مهارت رفتار درمانی دیالکتیکی برای اختلال در نظم احساسات فراتشخیصی: پایلوت کارآزمایی تصادفی کنترل شده

Difficulties with emotions are common across mood and anxiety disorders. Dialectical behavior therapy skills training (DBT-ST) reduces emotion dysregulation in 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. 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). Participants completed measures of emotion dysregulation, DBT skills use, and psychopathology every 2 months through 2 months posttreatment. 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 = 1.37) but not depression (d = 0.73). Skills use mediated these differential changes. Participants found DBT-ST acceptable. Thirty-two percent of DBT-ST and 59% of ASG participants dropped treatment. Fifty-nine percent of DBT-ST and 50% of ASG participants complied with the research protocol of avoiding ancillary psychotherapy and/or medication changes. In summary, DBT-ST is a promising treatment for emotion dysregulation for depressed and anxious transdiagnostic adults, although more assessment of feasibility is needed.

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Sample characteristics and baseline differences ITT 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. 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, on average, 13.66 days after pretreatment (SD = 12.72), and no significant difference arose between conditions, t(42) = −0.18, p = .86. Table 2. Participant demographic and clinical characteristics by condition (n = 22 in each). Demographic DBT-ST ASG Test p Current disorder DBT-ST ASG Test p Age (years)a 32.27 (10.50) 38.82 (13.55) t(42) = 1.79 .08 Depressive disorder 68.2% 68.2% Χ2(1) = 0.00 1.00 Femaleb 68.2% 63.6% χ2(1) = 0.10 .75 Major depression 59.1% 40.9% Racial background FE 1.00 Dysthymic disorder 4.5% 45.5% Caucasian 95.4% 90.9% NOS 4.5% 0.0% Hispanic ethnicity 4.5% 9.1% FE 1.00 Anxiety disorder 90.9% 86.4% FE 1.00 LGBTQ 18.2% 13.6% FE 1.00 Panic 9.1% 18.2% Single/divorcedc 81.8% 61.2% χ2(1) = 0.30 .30 Agoraphobia 4.5% 9.1% Education U = 221.00 .55 Generalized anxiety 77.3% 54.5% ≥ College graduate 63.6% 72.7% Social phobia 36.4% 36.4% No. BPD symptomsa 2.00 (1.20) 2.41 (1.30) U = 199.00 .30 Specific phobia 13.6% 22.7% Lifetime disorder Obsessive-compulsive 18.2% 4.5% Depressive disorder 95.5% 81.8% FE .35 Posttraumatic stress 13.6% 4.5% Anxiety disorder 72.7% 72.7% χ2(1) = 0.00 1.00 NOS 4.5% 13.6% SUD 40.9% 59.1% χ2(1) = 0.23 .23 SUD 13.6% 0.00% FE .23 Note. DBT-ST = dialectical behavior therapy skills training; ASG = activities-based support group; LGBTQ = Lesbian, Gay, Bisexual, Transgender, Questioning; NOS = not otherwise specified; SUD = substance use disorder; FE = Fisher's Exact test. a M (SD) reported. b Between-condition analysis compares males vs. females. c Between-condition analysis compares married vs. not married. Table options The average adherence score for a random sample of 6 out of 64 DBT-ST sessions was 4.0 (SD = 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. Preliminary analyses A preliminary examination of outcomes showed that, for the entire ITT sample at pretreatment, depression severity moderately correlated with skills use (r = −.32, p < .05) and anxiety severity (r = .31, p < .05). We found no other significant correlations between outcomes (ps > .05). HLM main effects, slope estimates, and standard errors for ITT and completer analyses are included in Table 3. ( Supplementary Fig. 1 shows raw score averages for the ITT sample.) Confound analyses showed that use of psychotropic medications significantly predicted change 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 ( Supplementary Table S2). Table 3. HLM fixed effects and slope estimates for the intent-to-treat (ITT) and the completer analyses by condition. ITT (n = 44) Completer (n = 24) Outcome Phase Effect df F p DBT-ST slope ASG slope df F p DBT-ST slope ASG slope DERS TX Time 1, 124.91 64.49 *** −19.44 (2.40)*** −8.33 (2.48)** 1, 70.18 30.21 *** −19.99 (3.14)*** −8.28 (4.08)* Interaction 1, 123.22 10.42 ** 1, 69.99 30.21 * FU Time 1, 143.03 0.15 .70 4.28 (3.54) −5.62 (3.73) 1, 81.73 0.53 .47 6.44 (4.60) −10.3 0 (5.97) Interaction 1, 143.18 4.15 * 1, 82.67 6.05 * DBT-WCCLa TX Time 1, 115.04 16.18 *** 0.23 (0.05)*** 0.06 (0.05) 1, 67.52 6.85 * 1.63 (0.46)*** 0.34 (0.60) Interaction 1, 115.04 5.87 * 1, 67.52 2.92 .09 FU Time 1, 138.63 1.79 .18 −0.12 (0.07) −0.03 (0.08) 1, 82.78 0.18 .67 −0.58 (0.67) 1.05 (0.87) Interaction 1, 138.63 0.75 .39 1, 82.78 2.23 .14 PHQ-9b TX Time 1, 95.89 45.25 *** −3.99 (0.73)*** −2.74 (0.69)*** 1, 53.00 10.79 ** −3.54 (0.88)*** −1.21 (1.15) Interaction 1, 95.89 1.57 .21 1, 53.00 2.58 .11 FU Time 1, 93.45 2.02 .16 3.18 (1.40)* −0.39 (1.38) 1, 53.00 0.36 .55 2.46 (1.68) −0.79 (2.20) Interaction 1, 93.45 3.29 .07 1, 53.00 1.37 .25 OASISc,d TX Time 1, 92.41 39.29 *** −2.96 (0.43)*** −1.13 (0.49)* 1, 63.95 8.96 ** Interaction 1, 92.41 7.83 ** 1, 63.95 2.73 .10 −0.44 (0.12)*** −0.13 (0.15) FU Time 1, 89.16 0.91 .34 2.04 (0.82)* −0.82 (0.98) 1, 65.71 0.02 .89 0.37 (0.19) −0.33 (0.23) Interaction 1, 89.16 5.08 * 1, 65.71 5.49 * Note. HLM = hierarchical linear model; TX = treatment phase; DBT-ST = dialectical behavior therapy skills training; ASG = activities-based support group; FU = follow-up phase; DERS = difficulties in emotion regulation scale; DBT-WCCL = dialectical behavior therapy ways of coping checklist; PHQ-9 = patient health questionnaire – depression module; OASIS = overall anxiety severity and impairment scale. When necessary completer analyses used transformations using aexponential or csquare-root functions. Only participants who at pretreatment scored over the bPHQ-9 cutoff (nITT = 36; ncompleter = 19) or dOASIS cutoff (nITT = 20; ncompleter = 35) were included in the PHQ-9 and OASIS analyses. *p < .05. **p < .01. ***p < .001. Table options For clinical significance analyses, we computed cutoffs based on Jacobson and Truax's (1991) specifications using DERS data from nonclinical (Fox et al., 2007 and Harrison et al., 2009) and clinical (Fox et al., 2007, Harrison et al., 2009, Salters-Pedneault et al., 2006 and Whiteside et al., 2007) samples and PHQ-9 and OASIS data from nonclinical (Kroenke et al., 2001), depressed (McMillan, Gilbody, & Richards, 2010), and anxious (Norman et al., 2011) samples. For reliable 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 ITT participants who completed the measure both on the phone and at pretreatment (r = .47, p < .01). See Fig. 2 for results. Full-size image (67 K) Fig. 2. Classification of participants for each outcome over time by condition based on clinical significance analyses. Includes only participants who were depressed or anxious based on a aPHQ-9 cutoff (n = 36) or a bOASIS cutoff (n = 35). DBT-ST = dialectical behavior therapy skills training; ASG = activities-based support group. Figure options Change in emotion dysregulation as a function of skills use ITT analyses revealed that during treatment participants in both conditions reported significantly less emotion dysregulation over time but that those in DBT-ST improved significantly more and faster (d = 1.86). We found no significant difference in slopes for participants who were vs. were not 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 trended toward continuing to improve. Completer analyses (n = 24) yielded similar findings, except only ASG completers taking medication significantly improved in emotion regulation during treatment: View the MathML sourceslope estimateASGnomeds=−6.56, SE = 4.49, t(75.53) = −1.46, p = .15; slope estimateASGmeds=−10.57,slope estimateASGmeds=−10.57, SE = 4.87, t(78.11) = −2.17, p = .03. Clinical significance analyses ( Fig. 2) showed a significant difference in recovery from emotion dysregulation favoring DBT-ST at each time point (U2 months = 135.00, U4 months = 99.50, Ufollow-up = 117.00, 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 follow-up, 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 16.0% in DBT-ST and 3.5% in ASG. Completer analyses showed similar results, although the interaction effect during treatment was only a trend ( Table 3). Significant differences in classification (ps < .05) based on clinical significance analyses favored DBT-ST at 4 months (U = 92.00) and at follow-up (U = 108.00; Fig. 2). Skills use significantly mediated the relationship between condition and improvement in emotion regulation ( Table 4). Table 4. Mediation of differences between conditions by skills use. Outcome c (SE) α (SE) β (SE) c′ (SE) ME (SE) 95% CI Explainsa DERS −9.70 (4.80)* 0.20 (0.10)* −30.70 (4.67)*** −3.69 (5.33) −6.10 (3.16) [−12.68, −0.23] 62.31% PHQ-9 −3.12 (1.10)** 0.20 (0.10)* −6.69 (1.07)*** −1.80 (1.01) −1.33 (0.69) [−2.78, −0.05] 42.50% OASIS 0.06 (0.99) 0.20 (0.10)* −3.67 (0.83)*** 0.80 (1.03) −0.73 (0.40) [−1.60, −0.03] 47.63% Note. All analyses used the skills use subscale of the Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) as the mediator and condition as the independent variable. c = coefficient estimate for the fixed effect of condition as a predictor of outcome (i.e., the direct effect); α = coefficient estimate for the fixed effect of condition as a predictor of skills use; β = coefficient estimate for the fixed effect of skills use as a predictor of outcome (with condition added to the model); c′ = coefficient estimate for the fixed effect of condition as a predictor of outcome (with skills use added to the model also called the direct effect); ME = mediated effect (i.e., the estimated indirect effect); 95% CI = confidence interval for the mediated effect calculated by the distribution-of-the-product method (using PRODCLIN software); DERS = difficulties in emotion regulation scale; PHQ-9 = patient health questionnaire – depression module; OASIS = overall anxiety severity and impairment scale. *p < .05. **p < .01. ***p < .001. a Represents the percentage of the total effect (direct + indirect) explained by the mediated effect. Table options We conducted secondary analyses for the ITT sample to explore differential changes between conditions in the different facets of emotion dysregulation (Supplementary Figure S2). During treatment DBT-ST participants increased their goal-directed behavior and use of regulation strategies in emotional situations significantly more than ASG participants: Finteraction(1, 130.14) = 6.03, p < .05; Finteraction(1, 138.16) = 10.90, p < .01; respectively. Gains were maintained at follow-up for both DERS subscales: Finteraction(1, 137.72) = 3.87, p = .05; Finteraction(1, 132.34) = 3.09, p = .08; respectively. For all other subscales, between-condition differences were not significant (ps > .05). Changes in psychopathology Depression severity Thirty-six ITT participants who were clinically depressed at 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, participants in both conditions improved significantly and similarly (d = 0.73). During follow-up, no main effect of time was present, but a trend for an interaction favored ASG. After treatment, DBT-ST participants slightly worsened, reporting a significant increase in depression severity from the end of treatment to follow-up, while ASG participants did not report a significant change. Even with losses in depression gains, DBT-ST participants still reported significant decreases during the study in their depression severity. The effect size for change from pre- to post-treatment was 2.34 in 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 improvement in depression severity during treatment, although the time-by-condition interaction was not significant. At follow-up no significant change for treatment completers was present, suggesting DBT-ST completers maintained their gains ( Table 3). Clinical significance analyses revealed no significant difference in classification between conditions ( Fig. 2). Use of skills significantly mediated the relationship between condition and change in depression severity ( Table 4). Anxiety severity Thirty-five ITT participants who were clinically anxious at pretreatment based on a score above the clinical cutoff (7) on the OASIS were analyzed for differential changes in anxiety severity. During treatment, participants in both conditions reported a significant decrease in their anxiety severity, but DBT-ST participants improved significantly faster (d = 1.37). Follow-up analyses showed no significant effect of time but revealed a significant interaction favoring 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 still reported a significant decrease in their anxiety severity from pretreatment to the end of the study. The effect size for changes from pre- to post-treatment was 1.34 in 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 (although not reaching) significance during treatment ( Table 3). Clinical significance analyses revealed no significant difference in classification between conditions for anxiety ( Fig. 2). Because the overall main effect of condition was not significant for anxiety severity, we followed Kramer et al.'s (2002) guidelines and added the interaction between skills use and condition to the mediation model. We 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 differentially by condition. Feasibility of treatment and research protocol More participants dropped treatment in ASG (n = 13) than DBT-ST (n = 7), a nonsignificant difference, χ2(1, 44) = 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 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 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 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 conducted independent HLM analyses including only compliant ITT participants (13 in DBT-ST, 11 in ASG) and found similar results with two exceptions: (a) compliant ASG participants did not report significant reductions over time in 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).