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

Friedrich-Alexander-Universität Erlangen-Nürnberg

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Behavioral: Common Factor Control Condition; Behavioral: Affect Regulation Training

Study type: Interventional

Funder types: Other

Identifiers

NCT01330485

BE4510/3-1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 218 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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218 participants in 3 patient groups

Affect Regulation Training

Experimental group

Description:

Affect Regulation Training as described in Berking \& Whitley, 2014.

Treatment:

Behavioral: Affect Regulation Training

Common Factor Control Condition (CFC)

Active Comparator group

Description:

Common factor based therapy control condition

Treatment:

Behavioral: Common Factor Control Condition

Waitlist Control Condition

No Intervention group

Description:

Wait List Control