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

Not Applicable

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT01330485
• Lead Sponsor: Friedrich-Alexander-Universität Erlangen-Nürnberg

Brief Summary

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

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 Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-04-04
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-07
• Primary Completion: 2014-04
• Study Completion: 2014-09
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-08
• Last Update Posted: 2019-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Change in depressive symptoms	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	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

Secondary Outcome Measures

Name	Time	Method
Emotion regulation skills	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	Emotion regulation skills as assessed with the Emotion Regulation Skills Questionnaire

Trial Locations

Locations (3)

Philipps-University of Marburg; 🇩🇪 Marburg, Hessen, Germany

Aus- und Weiterbildungszentrum für Klinische Verhaltenstherapie; 🇩🇪 Kassel, Germany

University of Mainz; 🇩🇪 Mainz, Germany