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

NCT01330485 | Completed

• 1 other identifier: BE4510/3-1
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 3

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).

Conditions

Major Depressive Disorder

Keywords

depression; emotion regulation; affect regulation; skills; randomized controlled trial; mediation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Other Outcomes (2)

• 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

• 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)

Study Arms (3)

Affect Regulation Training

EXPERIMENTAL

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

Behavioral: Affect Regulation Training

Common Factor Control Condition (CFC)

ACTIVE COMPARATOR

Common factor based therapy control condition

Behavioral: Common Factor Control Condition

Waitlist Control Condition

NO INTERVENTION

Wait List Control

Interventions

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).

Also known as: ART

Affect Regulation Training

Common Factor Control Condition BEHAVIORAL

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

Also known as: CFC

Common Factor Control Condition (CFC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of MDD according to DSM-IV criteria as the primary diagnosis
• age 18 and above
• sufficient German language skills

You may not qualify if:

• 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

Sponsors & Collaborators

• Friedrich-Alexander-Universität Erlangen-Nürnberg: lead
• German Research Foundation: collaborator

Study Sites (3)

Philipps-University of Marburg

Marburg, Hesse, 35032, Germany

Location

Aus- und Weiterbildungszentrum für Klinische Verhaltenstherapie

Kassel, 34119, Germany

Location

University of Mainz

Mainz, D-55122, Germany

Location

Related Publications (3)

• 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.

  PMID: 40907712 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.

  PMID: 31465443 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.

  PMID: 24467807 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Emotional Regulation; Negotiating

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Self-Control; Social Behavior; Communication

Study Officials

• Matthias Berking, Prof. Dr.

  Friedrich-Alexander-University Erlangen-Nuremberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors were blinded to study conditions.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Group (3 groups) x time

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 7, 2011
• Study Start: November 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 10, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, ANALYTIC CODE
• Time Frame: From January 2018 to January 2028
• Access Criteria: Credible and legitimate reason for request

Locations

DE (3)