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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330485
• Other study ID #: BE4510/3-1
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Est. completion date: September 2014

Study information

• Verified date: April 2019
• Source: Friedrich-Alexander-Universität Erlange-Nürnberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: September 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

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).
• Common Factor Control Condition
The CFC is an active treatment condition designed to control for unspecific effects of psychotherapeutic interventions.

Locations

Country	Name	City	State
Germany	Aus- und Weiterbildungszentrum für Klinische Verhaltenstherapie	Kassel
Germany	University of Mainz	Mainz
Germany	Philipps-University of Marburg	Marburg	Hessen

Sponsors (2)

Lead Sponsor	Collaborator
Friedrich-Alexander-Universität Erlange-Nürnberg	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Course of depressive symptoms during individual CBT after ART/CFC/WLC.	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)
Primary	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	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