Major Depressive Disorder
Conditions
Keywords
depression, emotion regulation, affect regulation, skills, randomized controlled trial, mediation
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.
Interventions
BEHAVIORALAffect Regulation Training
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).
BEHAVIORALCommon Factor Control Condition
The CFC is an active treatment condition designed to control for unspecific effects of psychotherapeutic interventions.
Sponsors
German Research Foundation
Friedrich-Alexander-Universität Erlangen-Nürnberg
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors were blinded to study conditions.
Intervention model description
Group (3 groups) x time
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| General psychopathological symptom load | 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 | General psychopathological symptom load as assessed with the Brief Symptom Inventory |
| Course of depressive symptoms during individual CBT after ART/CFC/WLC. | Pre to post individual CBT (estimated up to 2 years, depending upon the patient's specific needs) | Course of depressive symptoms during individual CBT after ART/CFC/WLC. Testing the hypothesis that fostering emotion regulation skills may enhance the efficacy of subsequent individual cognitive behavioral therapy for depression |
Countries
Germany
Outcome results
None listed