Dialectical behavior therapy skills for transdiagnostic emotion dysregulation: a pilot randomized controlled trial.

Accepted Manuscript Dialectical Behavior Therapy Skills for Transdiagnostic Emotion Dysregulation: A Pilot Randomized Controlled Trial Andrada D. Neacsiu , Jeremy Eberle , Rachel Kramer , Taylor Wiesmann , Marsha M. Linehan PII:

S0005-7967(14)00074-6

DOI:

10.1016/j.brat.2014.05.005

Reference:

BRT 2716

To appear in:

Behaviour Research and Therapy

Received Date: 3 October 2013 Revised Date:

12 April 2014

Accepted Date: 8 May 2014

Please cite this article as: Neacsiu, A.D., Eberle, J., Kramer, R., Wiesmann, T., Linehan, M.M., Dialectical Behavior Therapy Skills for Transdiagnostic Emotion Dysregulation: A Pilot Randomized Controlled Trial, Behaviour Research and Therapy (2014), doi: 10.1016/j.brat.2014.05.005. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

ACCEPTED MANUSCRIPT Running head: TREATMENT FOR EMOTION DYSREGULATION

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Randomized Controlled Trial

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Dialectical Behavior Therapy Skills for Transdiagnostic Emotion Dysregulation: A Pilot

Andrada D. Neacsiu1,2, Jeremy Eberle2, Rachel Kramer2, Taylor Wiesmann2, and Marsha M. Linehan2 Duke University Medical Center University of Washington

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Author Note

Marsha M. Linehan receives royalties from Guilford Press for books she has written on

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dialectical behavior therapy (DBT). Marsha M. Linehan and Andrada D. Neacsiu receive fees for DBT trainings. This research was supported by an American Psychological Association Dissertation Research Award granted to the first author. Data was also presented as part of the

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first author’s doctoral dissertation and in conference talks. The authors would like to thank the therapists and clients who took part in this study and to acknowledge Megan Smith, Laura

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Murphy, Sara Miller, Annika Benedetto, William Kuo, Dan Finnegan, Kevin King, Heidi Heard, and Nancy Whitney for their contributions. We would like to thank Moria Smoski, M. Zachary Rosenthal, and Clive Robins for feedback on the manuscript. Correspondence concerning this article should be addressed to Andrada D. Neacsiu, Cognitive-Behavioral Research and Therapy Program, Duke University Medical Center (3026), 2213 Elba Street, Room 123, Durham, NC, 27710. E-mail: [email protected]

ACCEPTED MANUSCRIPT TREATMENT FOR EMOTION DYSREGULATION

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Abstract Objective: Difficulties with emotions are common across mood and anxiety disorders. Dialectical behavior therapy skills training (DBT-ST) reduces emotion dysregulation in

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borderline personality disorder (BPD). Preliminary evidence suggests that use of DBT skills mediates changes seen in BPD treatments. Therefore, we assessed DBT-ST as a stand-alone, transdiagnostic treatment for emotion dysregulation and DBT skills use as a mediator of outcome.

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Method: Forty-four anxious and/or depressed, non-BPD adults with high emotion dysregulation were randomized to 16 weeks of either DBT-ST or an activities-based support group (ASG).

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Participants completed measures of emotion dysregulation, DBT skills use, and psychopathology every 2 months through 2 months posttreatment.

Results: Longitudinal analyses indicated that DBT-ST was superior to ASG in decreasing emotion dysregulation (d = 1.86), increasing skills use (d = 1.02), and decreasing anxiety (d =

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1.37), but not depression (d = 0.73). Skills use mediated these differential changes. Participants found DBT-ST acceptable. 32% of DBT-ST and 59% of ASG participants dropped treatment. 59% of DBT-ST and 50% of ASG participants complied with the research protocol to avoid

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ancillary psychotherapy and/or medication changes. Conclusion: DBT-ST is a promising treatment for emotion dysregulation for depressed and

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anxious transdiagnostic adults, although more assessment of feasibility is needed. Keywords: dialectical behavior therapy, emotion dysregulation, transdiagnostic, anxiety, depression


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Dialectical Behavior Therapy Skills for Transdiagnostic Emotion Dysregulation: A Pilot Randomized Controlled Trial Successful psychosocial treatments exist for a large range of mental disorders; nevertheless, it is

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becoming increasingly difficult to offer clients the most effective treatment in the shortest

amount of time (Barlow, Allen, & Choate, 2004; Fava, Evins, Dorer, & Schoenfeld, 2003). One

interventions that successfully reduce them.

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potential solution to this problem is to identify transdiagnostic mental health problems and

An emerging transdiagnostic problem in need of treatment is emotion dysregulation,

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defined as lacking the skills needed or using maladaptive strategies to regulate emotional responses (Kring & Sloan, 2010; Neacsiu, Bohus, & Linehan, 2013). Difficulties with emotion regulation impede treatment (e.g., Ciarrochi & Deane, 2001; Vogel, Wade, & Hackler, 2008) and are relevant to the majority of psychological disorders. Over 85% diagnoses in the Diagnostic

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and Statistical Manual of Mental Disorders involve excesses or deficits of emotions or a lack of coherence among emotional components (Kring et al., 2010). When assessed for difficulties with emotion regulation, adults with binge-eating disorder (Whiteside et al., 2007), generalized

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anxiety disorder (GAD; Salters-Pedneault, Roemer, Tull, Rucker, & Mennin, 2006), substance use disorder (Fox, Axelrod, Paliwal, Sleeper, & Sinha, 2007), or anorexia nervosa (Harrison,

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Sullivan, Tchanturia, & Treasure, 2009) report more difficulty regulating emotions than healthy controls.

Affective disorders in particular have been strongly connected to maladaptive emotional

responses (Aldao, Nolen-Hoeksema, & Schweizer, 2010; Taylor & Liberzon, 2007), and their development and maintenance have been theoretically and empirically linked to chronic emotion dysregulation (e.g., Cisler, Olatunji, Feldner, & Forsyth, 2010; Kring & Bachorowski, 1999).


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Individuals who meet criteria for anxiety or depression report and demonstrate frequent use of maladaptive emotion regulation strategies, such as experiential avoidance, suppression, rumination, and problematic goal setting (Aldao et al., 2010; Campbell-Sills, Barlow, Brown, &

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Hofmann, 2006; Kring et al., 2010). Furthermore, participants with a mood or anxiety disorder report limited emotional clarity, fear of experiencing emotions (Campbell-Sills et al., 2006; Mennin, Heimberg, Turk, & Fresco, 2005), inappropriate emotional intensity (Etkin & Wager,

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2007), inability to modulate emotions based on contextual demands (Koole, 2009; Rottenberg, Kasch, Gross, & Gotlib, 2002), and intense reactions to nonthreatening cues (Kross, Davidson,

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Weber, & Ochsner, 2009; Schmidt & Keough, 2010). Researchers have also argued that underlying problems with affect are common in depression and anxiety (Barlow et al., 2004). Transdiagnostic treatments for problems with emotions are emerging (Ellard et al., 2010). Nevertheless, more research is needed to characterize how behavioral treatments change emotion

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dysregulation across disorders. Our aim was therefore to test an intervention designed to reduce transdiagnostic emotion dysregulation. Neacsiu, Bohus, and Linehan (2013) presented a transdiagnostic treatment model for emotion dysregulation. The model includes teaching skills

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that help the individual reduce vulnerability to emotions; manage situations that cue emotions; control attention toward or away from emotional stimuli; interpret emotional cues; manage

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biological, experiential, and action changes; and process emotions. This treatment model was derived from dialectical behavior therapy (DBT; Linehan,

1993a), an empirically supported treatment for suicide and for borderline personality disorder (BPD; for a review see Neacsiu & Linehan, 2014). DBT is based on a skills deficit model that views dysfunctional behavior as either a consequence of dysregulated emotions or a maladaptive approach to emotion regulation (Linehan, 1993a, 1993b). Consequently, DBT includes more than


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60 concrete skills (translated from behavioral research and other evidence-based treatments) that are grouped into four modules: (a) mindfulness skills, which emphasize observing, describing, and participating in the present moment effectively and without judgment; (b) emotion regulation

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skills, including strategies for changing emotions and the tendency to respond emotionally; (c) interpersonal effectiveness skills, ranging from acting assertively to maintaining self-respect; and (d) distress tolerance skills, including strategies to control impulsive actions and to radically

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accept difficult life events (Linehan, 1993b). These skills map onto the treatment model for

emotion dysregulation (Table 1), offering a comprehensive intervention for the lack of adaptive

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skills and use of maladaptive strategies that define emotion dysregulation (Neacsiu et al., 2013). Emerging evidence suggests that DBT skills training (DBT-ST) reduces problems with emotions and is feasible to implement with a variety of mental disorders. DBT-ST outperformed treatment as usual in decreasing depression in treatment-resistant individuals (Harley, Sprich,

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Safren, Jacobo, & Fava, 2008) and in decreasing depression, anxiety, and anger in a BPD sample (Soler et al., 2009). When compared to an active control condition, DBT-ST equally reduced emotion dysregulation and problems with anger, anxiety, and depression for participants

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diagnosed with eating disorders (Safer, Robinson, & Jo, 2010). Evidence also suggests that increased use of DBT skills mediates the relationship between time in treatment and changes in

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depression, anger control, and suicidal behavior across multiple treatments in BPD samples (Neacsiu, Rizvi, & Linehan, 2010). Thus, DBT skills use may be a mechanism of change for emotion dysregulation.

In the current outcome study, we pilot tested DBT-ST as a transdiagnostic intervention

for emotion dysregulation using a randomized controlled trial (RCT) designed to control for common therapy factors. We targeted non-BPD adults with high emotion dysregulation who met


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criteria for at least one anxiety or depressive disorder. We chose to target adults with clinical anxiety or depression because emotion dysregulation had been most strongly connected with depression and anxiety (see Aldao et al., 2010; Cisler et al., 2010; Kring & Bachorowski, 1999)

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and because we wanted to ensure the sample had significant clinical distress.

We had two primary aims. First, we assessed the unique effects of DBT-ST on emotion dysregulation. We hypothesized that (a) DBT-ST would reduce emotion dysregulation

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significantly more than an activities-based support group (ASG) and (b) DBT skills use will mediate the differential changes between conditions. Second, we explored (a) the unique effects

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of DBT-ST on depression and anxiety severity, (b) whether DBT skills use mediated differential changes, and (c) whether confounding effects explained any significant findings. As a supplementary aim, we also examined the feasibility of DBT-ST for a transdiagnostic sample based on (a) retention rates, (b) treatment credibility and satisfaction, and (c) compliance with

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the ancillary treatment protocol.

Method

Participants and Design

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Intent-to-treat (ITT) participants were 44 men and women from a metropolitan area in the Northwestern United States. Participants were included if they were older than 18 years of age,

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scored high in emotion dysregulation (above 96 on the Difficulties in Emotion Regulation Scale; DERS; Gratz & Roemer, 2004), and met criteria for at least one current depressive or anxiety disorder on the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I; First, Gibbon, Spitzer, Williams, & Benjamin, 1995). Participants were excluded if they scored above 2.5 on the Borderline Symptom List-23 (BSL-23; Bohus et al., 2009) or met full criteria for BPD on the Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II; First,


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Spitzer, Gibbon, Williams, 1997). Participants were also excluded if they (a) were at high risk for suicide (had attempted suicide within the past year or had current suicidal ideation with a specific plan), (b) were mandated to psychological treatment, (c) were homeless, (d) could not attend group,

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(e) had received more than five sessions of outpatient DBT, (f) could not communicate in English, (g) met criteria for bipolar or a psychotic disorder, (h) had a verbal IQ less than 70 on the Peabody Picture Vocabulary Test-Revised (PPVT-R; Dunn, 1981), or (i) met criteria for a life-threatening

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disorder (e.g., severe anorexia). To be included, participants had to verbally agree to remain on the same dosage (if any) of psychotropic medication and to refrain from participating in ancillary

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psychotherapy. The University of Washington (UW) Institutional Review Board (IRB) approved all research procedures.

Screening. To recruit participants, we distributed study flyers and brochures in the community and contacted clinicians to offer the study as a potential low-cost referral. We

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screened 406 participants by phone and further screened qualified participants in-person. Fifty seven participants met all eligibility criteria (Figure 1). The DERS cutoff was set at one standard deviation above the pooled grand mean for control samples (GM = 77.33, pSD = 19.52) in

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experimental studies published before July 2010. These samples had 1,365 total participants who (a) did not meet criteria for any disorder (Fox et al., 2007; Harrison et al., 2009), (b) did not meet

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criteria for the disorder of interest in the study (Salters-Pedneault et al., 2006; Whiteside et al., 2007), or (c) were from the general population (Cohn, Jakupcak, Seibert, Hildebrandt, & Zeichner, 2010; Gratz et al., 2004). Four assessors who were blind to treatment assignment and trained to reliability with the

UW Behavioral Research and Therapy Clinics gold standard conducted in-person interviews. Interrater reliability for 20% of SCID-I interviews (14/67) was moderate to outstanding (κ


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range: .44-1.00; Landis & Koch, 1977). The only diagnosis with low reliability was specific phobia. All other diagnoses had acceptable reliabilities ( > .60). To improve reliability, a different assessor subsequently coded all remaining ITT SCID-I interviews. Discrepancies were

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resolved through discussion with the first author, leading to 100% agreement. Interrater

reliability for 20% of SCID-II-BPD interviews (19/91) was outstanding (κ = .88, SD = .11). Power and randomization. We determined sample size based on power analyses aimed

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at detecting longitudinal emotion dysregulation differences between conditions. Data from a recently completed RCT and a published RCT suggested that we could expect an effect size ranging

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from 0.89 to 1.53 (Linehan, 2013; Gratz & Gunderson, 2006). We conducted power analyses in Optimal Design (Raudenbush & Liu, 2011), a software package designed for hierarchical linear modeling (HLM). In HLM, a slope is created for each participant completing at least one assessment time point. The differences between these slopes (nested within conditions) are

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subsequently analyzed. An HLM power analysis helps determine how many individual slopes are needed to detect the expected effect size. Our power analysis indicated that, to reach 80% power with an effect size of .89, 42 participants would need to complete the DERS at least once.

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We therefore recruited 48 participants, allowing for a 10% loss of data (from participants who did not complete any assessments). Using a minimization randomization algorithm (Pocock &

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Simon, 1975) to match participants on gender, primary diagnosis (depressive/anxiety disorder), and psychotropic medication use (present/absent), we assigned the 48 participants equally to either DBT-ST or ASG. Four participants withdrew before treatment started and did not complete any assessment, leaving 44 participants for ITT analyses (Figure 1). Assessment schedule. Treatment and data collection occurred between November 2010 and January 2012. Assessments were conducted (a) at pretreatment, (b) after 2 months, (c) at the


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end of treatment, and (d) at a 2-month follow-up. Participants completed brief interviews and self-reports measuring skills use, emotion dysregulation, psychopathology, feasibility, and confounding factors at each assessment period, except where noted below. Participants received

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up to $100 in compensation for completing all the study assessments. Outcome Measures

DERS (Gratz et al., 2004). The DERS, our primary outcome measure, is a 36-item self-

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report of six facets of emotion dysregulation: (a) nonacceptance of negative emotions, (b)

difficulty (b) pursuing goal-directed behaviors and (c) lack of impulse control in emotional

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situations, (d) lack of regulation strategies, and problems with emotional (e) awareness and (f) clarity. The DERS has adequate internal consistency (α = .93), test-retest reliability (r = .88), and construct and predictive validity. Internal consistency at screening was acceptable (α = .82). DBT Ways of Coping Checklist (DBT-WCCL; Neacsiu, Rizvi, Vitaliano, Lynch, &

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Linehan, 2010). The DBT-WCCL is a 59-item self-report of the frequency of adaptive and maladaptive skills used to manage difficult situations over the past month. We used only the DBT Skills Subscale (DSS), which includes general descriptions of skillful behavior without

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using DBT-specific language. In several BPD samples, the DSS had excellent internal consistency (α = .92-.96), good test-retest reliability (r = .71), and evidence for criterion validity

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(Neacsiu et al., 2010). In the present study, internal consistency at pretreatment was high (α = .86).

Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001). Given

that some established measures of depression (e.g., Beck Depression Inventory; BDI; Beck, Steer, & Brown, 1996; the Hamilton Depression Rating Scale; HAM-D; Hamilton, 1960) are not free for clinicians and that recent findings have led to questions about the accuracy of established


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measures (e.g., Bagby, Ryder, Schuller, & Marshall, 2004), we used the PHQ-9, a newer measure that is easy to administer, psychometrically strong, and clinician friendly. The PHQ-9 is a 9-item self-report that is sensitive to clinical change and that closely resembles DSM criteria.

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The PHQ-9 has shown good test-retest reliability (r = .84) over 2 days, and a cutoff of 9 had high sensitivity and specificity in identifying major depressive disorder (MDD; Millan, Gilbody, & Richards, 2010).

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A growing body of evidence supports that the PHQ-9 has validity and reliability

comparable to more established clinical assessments of depression such as the BDI or the HAM-

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D. The PHQ-9 is strongly correlated with both measures (e.g., rBDI-II = .84, Dum, Pickren, Sobell, & Sobell, 2008; rHAM-D = .79, Cameron et al., 2011), is equally responsive to change as the BDI (Titov et al., 2011), and is recommended over the BDI-II (Titov et al., 2011). Both the PHQ-9 and the BDI-II tend to overestimate depression severity when compared with the HAM-D

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(Cameron et al., 2011). Internal consistency at pretreatment was good (α = .74). Overall Anxiety Severity and Impairment Scale (OASIS; Norman, Hami-Cissell, Means-Christensen, & Stein, 2006). Using a similar rationale as for depression, we identified a

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free, easy-to-interpret, psychometrically strong self-report for anxiety severity. The OASIS is a 5-item measure of general anxiety over the past week with strong test-retest reliability (r = .82),

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strong convergent and discriminant validity, good internal consistency (α = .80), and adequate sensitivity and specificity. In one study, a cutoff of 7 on the OASIS correctly classified 87% of patients with an anxiety disorder, and scores did not significantly vary with the anxiety disorder identified as most distressing (Campbell-Sills et al., 2009). Other research also supports this cutoff (e.g., Norman et al., 2011). Internal consistency in the present study at pretreatment was acceptable (α = .79).


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Confound and Feasibility Measures Brief Treatment History Interview (B-THI). The B-THI is a short version of the Treatment History Interview (Linehan & Heard, 1987) that contains face-valid questions about

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treatments received in the past 2 months. Use of psychotropic medication and receipt of ancillary psychotherapy (each yes/no) were tested as confounds.

Addiction Severity Index Self-Report Form (ASI-SR). The ASI-SR is a self-report

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version of the ASI (McLellan et al., 1992). A subsection of the ASI-SR was used to assess illicit drug use over the previous month, which was tested as a confound.

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Credibility and Expectancy of Improvement Scales (CEIS). Treatment credibility and satisfaction was assessed with an adaptation of Borkovec and Nau’s (1972) scale. Participants reported on a 9-point scale how logical the treatment seemed (1 item), how successfully it would reduce their anxiety and/or depression (2 items), and how confidently they would recommend it

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to a friend (2 items). Expectancy of improvement (Borkovec & Mathews, 1998) in anxiety and/or depression was assessed with two items on a 0-100% scale. Credibility and expectancy after the first group session (Cronbach’s α = .91 and .94, respectively) and at 2 months were

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tested as confounds. Four-month ratings of confidence in recommending the therapy and attribution of improvement to the treatment were analyzed as feasibility outcomes.

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Treatments

All participants attended a weekly 2-hour group therapy session for 16 weeks and paid for

each session on a sliding scale of $0-65. The group was open and ongoing, and participants could join at weeks 1, 2, and 9 of the curriculum (see Table 1). All participants had access to 16 sessions of group therapy and met individually with their group therapist once for a 30-min private orientation session in which a crisis plan was established. Outside of this session,


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participants did not have any contact with an individual therapist. Participants who missed 4 consecutive weeks were considered treatment dropouts but could still participate in assessments. If they declined assessment participation, they were considered study withdrawals (and were

therapist) and a coleader (an untrained bachelor’s-level assistant).

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marked as “lost to follow up” in Figure 1). Each group had a leader (a trained master’s-level

DBT-ST. DBT-ST was designed to retain the essence of standard DBT, adopting the

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same philosophical base, treatment strategies, and treatment targets. The DBT-ST therapist

focused on teaching participants DBT skills and utilized modeling, step-by-step instructions,

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structured behavioral rehearsal exercises, feedback, and homework assignments for this purpose. DBT-ST included two modifications to standard DBT that the treatment developer approved. First, the protocol was shortened from 24 weeks to 16 (Table 1) to correspond in length with other evidence-based treatments for this population (e.g., Dimidjian et al., 2006). To

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this end, skills from the interpersonal effectiveness module were taught together with distress tolerance in a shorter amount of time then recommended by the original manual (Linehan, 1993b). This decision was based on evidence that interpersonal skills may not be needed to

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reduce emotion dysregulation (Gratz et al., 2006). Second, because of financial constraints, the group coleader was not a trained DBT therapist.

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Each session started with a mindfulness practice and review of homework (~40 min) and

ended with skills instruction and homework assignment (~75 min). Sessions 1 and 9 included longer instruction segment (~110 min). Participants tracked their use of skills each day with written diary cards, which were reviewed weekly. (Diary card data are not included in analyses.) ASG. ASG was designed to control for common factors based on principles of clientcentered supportive therapy. ASG therapists aimed to foster a sense of belongingness, maintain


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unconditional positive regard, and provide empathy, psychoeducation, and a treatment structure. Teaching DBT skills and using cognitive-behavioral strategies in ASG were prohibited. Each session started with a review of participants’ experiences over the last week (~30

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min) and a support-building activity (~30 min) and ended with an open group discussion about topics participants chose each week (~50 min). The most commonly discussed topics were anger, anxiety, communication, coping, goals, sleep, stress, and depression. For homework, participants

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were asked to think about issues discussed and to track daily social support on diary cards.

Therapists and supervision. DBT groups were led by the first author, a master’s-level

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clinician who had participated in several DBT trainings (including a weeklong intensive training) and had 3 years of experience providing DBT under the supervision of the treatment developer. An expert DBT supervisor watched sessions and provided supervision weekly. In accordance with the DBT model, the therapist and coleaders also attended weekly DBT team meetings.

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Two clinicians who held Master of Social Work (MSW) degrees and who had 3 years of experience conducting group psychotherapy led the ASG groups. Before the study started, both therapists studied the ASG manual and were trained in the study protocols by an expert

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community clinician who had prior experience conducting and supervising ASG groups. ASG therapists also received training in suicide assessment and management from the first author.

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ASG therapists and coleaders received weekly supervision from the community expert. Adherence. An independent coder trained to reliability with the clinic gold standard in

the DBT Global Rating Scale (Linehan & Korslund, 2009) rated 10% of DBT group sessions for adherence. Because no adherence scale for supportive therapy could be found, we developed a coding system (available upon request) to assess adherence to ASG. A coder naïve to DBT was trained in the ASG adherence scale and rated 20% of the ASG sessions. We decided to code


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more sessions for ASG adherence because the measure used had not been validated. Ancillary treatment changes. Participants were classified as compliant or noncompliant with the ancillary treatment protocol at each assessment period. Participants were deemed

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noncompliant if they reported (a) adding, dropping, or changing the dosage of a psychotropic medication or (b) seeing a psychotherapist outside the study. Participants were allowed to continue regardless of their compliance. Noncompliance was tested as confound.

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Statistical Analysis

Longitudinal outcomes. HLM (Bryk & Raudenbush, 1992) was used to assess

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differences between conditions over time. Appropriate covariance structures were analytically determined (Verbeke, 1997), and the analyses included a restricted estimated maximum likelihood model to account for missing data (Schafer & Graham, 2002). Assuming that the main effects were different during the active phase of treatment versus the follow-up phase of the

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study, we separated the time variable into two legs. The first leg (time1) was coded as continuous throughout treatment and constant at follow-up, whereas the second leg (time2) was coded as constant throughout treatment and continuous at follow-up. Time1 and time2 were both used as

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fixed effects and together yielded two time-by-condition interactions (one for treatment and one for follow-up). Each analysis included four a priori contrasts—two for each study phase—to

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assess the significance of each condition slope. Effect sizes were computed using Feingold (2009)’s formula and interpreted using Cohen (1988)’s specifications. Confounds. To assess whether another variable could better explain treatment effects, we

tested confounds as covariates. Each analysis added to the model described above the potential confound and two time-by-confound interactions (one for time1 and one for time2) as fixed effects. If the covariate main effect was significant, it was kept in the outcome’s HLM model as


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a moderator; if it was not significant, it was removed. We tested six confounds: (a) use of psychotropic medication, (b) receipt of ancillary psychotherapy, (c) illegal drug use (each yes/no), (d) treatment credibility, (e) expectancy of improvement, and (f) age. In addition, we

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assessed whether ancillary treatment changes (i.e., changing medication dose, starting/stopping a medication, participating in ancillary psychotherapy) explained treatment effects by conducting independent analyses on only participants who complied with the study requirement to maintain

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ancillary treatments unchanged.

Clinically significant change. Following Jacobson and Truax’s (1991) method, we used

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change scores, instrument reliability, and clinical and nonclinical distributions to classify each participant as deteriorated/unchanged, improved, or recovered.

Mediation. We tested mediation hypotheses using Krull and MacKinnon’s (2001) statistical procedures and the specifications described by Kramer, Wilson, Fairburn, and Agras

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(2002). Tofighi and MacKinnon’s (2011) distribution-of-the-product method was employed to compute the mediation effect (α path*β path) and a confidence interval (CI) that determines its significance. Mediation equations used a single-level HLM model in which the overall condition

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effect throughout the study was the independent variable. We computed the percentage of the

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total effect explained by the mediator to better understand these results. Results

Sample Characteristics and Baseline Differences Participants were primarily single, heterosexual, Caucasian women who met criteria for

multiple Axis I disorders (Mdiagnoses = 2.68, SD = 1.21 in DBT-ST; Mdiagnoses = 2.59, SD = 1.44 in ASG). Current GAD, MDD, and dysthymia were the most frequent diagnoses. Randomization successfully matched participants on gender, psychotropic medication use, and primary diagnosis.


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No significant demographic differences emerged (Table 2). At pretreatment, 18 participants (40.9% in each condition) reported taking a mean of 1.39 (SD = 0.61) medications for anxiety, depression, or mood (Supplementary Table S1). Participants joined their assigned therapy groups

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on average 13.66 days after pretreatment (SD = 12.72, and no difference arose between conditions, t(42) = -0.18, p = .86.

The average adherence score for a random sample of 6 out of 64 DBT-ST sessions was 4.0 (SD =

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0.18), indicating that the treatment was adherent to the DBT model. In addition, only 1 out of 9 randomly selected ASG sessions (43 total) was nonadherent.

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Preliminary Analyses

A preliminary examination of outcomes showed that, for the entire ITT sample, depression severity moderately correlated with skills use (r = -.32, p < .05) and anxiety severity (r = .31, p < .05) at pretreatment. We found no other significant correlations between outcomes

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(ps > .05). HLM main effects, slope estimates, and standard errors for ITT and completer analyses are included in Table 3. (Supplementary Figure 1 shows raw score averages for the ITT sample.) Confound analyses showed that use of psychotropic medications significantly predicted

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changes in emotion dysregulation on the DERS (F(1, 152.91) = 5.87, p < .05); therefore, this confound was included as a covariate in DERS analyses. No other confound was significant

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(Supplementary Table S2).

For clinical significance analyses, we computed cutoffs based on Jacobson and Truax’s

(1991) specifications using DERS data from nonclinical (Fox et al., 2007; Harrison et al., 2009) and clinical (Whiteside et al., 2007; Salters-Pedneault et al., 2006; Fox et al., 2007; Harrison et al., 2009) samples and PHQ-9 and OASIS data from nonclinical (Kroenke et al., 2001), depressed (McMillan et al., 2010), and anxious (Norman et al., 2011) samples. For reliable


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change indices (RCIs), we used the test-retest reliabilities reported in the original validation studies for all measures except the DERS, for which we computed reliability using data from 30

See Figure 2 for results. Changes in Emotion Dysregulation as a Function of Skills Use

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participants who completed the measure both on the phone and at pretreatment (r = .47, p < .01).

ITT analyses revealed that during treatment all participants reported significantly less

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emotion dysregulation over time, but those in DBT-ST improved significantly more and faster (d = 1.86). We found no significant difference in slopes for participants who were versus were not

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taking psychotropic medications; therefore, we present slope results per condition combining participants regardless of medication use (Table 3). At follow up a significant time by condition interaction favored ASG. Although neither the DBT-ST nor the ASG slope was significant, participants in DBT-ST trended toward losing some of their gains, while participants in ASG

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trended toward continuing to improve. Completer analyses (n = 24) yielded similar findings, except only ASG participants taking medication significantly improved in emotion regulation during treatment: slope estimate = -6.56, SE = 4.49, t(75.53) = -1.46, p = .15;

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slope estimate = -10.57, SE = 4.87, t(78.11) = -2.17, p = .03. Clinical significance analyses (Figure 2) showed a significant difference in recovery from emotion dysregulation

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favoring DBT-ST at each time point (U2 months = 135.00, U4 months = 99.50, Ufollow-up = 117.00, respectively, ps < .05).

Longitudinal ITT analyses using the DBT-WCCL indicated that during treatment only

DBT-ST participants significantly increased their skills use over time (d = 1.02). During followup, participants did not change significantly, suggesting that DBT-ST participants maintained their gains. By the end of treatment, the skills use reported by ITT participants increased by


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16.00% in DBT-ST and 3.48% in ASG. Completer analyses showed similar results, although the interaction effect during treatment was only a trend (Table 3). A significant difference in classification (ps .05). Changes in Psychopathology

Depression severity. Thirty-six participants who were clinically depressed at

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pretreatment based on a score above the clinical cutoff (9) on the PHQ-9 were analyzed for differential changes over time in depression severity. During treatment, ITT participants in both

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conditions improved significantly and similarly (d = 0.73). During follow-up, no main effect of time was present, but a trend for a significant interaction favored ASG. After treatment, DBT-ST participants slightly worsened, reporting a significant increase in depression severity from end of treatment to follow-up, while ASG participants did not report a significant change. Even with losses in depression gains, DBT-ST ITT participants significantly improved during the study in their depression severity. The effect size for changes from pre- to post-treatment was 2.34 in


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DBT and 1.32 in ASG; from pretreatment to follow-up it was 1.59 in DBT and 1.47 in ASG. Completer analyses indicated that only DBT-ST led to significant improvements in depression severity during treatment, although the time-by-condition interaction was not significant. At

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follow-up no significant changes for treatment completers were present, suggesting DBT-ST completers maintained their gains (Table 3). Clinical significance analyses revealed no

significant difference in classification between conditions (Figure 2). Use of skills mediated the

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relationship between condition and change in depression severity (Table 4).

Anxiety severity. Thirty-five participants who were clinically anxious at pretreatment

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based on a score above the clinical cutoff (7) on the OASIS were analyzed for differential changes in anxiety severity. During treatment, all ITT participants significantly improved in their anxiety severity, but DBT-ST participants improved significantly faster (d = 1.37). Follow-up ITT analyses showed no significant effect of time but revealed a significant interaction favoring

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ASG. DBT-ST participants lost some of their gains from the end of treatment to follow-up. Even with the loss in some gains, DBT- ST participants significantly improved in their anxiety severity over all time points. The effect size for changes from pre- to post-treatment was 1.34 in

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DBT-ST and 0.67 in ASG; from pretreatment to follow-up it was 1.98 in DBT-ST and 1.08 in ASG. Completer analyses revealed similar results, with the interaction effect’s approaching

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(although not reaching) significance during treatment (Table 3). Clinical significance analyses revealed no significant difference in classification between conditions for anxiety (Figure 2). The overall main effect of condition was not significant for anxiety severity; therefore, following Kramer et al. (2002)’s guidelines, we added the interaction between skills use and condition to the mediation model and found significant condition and interaction effects, F(1, 147.65) = 5.03, F(1, 153.39) = 4.43, respectively, ps < .05. Thus, skills use mediated anxiety severity


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differentially by condition. Feasibility of Treatment and Research Protocol More participants dropped treatment in ASG (n = 13) than DBT-ST (n = 7), a

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nonsignificant difference, χ2 = 3.3, p = .07. Clients attended on average two thirds of the sessions in DBT-ST (M = 10.27, SD = 4.72) and half in ASG (M = 7.73, SD = 5.21; U = 177.50, p = .13). At the end of treatment, participants in DBT-ST attributed significantly greater improvement in

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depression and/or anxiety (M = 53.33%, SD = 21.14) to their treatment than participants in ASG (M = 26.88%, SD = 25.81), t(32) = 3.28, p < .01. In addition, DBT-ST participants reported

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significantly higher confidence in recommending their therapy to a friend (M = 6.58, SD = 2.35) than participants in ASG (M = 4.06, SD = 2.86), t(32) = 2.82, p < .01. During treatment and follow-up, 13 clients (5 in DBT-ST, 8 in ASG) changed their medication, and 12 clients (7 in DBT-ST, 5 in ASG) participated in ancillary psychotherapy. In

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total, 20 clients (9 in DBT-ST, 11 in ASG) did not comply with the research requirement of not engaging in ancillary psychotherapy or making changes to psychotropic medication regimens throughout the study. Of these, 6 in DBT-ST and 5 in ASG were treatment completers. We

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conducted independent HLM analyses including only compliant ITT participants (13 in DBT-ST and 11 in ASG) and found similar results with two exceptions: (a) compliant ASG participants

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did not improve significantly over time in their reported difficulties with emotion regulation, depression severity, or anxiety severity (ps > .05) and (b) no significant interaction effect at follow-up for emotion dysregulation emerged (Supplementary Table S3). Discussion

The present study is a preliminary examination of DBT skills training (DBT-ST) as a stand-alone treatment for emotion dysregulation in a transdiagnostic sample. Compared with a


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supportive therapy control condition (ASG), DBT-ST was superior in improving emotion dysregulation, increasing skills use, and reducing anxiety in adults who met criteria for depressive and/or anxiety disorders. Although DBT-ST was comparable to ASG in reducing

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depression severity, recovery from depression was twice as high in DBT-ST (71.4%) as in ASG (31.3%) based on clinical significance analyses. Differential improvements between conditions were not better explained by use of psychotropic medication or illicit drugs, participation in

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ancillary psychotherapy, expectancies of improvement, treatment credibility, or age. Moreover, use of DBT skills mediated differential changes between conditions in emotion dysregulation

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and psychopathology. Participants also found the intervention acceptable, although dropout from treatment was high (32% in DBT-ST, 59% in ASG) and 45% of participants did not comply with the research protocol to keep ancillary treatments constant. Although neither noncompliance nor dropout impacted our results, the feasibility of DBT-ST as a standalone treatment needs further

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investigation. Taken together, these findings suggest that (a) DBT-ST may be a promising transdiagnostic intervention that contains an active mechanism of change for reducing emotion dysregulation, (b) targeting emotion dysregulation transdiagnostically has a positive effect on

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psychopathology, and (c) future studies should more thoroughly examine and improve the feasibility of DBT-ST as a standalone intervention.

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As hypothesized for our primary aim, DBT-ST participants showed a faster reduction in

difficulties with emotion regulation than those in ASG, although both treatments were efficacious. DBT-ST was more successful than ASG in increasing access to regulation strategies and goal-directed behavior during emotional events, outcomes that directly map onto the emotion regulation and distress tolerance skills modules taught in DBT. The lack of a significant finding for differential changes in emotional awareness, clarity, or acceptance suggests that


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additional emphasis on mindfulness and psychoeducation about emotions may be needed to extend treatment effects. Nevertheless, DBT-ST helped three times more participants (57.9%) than ASG score in a nonclinical range on emotion dysregulation by the end of treatment. Only

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DBT-ST participants reported using significantly more skills over time in treatment and

maintained their gains at follow-up. By the end of the study, 47.6% of DBT-ST participants reliably improved their skills use—only 5.6% of ASG participants did the same. In addition to

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supporting the internal validity of our study, this finding highlights that direct teaching and

practice of skills is more effective than general discussion and support at increasing skills use.

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Furthermore, in the present study, skills use explained 62% of the variance in mediating the differential improvement in emotion dysregulation between conditions, confirming our second hypothesis and suggesting that increased skills use may in turn reduce emotion dysregulation. For our second primary aim, we explored the effects of targeting emotion dysregulation

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on the severity of psychopathology and found promising results. The DBT-ST pre-post effect sizes for improvements in anxiety and depression severity are comparable to those reported in trials for depression (d = 1.34-2.92; Dimidjian et al., 2006; Westbrook & Kirk, 2005) and various

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anxiety disorders (d = 0.92-2.06; McEvoy & Nathan, 2007; Norton & Price, 2007; Stewart & Chambless, 2009). Teaching skills had a greater effect than offering supportive therapy in

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reducing anxiety severity but had a comparable effect in reducing depression severity. These findings suggest that not directly addressing a primary disorder but targeting a transdiagnostic problem does not negatively impact psychopathology and may lead to significant improvements. In addition, skills use may be a mechanism of change for depression and anxiety severity. Future studies should more thoroughly investigate these hypotheses. An unexpected finding was that at follow-up DBT-ST participants lost some of their


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improvement in emotion dysregulation, anxiety, and depression. By contrast, ASG participants continued to improve. We hypothesize that the motivational support received during the DBT-ST treatment may explain this finding. In DBT-ST (unlike in ASG), participants were strongly

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encouraged to use skillful behavior through homework assignments, discussion, rewards for homework completion, and punishment (doing behavioral analyses) for homework

noncompliance. In addition, use of specific skills was shaped and optimized via weekly feedback.

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Therefore, participants in DBT-ST may have been motivated to use skills more effectively during treatment and hence to experience more relief from psychopathology and emotion

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dysregulation. Once treatment ended, participants may have reduced their efforts (given that the motivational component was no longer available) and as a result may have experienced some loss of gains. Future studies should test this hypothesis and provide solutions to improve generalizability. Nevertheless, it is important to highlight that participants did not lose all their

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gains at follow-up. Over the course of the entire study DBT-ST participants improved significantly on all outcomes.

Our supplementary aim was to assess the feasibility of offering a group treatment to a

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transdiagnostic sample with high emotion dysregulation. We assessed feasibility by exploring treatment retention rates, compliance with the research protocol, and satisfaction with the

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treatment. We considered our sample difficult to treat in light of evidence suggesting that difficulties with emotion regulation are connected with less willingness to engage in mental health treatment (e.g., Ciarrochi & Deane, 2001; Vogel, Wade, & Hackler, 2008). In DBT-ST, 14% of participants dropped out because they wanted individual therapy, 9% lost interest, and 9% could no longer attend group because of scheduling issues. The treatment retention rate in DBT-ST (68%) is lower than the retention rates of other treatments for depression (e.g., 77%;


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Kwan, Dimidjian, & Rizvi, 2010; Harley et al., 2008) or anxiety (e.g., 73%; van Ingen, Freiheit, & Vye, 2009), but consistent with those of other treatments for transdiagnostic or difficult-totreat samples, including a BPD group (66%; Soler et al., 2009); oppositional defiant sample

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(60%; Nelson-Gray et al., 2006); domestic violence group (67%; Iverson et al., 2009); and group of anxious and depressed participants (59%; McEvoy et al., 2007). Therefore, skills-only

interventions for clients who are difficult to treat or transdiagnostic may have higher dropout

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rates than group therapies designed for specific diagnoses. Although this finding suggests that DBT-ST is as feasible for a transdiagnostic sample as it is for other difficult-to-treat samples, it

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also highlights the need to reduce dropout from DBT-ST. Retention may be improved by (a) allowing adjunctive individual therapy, (b) offering more groups to accommodate clients’ schedules, or (c) permitting a flexible number of group sessions to allow for faster/slower improvement.

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Regarding compliance, 32% of all participants obtained additional psychotherapy. The majority were noncompliant by either not ending previous psychotherapy relationships until after baseline or by seeking additional treatment during the follow-up period of the study. Analyses

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using only compliant participants indicated that noncompliance with the protocol did not affect our findings. Nevertheless, the rate of noncompliance is concerning for the feasibility of the

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intervention as a stand-alone treatment. Future research may improve compliance by allowing more time for previous therapy to end before baseline or by providing more group sessions for participants who still need psychotherapy after 16 weeks. Our results suggest that participants found DBT-ST acceptable. DBT-ST participants

attributed their improvement in depression and/or anxiety to the treatment and reported above average confidence in recommending the treatment to a friend. Although the feasibility of DBT-


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ST needs further evaluation, our treatment dropout, compliance, and satisfaction findings suggest that DBT-ST has promise as a stand-alone, transdiagnostic treatment for emotion dysregulation. Our findings also have important implications for assessment. Assessment burden is a

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well-known problem for clients and clinicians in “real-world” mental health settings. The

structured interviews used in efficacy trials are rarely utilized in clinical practice (Garland, Kruse, & Aarons, 2003). In the present study, we conducted structured interviews to establish the

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diagnostic profile for participants who scored over 96 on the DERS and participated in an inperson screening assessment. Out of 90 participants, only one did not meet criteria for a current

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DSM-IV disorder on the SCID-I (but did meet criteria for MDD in partial remission). The DERS took 7 minutes to complete, did not require reliability training, and yielded a group of participants who responded to treatment. Thus, using the DERS with a cutoff of 97 identifies a clinical sample for which an intervention with preliminary support exists.

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It is important to highlight that our main goal was to assess DBT-ST as a treatment for transdiagnostic emotion dysregulation in a clinical sample and not to develop a new treatment for anxiety or depression. Therefore, our study does not answer the important question of whether

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DBT-ST would improve upon already existing evidence-based treatments for these disorders or whether existing treatments for anxiety and depression sufficiently change emotion dysregulation.

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Future studies should address such questions. The present study has several limitations. First, therapist characteristics may have

affected treatment effectiveness because different therapists conducted the different interventions (Wampold & Serlin, 2000). Second, we had insufficient power to detect differences in several analyses (e.g., depression, completer analyses). Third, the mediation analyses were underpowered and were not designed to account for the mediator-outcome temporal relationship


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(e.g., MacKinnon, Fairchild, & Fritz, 2007). Fourth, high dropout in ASG (59%) and low session completion in both DBT-ST and ASG occurred. Fifth, although both conditions contained equal numbers of participants with primary depressive disorders, ASG contained significantly more

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dysthymic participants than DBT-ST.

In summary, DBT-ST is a promising treatment for transdiagnostic emotion dysregulation, with a potentially active ingredient (skills use) and a positive effect on psychopathology;

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and protocol compliance and to maintain durable gains.

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nevertheless, DBT-ST can benefit from further assessment and development to enhance retention


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Taylor, S. F. & Liberzon, I. (2007). Neural correlates of emotion regulation in psychopathology. Trends in Cognitive Sciences, 11, 413-418.

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negative affect? Eating Behaviors, 8(2), 162-169. doi:10.1016/j.eatbeh.2006.04.001

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Table 1. DBT-ST Curriculum and Targeted Components of the Emotion Dysregulation Model

5 6 7

One Mindful, Effective

All components

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4

Emotion Regulationb

3

Describe, Participate, Nonjudgmental,

Understand, identify, label emotions

Processing emotions

Check the Facts

Interpretations in emotional situations

Opposite Action

Managing expression/action changes

Problem Solving

Managing situations that cue emotions

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2

Wise Mind, Observe

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1

Target problems witha

Selected skills

Mindfulnessb

Week

Accumulate Positives & Build Mastery

Managing vulnerability to emotions

9

Mindfulness review

10

TIP body chemistry, extreme emotions

Managing biological/experiential changes

Distract, Self Soothe, Improve Moment

Controlling attention

14 15 16


Willingness, Half Smile,

Managing biological/experiential changes,

Mindfulness of Thoughts

interpretations in emotional situations

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13

All components

Radical Acceptance, Turning the Mind

DEAR MAN GIVE FAST


Interpersonal Validation


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12

Interpersonal Effectivenessb

11

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Cope Ahead & PLEASE

Distress Toleranceb

8

Behavioral principles in relationships


Note. Weeks in which participants could join the group are in boldface.aSee Neacsiu, Bohus, an Linehan (2013) for a full description of the treatment model of emotion dysregulation. bIndicates the DBT skills training module in the original skills manual (Linehan, 1993b).

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Table 2. Participant Demographic and Clinical Characteristics by Condition (n = 22 in each condition)

32.27 (10.50) 38.82 (13.55) t(42) = 1.79 .08 Depressive disorder 68.2%

63.6%

40.9%

Dysthymic disorder

4.5%

45.5%

NOS

4.5%

0.0%

1.00 Anxiety disorder

90.9%

86.4%

1.00

Panic disorder

9.1%

18.2%

χ²(1) = 0.30 .30

Agoraphobia

4.5%

9.1%

U = 221.00 .55

Generalized anxiety

77.3%

54.5%

Social phobia

36.4%

36.4%

Specific phobia

13.6%

22.7%

Obsessive-compulsive 18.2%

4.5%

Posttraumatic stress

13.6%

4.5%

NOS

4.5%

13.6%

13.6%

0.00%

90.9%

Hispanic ethnicity

4.5%

9.1%

FE

LGBTQ

18.2%

13.6%

FE

Single/divorcedc

81.8%

61.2%

Lifetime diagnoses Depressive disorder

95.5%

Anxiety disorder

72.7%

SUD

40.9%

1.00

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2.41 (1.30)

U = 199.00 .30

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2.00 (1.20)

81.8%

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No. BPD symptomsa

72.7%

pa

59.1%

FE

63.6%

Test

Major depression

95.4%

≥ College graduate

ASG

68.2% χ²(1) = 0.00 1.00

χ²(1) = 0.10 .75

Education

DBT-ST 68.2%

Racial Background Caucasian

pa Current Disorders

Test

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Femaleb

ASG

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Age (years)a

DBT-ST

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Demographics

FE

.35

72.7%

χ²(1) = 0.00 1.00

59.1%

χ²(1) = 0.23 .23 SUD

FE

1.00

FE

.23

Note. LGBTQ = Lesbian, Gay, Transgender, Questioning Sexuality; NOS = not otherwise specified; SUD = substance use disorder; FE = Fisher’s Exact test. aM (SD) reported. Analyses compared condition by (1) bmales vs. females; (2) cmarried vs. not married.

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Table 3. HLM Slope Estimates and Fixed Effects for the Intent to Treat and the Completer Samples Intent-to-treat Sample (n = 44) Effect

df

F

p

Time

1, 124.91

64.49

***

DBT-ST slope

Completer Sample (n = 24) ASG slope

df

F

p

1, 70.18

30.21

***

DBT-ST slope

ASG slope

1, 123.22

10.42

**

Time

1, 143.03

0.15

.70

FU

4.28 (3.54) Interaction

1, 143.18

4.15

*

Time

1, 115.04

16.18

*** 0.23 (0.05)***

Interaction

1, 115.04

5.87

*

Time

1, 138.63

1.79

.18

FU

-0.12 (0.07) Interaction

1, 138.63

0.75

.39

Time

1, 95.89

45.25

***

TX

-3.99 (0.73)*** 1, 95.89

1.57

.21

Time

1, 93.45

2.02

.16

FU

3.18 (1.40)*

Interaction

1, 93.45

3.29

.07

Time

1, 92.41

39.29

***

TX OASISc,d

F

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PHQ-9b

Interaction

-2.96 (0.43)***

Interaction

1, 92.41

7.83

**

Time

1, 89.16

0.91

.34

2.04 (.82)*

U

Interaction

1, 89.16

5.08

*

-5.62 (3.73)

0.06 (0.05)

1, 69.99

30.21

*

1, 81.73

0.53

.47

1, 82.67

6.05

*

1, 67.52

6.85

*

1, 67.52

2.92

.09

1, 82.78

0.18

.67

1, 82.78

2.23

.14

1, 53.00

10.79

**

1, 53.00

2.58

.11

1, 53.00

0.36

.55

1, 53.00

1.37

.25

1, 63.95

8.96

**

1, 63.95

2.73

.10

1, 65.71

0.02

.89

1, 65.71

5.49

*

-0.03 (0.08)

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DBT-WCCLa

TX

EP

DERS

Interaction

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-19.44 (2.4)*** -8.33 (2.48)**

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TX

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Phase

-2.74 (0.69)***

-0.39 (1.38)

-19.99 (3.14)*** -8.28 (4.08)*

6.44 (4.60)

-10.3 (5.97)

1.63 (0.46)***

0.34 (0.60)

-0.58 (0.67)

1.05 (0.87)

-3.54 (0.88)***

-1.21 (1.15)

2.46 (1.68)

-0.79 (2.20)

-0.44 (0.12)***

-0.13 (0.15)

0.37 (0.19)

-0.33 (0.23)

-1.13 (0.49)*

-0.82 (0.98)

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Note. Completer analyses include transformations using aexponential/csquare root functions. TX = Treatment phase of the study; FU = Follow Up phase of the study. Only participants who scored over the bPHQ-9/dOASIS cutoff at pretreatment were included: b36/19 for the ITT/completer

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PHQ-9 analyses and d20/35 for the OASIS analyses. * p 77 o o o o o o o o

Phone screen (n = 406)

Enrollment In-person screen (n = 92)

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• 58 were not interested • 32 eligible declined further screening

Excluded (n = 44) • 2 did not consent to screening assessment • 4 had bipolar disorder • 28 had BPD • 1 did not have any mood/anxiety disorder • 9 were eligible but declined participation

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Referred elsewhere (n = 314) • 224 were ineligible

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Randomized (n = 48)

Allocation

DBT-ST (n = 24) Received intervention (ITT n = 22) Dropped before group start (n = 2)

• •

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• •

ASG (n = 24) Received intervention (ITT n = 22) Dropped before group start (n = 2)

2 month

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Lost to follow-up (n = 0) Discontinued intervention (n = 2) • 2 wanted a different treatment

Lost to follow-up (n = 0) Discontinued intervention (n = 5) • 2 had scheduling issues • 2 lost interest • 1 wanted a different treatment

Lost to follow-up (n = 2) Discontinued intervention (n = 11) • 8 wanted a different treatment • 2 had scheduling issues • 1 lost interest

4 month Lost to follow-up (n = 1) Discontinued intervention (n = 2) • 2 wanted a different treatment

2 month follow-up

Lost to follow-up (n = 0)

Figure 1. Participant flowchart. DBT-ST = Dialectical Behavior Therapy Skills Training; ASG = Activities Support Group; All participants included in analyses; Lost to follow up = participants who dropped out of the study completely; participants who discontinued the intervention but did not drop out of the study continued with assessments; DERS = Difficulties in Emotion Regulation Scale; BSL = Borderline Symptoms List

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Figure 2. Includes only participants who were depressed based on a aPHQ-9 cutoff (n = 36) or a bOASIS cutoff (n = 35).

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Highlights

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Use of skills explained the differences between conditions on all outcomes. DBT skills training was acceptable, although feasibility needs further testing.

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We piloted a group treatment for transdiagnostic emotion dysregulation. We conducted a randomized controlled trial using a support group as control. DBT skills training was successful in reducing difficulties in emotion regulation.

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• • • • •

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Supplementary Table S1. Frequency of Medication Use Reported at Pretreatment. Condition Generic name

1

Citalopram

SSRI

Duloxetine

SNRI

Lamotrigine

Anticonvulsant

Mirtazapine

Tetracyclic antidepressant

1

Paroxetine

SSRI

1

Sertraline

SSRI

Venlafaxine

SNRI

Lamotrigine

Anticonvulsant

1

Quetiapine

Atypical antipsychotic

1

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Atypical antidepressant

2

3

1

2

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1 1

Atypical antipsychotic

Alprazolam

Benzodiazepine

Bupropion

Atypical antidepressant

1

Buspirone

Azapirone

1

1

Clonazepam

Benzodiazepine

1

1

Escitalopram

SSRI

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Risperidone

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Mood

Anxiety

ASG

Bupropion

Depression

stabilization

DBT-ST

Classification

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Prescribed for

1 2

Note. SSRI = selective serotonin reuptake inhibitor; SNRI = serotoninnorepinephrine reuptake inhibitor

1

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Supplementary Table S2. Significance of HLM Fixed Effects of Potential Confounds

ancillary therapy

(1, 152.61)

WCCL

1.52

DERS

(1, 152.91) 5.87

PHQ-9a

OASISb

.22

(df) F

0.16

*

0.01

.69

0.58

.91

0.94

0.0001 (1, 103.37)

.38

0.66

.45

0.001

.33

0.38

p

0.53

0.13

.97

.54

1.72

.47

.72

2.81

0.0003

.20

1.75

.10

0.18

(df) F

p

0.01

.92

(1, 147.15) .99

0.37

.54

(1, 96.17) .19

(1, 44.49) .93

Age

(1, 69.00)

(1, 50.52)

Note. Includes only participants who scored above aPHQ-9 cutoff or bOASIS cutoff at baseline. *p < .05

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p

(1, 45.17)

(1, 50.75) 0.01

(df) F

(1, 48.74)

(1, 59.94)

(1, 114.81)

.42

(df) F

(1, 57.92)

(1, 118.80) .99

improvement

(1, 57.43)

(1, 143.69)

(1, 119.65) .34

p

(1, 140.08)

(1, 135.72)

(1, 116.21) 0.76

p

(1, 129.81)

(1, 119.90) 0.94

(df) F

credibility

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DBT-

p

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(df) F

Illicit drug use

Expectancy of

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medication use

Treatment

SC

Receipt of

EP

Outcome

Psychotropic

0.79

.38

(1, 62.78) .68

0.73

.40

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Supplementary Table S3. HLM Slope Estimates and Fixed Effects for Participants Who Did Not Modify Their Ancillary Treatments

TX DBT-WCCL

FU

PHQ-9a

TX

FU

Time

1, 68.19

38.82

***

Interaction

1, 68.59

15.49

***

Time

1, 67.89

0.01

.83

Interaction

1, 67.94

2.16

.15

Time

1, 64.18

7.31

**

Interaction

1, 64.18

6.36

*

Time

1, 66.46

0.93

.34

Interaction

1, 66.46

0.48

.49

Time

1, 47.43

19.97

***

Interaction

1, 47.43

2.70

.11

Time Interaction

0.67

.42

1, 44.93

4.71

*

1, 56.08

19.62

***

Interaction

1, 56.08

5.20

*

Time

1, 55.87

0.40

.53

1, 55.87

4.31

*

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FU

Time

1, 44.93

EP

OASISb,c

TX

Interaction

DBT-ST slope

ASG slope

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p

-23.97 (2.74)***

-5.01 (3.28)

5.85 (4.36)

-6.35 (5.45)

SC

DERS

FU

F

0.25 (0.06)***

0.01 (0.07)

-0.13 (0.10)

-0.02 (0.12)

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TX

df

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Phase Effect

-4.12 (0.94)***

-1.91 (0.96)

3.98 (1.79)*

-1.80 (1.97)

-0.64 (0.12)***

-0.20 (0.15)

0.43 (.19)*

-0.23 (0.25)

Note. TX = treatment; FU = follow-up. Interactions are time × condition. Participants included in analyses only if they scored above the aPHQ-9 clinical cutoff or bOASIS cutoff at baseline. c

OASIS score transformed using the square root transformation for normality. *p < .05; **p
.05.

Pilot randomized controlled trial of dialectical behavior therapy group skills training for ADHD among college students.

Dialectical behavior therapy skills use and emotion dysregulation in personality disorders and psychopathy: a community self-report study.

Emotion Regulation in Schema Therapy and Dialectical Behavior Therapy.

Acceptance-based Behavior Therapy for Depression With Psychosis: Results From a Pilot Feasibility Randomized Controlled Trial.

Emotion acceptance behavior therapy for anorexia nervosa: a pilot study.

Assertive Anger Mediates Effects of Dialectical Behaviour-informed Skills Training for Borderline Personality Disorder: A Randomized Controlled Trial.

Interview skills for adults with autism spectrum disorder: a pilot randomized controlled trial.

Problem-solving skills training for parents of children with chronic pain: a pilot randomized controlled trial.

Adapting dialectical behavior therapy for outpatient adult anorexia nervosa--a pilot study.

A randomized waitlist-controlled pilot trial of voice over Internet protocol-delivered behavior therapy for youth with chronic tic disorders.

A pilot study of maudsley family therapy with group dialectical behavior therapy skills training in an intensive outpatient program for adolescent eating disorders.

A pilot randomized controlled trial of deprescribing.

Comparative efficacy of behavior therapy, cognitive therapy, and cognitive behavior therapy for chronic insomnia: a randomized controlled trial.

Integrating Family-Based Treatment and Dialectical Behavior Therapy for Adolescent Bulimia Nervosa: Preliminary Outcomes of an Open Pilot Trial.

Relating therapy for voices (the R2V study): study protocol for a pilot randomized controlled trial.

Investigating bang for your training buck: a randomized controlled trial comparing three methods of training clinicians in two core strategies of dialectical behavior therapy.

Efficacy and cost-effectiveness of an experimental short-term inpatient Dialectical Behavior Therapy (DBT) program: study protocol for a randomized controlled trial.

Aerobic exercise for Alzheimer's disease: A randomized controlled pilot trial.

Vilazodone for cannabis dependence: A randomized, controlled pilot trial.

Combining emotion regulation and mindfulness skills for preventing depression relapse: a randomized-controlled study.

A Computerized Cognitive behavioral therapy Randomized, Controlled, pilot trial for insomnia in Parkinson Disease (ACCORD-PD).

Randomized, controlled pilot trial of a smartphone app for smoking cessation using acceptance and commitment therapy.

A Pilot Randomized Controlled Trial of Cognitive-Behavioral Therapy for Adolescents With Body Dysmorphic Disorder.

Online CBT life skills programme for low mood and anxiety: study protocol for a pilot randomized controlled trial.