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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Affect Regulation Training | Experimental | Affect Regulation Training as described in Berking & Whitley, 2014. |
|
| Common Factor Control Condition (CFC) | Active Comparator | Common factor based therapy control condition |
|
| Waitlist Control Condition | No Intervention | Wait List Control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Affect Regulation Training | Behavioral | 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). |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| General psychopathological symptom load | General psychopathological symptom load as assessed with the Brief Symptom Inventory | 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 |
| Course of depressive symptoms during individual CBT after ART/CFC/WLC. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Berking, Prof. Dr. | Friedrich-Alexander-University Erlangen-Nuremberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philipps-University of Marburg | Marburg | Hesse | 35032 | Germany | ||
| Aus- und Weiterbildungszentrum für Klinische Verhaltenstherapie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40907712 | Derived | Eichler E, Hager M, Baeuml J, Berking M. Emotion regulation as mechanism of change in the treatment of depression - A latent change score analysis. J Affect Disord. 2026 Jan 1;392:120205. doi: 10.1016/j.jad.2025.120205. Epub 2025 Sep 2. | |
| 31465443 | Derived | Berking M, Eichler E, Luhmann M, Diedrich A, Hiller W, Rief W. Affect regulation training reduces symptom severity in depression - A randomized controlled trial. PLoS One. 2019 Aug 29;14(8):e0220436. doi: 10.1371/journal.pone.0220436. eCollection 2019. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
Deidentified IPD will be made available to other researchers upon reguest.
From January 2018 to January 2028
Credible and legitimate reason for request
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| D000080103 | Emotional Regulation |
| D017008 | Negotiating |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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Group (3 groups) x time
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Assessors were blinded to study conditions.
|
| Common Factor Control Condition | Behavioral | The CFC is an active treatment condition designed to control for unspecific effects of psychotherapeutic interventions. |
|
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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 |
| Pre to post individual CBT (estimated up to 2 years, depending upon the patient's specific needs) |
| Kassel |
| 34119 |
| Germany |
| University of Mainz | Mainz | D-55122 | Germany |
| 24467807 | Derived | Ehret AM, Kowalsky J, Rief W, Hiller W, Berking M. Reducing symptoms of major depressive disorder through a systematic training of general emotion regulation skills: protocol of a randomized controlled trial. BMC Psychiatry. 2014 Jan 27;14:20. doi: 10.1186/1471-244X-14-20. |
| All study files | View IPD |
| D001519 |
| Behavior |
| D000068356 | Self-Control |
| D012919 | Social Behavior |
| D003142 | Communication |