Deficits in Emotion Regulation Skills as a Maintaining Factor in Major Depressive Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Major Depressive Disorder
- Sponsor
- Friedrich-Alexander-Universität Erlangen-Nürnberg
- Enrollment
- 218
- Locations
- 3
- Primary Endpoint
- Change in depressive symptoms
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Matthias Berking, Ph.D.
Prof. Dr.
Friedrich-Alexander-Universität Erlangen-Nürnberg
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in depressive symptoms
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
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 Outcomes
- 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)