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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-09-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Group (3 groups) x time

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Assessors were blinded to study conditions.

Study Groups

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Affect Regulation Training

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

Group Type EXPERIMENTAL

Affect Regulation Training

Intervention Type 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).

Common Factor Control Condition (CFC)

Common factor based therapy control condition

Group Type ACTIVE_COMPARATOR

Common Factor Control Condition

Intervention Type BEHAVIORAL

The CFC is an active treatment condition designed to control for unspecific effects of psychotherapeutic interventions.

Waitlist Control Condition

Wait List Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Affect 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).

Intervention Type BEHAVIORAL

Common Factor Control Condition

The CFC is an active treatment condition designed to control for unspecific effects of psychotherapeutic interventions.

Intervention Type BEHAVIORAL

Other Intervention Names

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ART CFC

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No