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

April 8, 2019 updated by: Matthias Berking, Ph.D., Friedrich-Alexander-Universität Erlangen-Nürnberg
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Kassel, Germany, 34119
        • Aus- und Weiterbildungszentrum für Klinische Verhaltenstherapie
      • Mainz, Germany, D-55122
        • University of Mainz
    • Hessen
      • Marburg, Hessen, Germany, 35032
        • Philipps-University of Marburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Affect Regulation Training
Affect Regulation Training as described in Berking & Whitley, 2014.
Behavioral: 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).
Other Names:
  • ART
Active Comparator: Common Factor Control Condition (CFC)
Common factor based therapy control condition
Behavioral: Common Factor Control Condition
The CFC is an active treatment condition designed to control for unspecific effects of psychotherapeutic interventions.
Other Names:
  • CFC
No Intervention: Waitlist Control Condition
Wait List Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotion regulation skills
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
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
General psychopathological symptom load
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
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.
Time Frame: 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
Pre to post individual CBT (estimated up to 2 years, depending upon the patient's specific needs)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Friedrich-Alexander-Universität Erlangen-Nürnberg

Collaborators

German Research Foundation

Investigators

  • Principal Investigator: Matthias Berking, Prof. Dr., Friedrich-Alexander-University Erlangen-Nuremberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

April 4, 2011

First Submitted That Met QC Criteria

April 5, 2011

First Posted (Estimate)

April 7, 2011

Study Record Updates

Last Update Posted (Actual)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BE4510/3-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified IPD will be made available to other researchers upon reguest.

IPD Sharing Time Frame

From January 2018 to January 2028

IPD Sharing Access Criteria

Credible and legitimate reason for request

IPD Sharing Supporting Information Type

  • ICF
  • ANALYTIC_CODE

Study Data/Documents

  1. Individual Participant Data Set
  2. All study files

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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