-ups. Of the 81 patients entering the study, two patients (5%) of the BST group and one (3%) of the UC control group withdrew before completion of treatment.

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At 1-year follow-up, one additional patient (3%) of the BST group and no further patients

(0%) of the UC control group withdrew from the study. At 2.5-year follow-up, one additional

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withdrew from the study. Attendance at the BST sessions was excellent. 32 patients had

perfect attendance, 5 patients did not appear at 1 of 10 sessions. The two who terminated early gave up after the fourth and fifth sessions.

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Outcome Analyses

The t-tests with continuous pretreatment outcome scores indicated that there were no

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significant differences between groups of patients in the BST and UC conditions. Pretreatment scores are presented in Table 2

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To examine differences between the BST and the UC groups, t-tests were performed

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on the three continuous outcome measures and Fisher’s exact tests were performed on the two categorical outcome variables. The results are shown in Table 2. The analyses revealed that the BST participants as compared to the UC participants showed a significantly greater

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patient (3%) in the BST condition and one additional patient (3%) in the UC condition

reduction in perceived stress at post-treatment, and this reduction was maintained by them at follow-ups. They also showed a significantly greater improvement in mental health at post-

treatment, and this improvement was maintained by them at follow-ups. There were no statistically significant differences between participants in the BST and the UC groups in physical health at post-treatment, while there were statistically significant differences between them at follow-ups. Those of the BST group had improved physical health to a greater degree.

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They also had a significantly lower rate of non-fatal reinfarctions at 1-year follow-up and significantly lower rate of fatal reinfarctions at 2.5-year follow-up. To get a clearer impression of the magnitude of changes associated with the BST treatment condition, effect sizes were calculated. Effect size is the magnitude of the difference between groups reflecting the magnitude of change. Table 2 shows the data. For continuous

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outcome measures, Cohen’s d was used. A threefold classification of effect sizes: small (.20.49), medium (.50-.79), and large (.80 and above) has been proposed. A comparison of the

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in perceived stress at post-treatment and at follow-ups. Cohen’s d values were also large for increases in mental health at post-treatment and at follow-ups. For an increase in physical

health at post-treatment there was none effect, while for increases in physical health at followups effect sizes were medium. For categorical outcome measures, a relative risk measure was

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used. A relative risk below 1 means that an event is less likely to occur in the experimental

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group than in the control group; a relative risk above 1 means the event is more likely to occur in the experimental group than in the control group; a relative risk of 1 means there is no

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difference in risk between the two groups. A threefold classification of relative risk sizes: small (above .82 - .53), medium (.54 - .32), and large (.33 – and below) has been proposed. A

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comparison of the BST and UC groups revealed that for the BST condition effect sizes were large for lower non-fatal reinfarction rate at 1-year follow-up and for lower fatal reinfarction

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BST and UC groups revealed that for the BST condition effect sizes were large for decreases

rate at 2.5-year follow-up.

Table 2

To address the extent to which individual patients in the BST and UC conditions

reached a magnitude of change that should be practically meaningful for them, the data were analyzed in terms of the percentage of patients who reached clinically significant change. As can be seen in Table 3, the BST condition was significantly superior to the UC in percentage of patients who reached a clinically significant reduction in perceived stress at post-treatment

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and maintained this reduction at follow-ups. The BST condition was also superior in terms of the percentage of patients who reached a clinically significant improvement in mental and physical health at post-treatment and maintained this improvement at follow-ups. Table 3

1.1.4.12 DISCUSSION

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Effectiveness of BST

The primary purpose of this investigation was to determine whether BST in a dose of 10 hour-

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UC, as compared to UC alone, would contribute to perceived stress reduction and would have an impact on clinical outcomes in first MI patients with increased levels of stress. The results of analyses provided support for the usefulness of BST in reducing sustained perceived stress (58.5% vs. 5.0%) as well as in improving sustained mental health (58.5% vs. 5.0%). More

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patients in the BST condition than in the UC condition had improved sustained physical

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health (48.8% vs. 25.0%). The results of analyses provided also support for the usefulness of BST in contributing to lower non-fatal reinfarction rate (2.5% vs. 17.5%), and subsequent

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lower fatal reinfarction rate (2.5% vs. 15.0%). A second non-fatal MI occurred in one (2.5%) patient of the BST group at 1-year follow-up; that patient died at 2.5-year follow-up from a

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fatal MI. Seven (17.5%) patients of the UC group had a second non-fatal MI at 1-year followup, of these six died from a fatal MI at 2.5-year follow-up.

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long individual sessions aimed at psychosocial stress-related problems in conjunction with

According to guidelines applied in the current study (Cohen, 1988), the effect size

was large for the BST group for sustained stress reduction, and sustained improvement in mental health. The effect size was medium for the BST group for sustained improvement in physical health. This suggests that these changes in the BST participants were substantial

enough to have practical significance. However, there is no agreement on what magnitude of effect is necessary to establish practical significance and how to interpret effect sizes. For

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instance, Ferguson (2009) suggests that for effect size estimates based on group differences in the social sciences, a value of .41 is the minimum effect size for representing a practically significant effect; a moderate effect is determined by the value of 1.15; and a strong effect by the value of 2.70. According to these criteria, which are more conservative than those used in the current study, effect sizes for the BST condition were moderate for sustained stress

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reduction and mental health improvement, while the effect size for having practical value for sustained physical health improvement was minimal. Similarly, Ferguson suggests that for

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minimum effect size for representing a practically significant effect; a moderate effect is

determined by the value of 3.0 (0.33, respectively); and a strong effect by the value 4.0 (0.25, respectively). According to these criteria, which are also more conservative than those used in the current study (Olivier, Bell, 2013), relative risk for the BST condition was strong for non-

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fatal and subsequent fatal reinfarction rates at follow-ups. However, this result should be

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interpreted cautiously in the context of the limitations of the study, which are described in the Limitations of the Study section.

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Psychological Interventions in Selected MI Patients Three previous randomized controlled trials comparing the effectiveness of cognitive-

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behavioral or behavioral interventions in conjunction with medical treatment to medical treatment alone in MI patients with emotional problems, and using reinfarction and sudden

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effect sizes based on risk estimates, a value of 2.0 (0.5 for risk of negative event) is the

cardiac death as endpoints, yielded mixed results. Cognitive–behavioral interventions (cognitive restructuring, relaxation, homework) were effective for patients with type A personality behavior (Friedman, Thoresen, & Gill, 1986), while were not for patients with

depression (73%) or social isolation or both (Berkman, Blumenthal, & Burg, 2003). Behavioral interventions (relaxation, homework) were not effective for patients with anxiety or depression or both (Stern, Gorman, Kaslow, 1983). The study mentioned above including

17

MI patients with depression or social isolation or both, using a self-rated generic health status measure, showed an improvement in their mental but not their physical functioning (Berkman et al., 2003). Results of the current study can be related to the results of the study including MI patients with type A personality behaviors. Both MI populations can be characterized as

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having increased levels of stress, though for different reasons. Type A personality behaviors are thought to be manifestation of specific way of coping with stress, which means that these

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though they do not have any impact on them, since they cannot be changed (Matthews, Glass, Rosenman, & Bortner, 1997). Evidence has confirmed that two behaviors—competitive drive and impatience—are associated with the incidence of coronary heart disease. Relation to Other Findings

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The results of the current study can be explained from the viewpoint of research literature on

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the impact of mental stress on the pathogenesis of coronary heart disease as well as acute coronary syndromes and sudden cardiac death.

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First, mental stress influences the development of coronary heart disease through the evolution of atherosclerosis (directly through neuroendocrine mechanisms or indirectly

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through production of unhealthy behaviors which in turn influence the metabolic syndrome) (Chandola, 2009). In light of these findings, it can be hypothesized that the progression of the

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people struggle to maintain control over events that they assess as potentially harmful even

underlying, stress-promoted, atherosclerotic processes might have been stabilized, slowed, or reversed in the 24 participants in the BST condition and in 2 participants in the UC condition

who reached a clinically significant reduction in stress. Of the 24 participants in the BST condition who reached a clinically significant stress reduction, 20 also reached a clinically significant improvement in self-rated physical health. This means that these 20 participants might have stopped the atherosclerotic processes through both a stress reduction and medical

18

treatment. Of the 10 participants in the UC condition who reached a clinically significant improvement in self–rated physical health, 2 also reached a clinically significant stress reduction. This means that these 2 might have stopped the atherosclerotic processes through both stress reduction and medical treatment, while in the other eight it could have been blocked only by medical treatment.

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Second, an exaggerated cardiovascular response to mental stress (increases in systemic vascular resistance, coronary artery vasoconstriction, and microvascular changes) is

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syndromes and sudden cardiac death in persons with advanced atherosclerosis who are vulnerable to stress (Strike & Steptoe, 2003). High emotional responsivity (defined as

substantial self-reported emotional tension levels) is associated with an increased likelihood of exhibiting myocardial ischemia in response to mental stress in both the laboratory and in

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real-world settings (Carels et al., 1999), and can be seen as vulnerability to stress. Ischemia

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induced by mental stress and ambulatory ischemia can both be reduced by stress management (James et al., 1997), which suggests that ischemia can be decreased by stress reduction. In

pt

light of these findings, it can be hypothesized that the 6 participants in the UC condition and one in the BST condition who had reinfarction and fatal reinfarction might have had advanced

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atherosclerosis and might have been vulnerable to acute stress. They reported high nervous tension levels in connection with more than one stressor (4 on 0-4 scales on the Checklist of

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associated with the occurrence of myocardial ischemia, and predicts acute coronary

Psychosocial Risk Factors for Coronary Heart Disease), none of them reached a clinically significant chronic stress reduction (PSS-10), nor a clinically significant improvement in selfrated mental and physical health (SF-36). In their case, experiencing considerable acute stress

in response to stressors might have induced an exaggerated cardiovascular response which promoted myocardial ischemia and thus triggered non-fatal and subsequent fatal reinfarction. Other studies have shown that in patients with increased levels of stress the occurrence of

19

reinfarction and sudden cardiac death is independent of age (Arnold et al., 2012; FrasureSmith, 1991), increased depression symptoms, previous infarction, revascularization status (Arnold et al., 2012), or a history of coronary heart disease (Frasure-Smith, 1991). These results explain the young age of participants who died. In the case of the 24 participants in the BST condition and the 2 in the UC condition

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who reached a clinically significant reduction in chronic stress, it can be hypothesized that at pre-study they might have had advanced atherosclerosis and might have been vulnerable to

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stressor: 4 on 0-4 scales on the Checklist of Psychosocial Risk Factors for Coronary Heart Disease). They might have attenuated an exaggerated cardiovascular response induced by

acute stress, which promotes myocardial ischemia, and this might have prevented them from the occurrence of acute coronary syndromes and sudden cardiac death. They could have

Limitations of the Study

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reached such a change by improving their skills of coping with stress.

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The following limitations of this study are acknowledged. Participants’ cardiac function was

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not controlled with objective indices - left ventricular ejection fraction, and inducible ischemia. The presence of inducible ischemia (Gehi et al., 2008) and indices of left ventricular

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systolic dysfunction (Quintana et al., 2004) are both valuable in predicting reinfarction and sudden cardiac death after MI. Without such information, it is unknown whether participants

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acute stress (they reported high nervous tension level in connection with more than one

with cardiac dysfunctions were evenly distributed in the BST and UC conditions. Such knowledge would enable attributing low reinfarction and fatal reinfarction rates among patients in the BST condition entirely to BST interventions. It would also reveal whether cardiac dysfunctions were the reason for high reinfarction and fatal reinfarction rates among patients in the UC condition. The lack of such information limits valid generalizations about

the effectiveness of BST in preventing MI patients with increased levels of chronic stress

20

from morbidity and mortality. Similarly, vulnerability to acute stress among participants was not controlled. Such information would enable us to understand to what extent MI patients with increased levels of chronic stress in the current study were characterized by vulnerability to acute stress (defined as high level of emotional responsivity) and whether they benefited from BST or not.

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Generalizability of Findings The concept of generalizability of findings has two aspects. First, generalizing to a

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which the sample was selected. Second, generalizing to a theory, which deals with moving from observations to scientific theories or hypotheses.

Generalizability to the population of MI patients is limited to the subgroup of MI patients in this study. These were men and women with increased levels of stress, aged 40–65

M

years, with a first MI diagnoses. In addition, they perceived psychosocial problems as being

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risk factors for CHD and were willing to receive professional help to control them. They did not have severe somatic co-morbidity (e.g., kidney insufficiency, fibromyalgia, chronic

pt

fatigue), or severe mental co-morbidity (e.g., substance dependence–related disorders, or psychotic disorders). Moreover, the age range of participants, who were in their productive

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years, was associated with their motivation to attend psychotherapy based on a need to keep a job in order to continue a career or support a family.

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population, which means applying results from a study sample to the larger population from

Increased levels of chronic stress at pre-study and age under 65 years are the most

relevant characteristics of the current study population, and results from this study sample should be applied to the larger population with these characteristics. Participants’ PSS-10 scores at pre-study were higher than norms for the mentally and physically healthy population (24.54 vs. 13.2) (Cohen & Williamson, 1988). Their scores in all eight SF-36 domains at prestudy were lower than norms (sex-adjusted Oxford norms; Jenkinson et al., 1993) for people

21

under 65. In mental health domains, large differences were observed in social functioning (60.85 vs. 87.54), role limitation due to mental functioning (58.89 vs. 85.11), and smaller differences in vitality (53.34 vs. 62.01). In physical health domains, large differences were observed in physical functioning (60.02 vs. 82.00), role limitation due to physical functioning (56.83 vs. 77.64), pain (60.04 vs. 79.16), and smaller differences in general health (59.62 vs.

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68.32). Having lower than normative scores in eight SF-36 domains seems to be a common characteristic for MI patients under 65. Unselected MI patients aged under 65 also exhibited

community norms (Brawn et al., 1999).

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under 65, while those aged over 65 did not. Scores of those patients were similar to

The homogeneity of participants in respect of increased levels of stress and ages under 65 influenced results of the current study. It contributed to finding substantial effects of

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BST for sustained stress reduction and improvement in mental and physical health.

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These effects were a result of low variability of the scores between participants (standard deviation) at pre-study, and large differences between the BST and UC groups. First, high

pt

scores of PSS-10 and low scores of SF-36 in mental and physical domains in participants at pre-therapy were homogeneous. This means little variability within these scores between

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participants at pre-study, which was reflected in low standard deviations. Low variability of scores between subjects at pre-study contributed to finding robust effects for BST. This was

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impairment in all eight SF-36 health domains as compared to norms for the normal population

the result of referring mean differences between the BST and UC groups at mid-, post–study and follow-ups to low variability of scores between participants at pre-study. With low standard deviation of the scores at pre-study, it was easy for the value of differences between the groups to exceed the value of individual differences between participants at pre-study and find a large effect. Second, scores of PSS-10 being high and scores of SF-36 in mental and

physical domains being low at pre-therapy contributed to large differences between the scores

22

within the BST group and between the BST and UC groups, and thus to finding large effects for BST. The rate of fatal reinfarction in participants of both treatment conditions (17.5%) was higher than rate of total mortality in unselected MI survivors under 65 years after four years from a MI (16%) (Brown et al., 1999). However, it was lower than rate of total

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mortality in unselected MI patients over 65 years (42%) (Brown et al., 1999). Participants of the current study as compared to these unselected MI patients under 65 years (Brown et al.,

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health domains such as social functioning (60.85 vs. 72.00), role limitation due to emotional

functioning (58.89 vs. 71.00), and mental health (53.39 vs. 68.56). The rate of death closer to the rate of younger age ranges, and the co-occurrence of impairment in mental health with a high death rate in participants of the current study, support the idea that the results of the

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current study can be generalized to a MI population under 65 years with impairments in

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mental health.

What scientific theory could the results of the current study be generalized to? The

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observations from the current study can be generalized into evidence-based knowledge: “brief strategic therapy causes a decrease in chronic stress levels and by that contributes to self-rated

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health improvement.” To increase our confidence in the generalizability of the study result, it would have to be repeated with the same psychotherapy method but with different providers

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1999) exhibited greater impairment in mental health. They had lower scores in SF-36 mental

in different settings and yield the same results. Can the observations from the current study be generalized into the statement: “brief strategic therapy causes a decrease in chronic stress

levels and by that prevents reinfarction and sudden cardiac death?” To increase our confidence in the generalizability of this study result, it would have to be repeated with the same psychotherapy method, but with different providers in different settings, controlling for even distribution of participants with cardiac dysfunctions that predict reinfarction and sudden

23

cardiac death (such as inducible ischemia and left ventricular systolic dysfunction) in the BST and UC conditions, and yield the same results. Conclusions The current study provided evidence that the disease course after myocardial infarction is influenced favorably in the short- and long-term by giving brief strategic therapy in addition

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to usual medical care in patients with increased levels of perceived stress. Thus its findings indicate that interventions targeting chronic stress levels and coping with stress in the MI

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increased stress. They also imply that it is important to consider patients’ perceived stress levels when evaluating their risk for poor long–term outcomes. Nevertheless, further

exploration is needed to determine the mechanisms through which psychological intervention

ACKNOWLEDGEMENTS

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may be beneficial for those with increased stress levels.

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The study was supported by grant nr. 144525/2009 for statutory research from the Faculty of Psychology, University of Warsaw.

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This study was given organizational support by the late professor Leszek Kubik, head of the

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cardiology ward of the Military Institute of Medicine in Warsaw.

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population may attenuate increased morbidity and mortality and poor health status risk from

24

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Ware, J.E, Kosinski, M., Dewey, J.E (2000). How to score version two of the SF -36

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Table 1 Sample demographic and clinical characteristics by treatment condition N

%

N

%

Significance p level a Two-tailed

24/17

58/42

25/15

62/38

.821

Higher education

16

39

16

40

.999

Secondary education

17

41

15

38

.821

Characteristics

BST N =41

Form for personal particulars Male/female

8

19

9

22

.790

Married or cohabitating/without partner

31/10

76/24

33/7

83/17

.446

M

SD

M

SD

Age

53.56

4.58

53.40

4.27

Checklist of Physiological Risk Factors for CHD

N

%

N

%

Hypercholesterolemia

25

61

24

60

.928

Hypertension

18

44

16

40

.722

Diabetes

6

15

3

8

.482

Excess weight

7

17

6

15

.799

Checklist of Behavioral Risk Factors for CHD

N

%

N

%

17

41

16

40

.999

7

17

6

15

.999

25

61

26

65

.819

16

39

14

35

.819

7

17

6

15

.999

High daily caloric input Inactivity Smoking Excessive alcohol consumption

Post-MI heart failure symptoms

N

%

N

%

34

83

32

80

.781

28

68

27

68

.999

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Checklist of Cardiac Symptoms Post-MI angina symptoms

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Poor diet

t79 =.16; p = .871

M

SD

M

SD

21.07

18.60

22.25

18.60

N

%

i

%

Rheumatism of hard or soft tissues

5

12

4

10

Structured Clinical Interview DSM-IV

N

%

N

%

Unspecified mixed anxiety-depressive disorder

10

24

8

20

.790

Generalized anxiety disorder

3

7

5

13

.482

Chronic adjustment disorder with anxiety

5

12

6

15

.756

ed

A previous history of CHD in months

.694

ce

pt

Checklist of Somatic Comorbidity

t79 = -.28;p =.777

PTSD 2 3 1 3 .999 Generalized anxiety disorder with acute stress 2 5 1 3 .999 disorder Generalized anxiety disorder with mild depressive 1 2 1 5 .999 disorder BST-brief strategic therapy; UC- usual care. a Probability level for Fisher's exact tests, and Student’s t tests comparing patients’ characteristics by the BST and UC conditions.

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Less than secondary education

UC N =40

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Table 2 Scores for Continuous and Categorical Outcome Measures at Pre-study, Post-Study, and Follow-ups by Treatment Condition and Effect Sizes for the BST Condition

Mental health

Non-fatal Reinfarction

M

M

SD

Cohen’s d value

95% confidence intervals

Pre-study

24.60

1.74

24.58

1.75

t79 =.052; p=.959

Post-study

22.05

b

1.94

24.71

1.79

t79 =-6.39; p=.000

1.242

1.041–1.844

Follow-up 1

22.03 b

1.93

24.67

1.78

t79 =-6.41; p=.000

1.239

1.040–1,839

Follow-up 2

22.02 b

1.93

24.69

1.76

t79 =-6.49; p=.000

1.263

1.066–1.860

Pre-study

53.30

2.32

53.49

2.22

t79 =-.37; p= .711

Post-study

58.99

b

5.83

53.21

2.29

T52.23 =5.89; p= .000

1.115

.358–2.272

Follow-up 1

58.95 b

5.90

53.19

2.31

T52.23 =5.81; p= .000

1.096

.328–2.264

Follow-up 2

58.94

T51.19 =6.01; p= .000

1.139

.375–2.304

Pre-study Post-study

5.91

53.01

2.21

58.95

2.13

59.32

1.97

t79 =-.83; p= .411

63.72

4.90

61.91

4.91

t79 =1.66; p= .101

.450

-.616–1.515

Follow-up 1

63.95

b

5.13

61.75

4.77

t79 =1.99; p= .050

.497

-.595–1.547

Follow-up 2

64.25

b

t79 =2.12; p= .037

.506

-.599–1.597

b

5.14

No.

%

Pre-study

1

2.50

Post-study

0

0

Follow-up 1

1

2.5

Follow-up 2

0

0

b

Pre-study

61.71

4.81

No.

%

0

0

0

0

7

17.5

0

0

Relative risk value

p = .999 -

-

-

0.15

0.2–1.14

-

-

-

-

-

-

p = .029 -

Post-study

0

Follow-up 1

0

Follow-up 2

1b

0

0

M

Fatal Reinfarction

UC N =40

0

0

0

0

2.50

6

15.0

p = .057

-

-

0.17

0.2–1.36

BST-brief strategic therapy; UC-usual care. Follow-up 1 -1-year follow-up; Follow-up 2 -2.5-year follow-up Probability level for Student’s t- tests and Fisher’s exact tests comparing outcome measures by the BST and UC conditions. b Significantly different from the UC group. .

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ed

a

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Physical health

SD

Significance level a Two-tailed

BST N =41

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Perceived stress

Time of Measurement

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Outcome variables

31

Table 3 Percentages of Patients who Reached Clinically Significant Improvement in Continuous Outcome Measures at Post-treatment and Follow-ups by Treatment Condition

Perceived stress

Mental health

%

No.

%

Post-study

24 b

58.5

2

5.0

001

1-year follow-up

24

b

58.5

2

5.0

.001

2.5-year follow-up

24 b

58.5

2

5.0

.001

Post-study

24

b

58.5

2

5.0

.001

1-year follow-up

24

b

58.5

2

5.0

.001

2.5-year follow-up

24 b

58.5

2

5.0

.001

Post-study

16

b

32.0

9

1-year follow-up

20

b

48.8

10

2.5-year follow-up

21 b

51.2

10

BST N =41

UC N =40

22.5

.022

25.0

.001

.001 BST-brief strategic therapy; UC-usual care . a Probability level for Fisher’s exact tests comparing numbers of participants who reached clinically significant improvement in the BST and UC conditions. b Significantly different from the UC group.

ce

pt

ed

M

an us

25.0

Ac

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Physical health

No.

Significance level a Two-tailed

Time of Measurement

cr ip t

Outcome variables

32

APPENDIX Flow diagram of participants through the study

Excluded (n = 17) Did not meet inclusion criteria (n = 4) Refused to participate (n = 13)

Assessed for eligibility (n = 98)

Enrollment

Allocated to UC (n = 40) Received UC (n = 40) Discontinued (n = 1)

Analysis of 10week treatment data

Analyzed (n = 41) Excluded from analysis (n = 0)

Analyzed (n = 40) Excluded from analysis (n = 0)

1-year follow-up

Lost to 1-year follow-up (n = 3)

Lost to 1-year follow-up (n = 1)

Analysis of 1year follow-up data

Analyzed (n = 41) Excluded from analysis (n = 0)

Analyzed (n = 40) Excluded from analysis (n = 0)

2.5-year follow-up

Lost to 2.5-year follow-up (n = 5) 1 deceased

M

an us

Allocated to BST (n = 41) Received BST (n = 41) Discontinued (n = 2)

Allocation

Analyzed (n = 40) Excluded from analysis (n = 0)

ce

pt

ed

Analysis of 2.5Analyzed (n = 41) year follow-up Excluded from analysis (n = 0) data BST-brief strategic therapy; UC –usual care

Lost to 2.5-year follow-up (n = 8) 6 deceased

Ac

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cr ip t

Randomized

33