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

Friedrich-Alexander-Universität Erlangen-Nürnberg218 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

218

Conditions

Major Depressive Disorder

Interventions

Affect Regulation TrainingBEHAVIORAL

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).

Common Factor Control ConditionBEHAVIORAL

The CFC is an active treatment condition designed to control for unspecific effects of psychotherapeutic interventions.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Philipps-University of Marburg

Marburg, Hesse, Germany

Aus- und Weiterbildungszentrum für Klinische Verhaltenstherapie

Kassel, Germany

University of Mainz

Mainz, Germany

Outcomes

Primary Outcomes

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

Time frame: 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 Outcomes

Emotion regulation skills

Emotion regulation skills as assessed with the Emotion Regulation Skills Questionnaire

Time frame: 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

Data from ClinicalTrials.gov

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