Deficits in Emotion Regulation Skills as a Maintaining Factor in Major Depressive Disorder

Study Overview
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Brief Summary
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The primary aim of the study is to evaluate the efficacy of a systematic training of general affect regulation skills (ART) on the reduction of depressive symptom in individuals meeting criteria for major depressive disorder (MDD).

Detailed Description
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Deficits in general emotion regulation skills have been shown to be associated with various mental disorders. Thus, general affect-regulation training has been proposed as promising transdiagnostic approach to the treatment of psychopathology. In the present study, we aimed to evaluate the efficacy of a general affect-regulation as a stand-alone, group-based treatment for depression. For this purpose, we randomly assigned 218 individuals who met criteria for major depressive disorder (MDD) to the Affect Regulation Training (ART), to a waitlist control condition (WLC), or to a condition controlling for common factors (CFC). The primary outcome was the course of depressive symptom severity as assessed with the Hamilton Rating Scale for Depression and the Beck Depression Inventory. Differences between groups will be analyzed with the help of multi-level analyses. To clarify mechanisms of change we will test whether changes in emotion regulation skills will mediate potential differences between conditions regarding change of depressive symptoms. As secondary goal, the study will try and clarify whether participating in ART might augment the efficacy of subsequent individual cognitive-behavioral therapy.

Official Title
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Deficits in Emotion Regulation Skills as a Maintaining Factor in Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Affect Regulation Training
* Behavioral: Common Factor Control Condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of MDD according to DSM-IV criteria as the primary diagnosis age 18 and above sufficient German language skills Exclusion Criteria: high risk of suicide indication of substantial secondary gain currently in psychotherapeutic treatment with an institution/professional other than those involved in the study co-occurring psychotic, bi-polar, and/or substance disorders organic brain disorder(s), severe medical condition, and/or severe cognitive impairment that impedes ability to participate in the study or treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Group (3 groups) x time
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Affect Regulation Training<br>Affect Regulation Training as described in Berking & Whitley, 2014. | Behavioral: Affect Regulation Training<br>* The ART is a transdiagnostic, group-based intervention that has been developed to explicitly target emotion regulation skills (e.g., the abilities to be aware of, understand, accept, tolerate and modify negative emotions).<br>* Other names: ART;|
| Active Comparator: Common Factor Control Condition (CFC)<br>Common factor based therapy control condition | Behavioral: Common Factor Control Condition<br>* The CFC is an active treatment condition designed to control for unspecific effects of psychotherapeutic interventions.<br>* Other names: CFC;|
| No Intervention: Waitlist Control Condition<br>Wait List Control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive symptoms | Change in depressive symptoms as assessed in Beck Depression Inventory (BDI-II) and Hamilton Rating Scale for Depression (HRSD) and aggregated to a composite score is possible | Pre to post ART, CFC or WLC; hence covering the ten week time period from the first assessment point (prior to randomization) to the assessment point 10 weeks later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotion regulation skills | Emotion regulation skills as assessed with the Emotion Regulation Skills Questionnaire | Pre to post ART, CFC or WLC; hence covering the ten week time period from the first assessment point (prior to randomization) to the assessment point 10 weeks later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, emotion regulation, affect regulation, skills, randomized controlled trial, mediation