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

This study is currently recruiting participants.
Verified May 2013 by Philipps University Marburg Medical Center
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Prof. Dr. Matthias Berking, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT01330485
First received: April 4, 2011
Last updated: May 3, 2013
Last verified: May 2013

April 4, 2011
May 3, 2013
November 2010
November 2013   (final data collection date for primary outcome measure)
change in depressive symptoms (Beck Depression Inventory, BDI-II; Hamilton Rating Scale for Depression, HRSD) [ Time Frame: pre/post/follow-up design, including 10 points of measurement (before/during/after group based intervention and first 16 weeks of iCBT-D) ] [ Designated as safety issue: No ]
Investigating reciprocal associations between Depressive Symptom Severity (DSS) and General Emotion Regulation Skills (GEMS). Clarifying whether experimentally enhancing GEMS reduces DSS and whether fostering GEMS enhances outcome of subsequent individual CBT for depression (iCBT-D) on DSS.
change in depressive symptoms (BDI-II, HRSD) [ Time Frame: pre/post/follow-up design, including 10 points of measurement (before/during/after group based intervention and first 16 weeks of iCBT-D) ] [ Designated as safety issue: No ]
Investigating reciprocal associations between Depressive Symptom Severity (DSS) and General Emotion Regulation Skills (GEMS). Clarifying whether experimentally enhancing GEMS reduces DSS and whether fostering GEMS enhances outcome of subsequent individual CBT for depression (iCBT-D) on DSS.
Complete list of historical versions of study NCT01330485 on ClinicalTrials.gov Archive Site
change in other indicators of mental health (psychopathological symptom load, well-being, functional impairment) [ Time Frame: pre/post/follow-up design, including 10 points of measurement (before/during/after group based intervention and first 16 weeks of iCBT-D) ] [ Designated as safety issue: No ]
testing associations of GEMS with other indicators of mental health than DSS
Same as current
experimental evaluation of the affect regulation training and assessment of hair cortisol concentrations [ Time Frame: before and after affect regulation training (experiment); hair cortisol additionally after completion of individual cognitive behavioral therapy for depression ] [ Designated as safety issue: No ]
Not Provided
 
Deficits in Emotion Regulation Skills as a Maintaining Factor in Major Depressive Disorder
Deficits in Emotion Regulation Skills as a Maintaining Factor in Major Depressive Disorder

Nested within a longitudinal study investigating emotion regulation skills and subsequent depressive symptoms in major depressive disorder, the effectiveness of a systematic affect regulation training (ART; Berking, 2010) is evaluated in a randomized controlled trial.

Research suggests that deficits in general emotion regulation skills (GEMS; e.g., the abilities to be aware of, understand, accept, tolerate and modify negative emotions) help maintain symptoms in depression, as well as in other mental disorders often co-occurring with depression. Therefore, systematically targeting these deficits can be hypothesized to enhance efficacy and efficiency of current treatments for this severe and highly prevalent disorder. However, at this point there is a lack of prospective studies that investigate the causal effects of a broad range of potentially relevant GEMS on depression, evaluate the effects of systematically enhancing these skills with specific interventions, and investigate whether the level of comorbid symptom load moderates the importance of GEMS in depression. Therefore, we assess GEMS, depressive symptom severity (DSS) and comorbid symptom load in 150 individuals seeking treatment for major depressive disorder (MDD) across multiple assessment points, and clarify causal pathways between GEMS and DSS. Nested within the longitudinal design, prior to individual cognitive behavioral therapy for depression (iCBT-D) participants will be randomly assigned either to (a) a group-based training of GEMS (ART = affect regulation training; Berking, 2010), (b) an active treatment condition designed to control for unspecific effects of psychotherapeutic interventions (i.e., common-factor-based-treatment control condition, CFT-C), or (c) a wait-list-control condition (WLC). Potential effects of systematically enhancing GEMS on DSS will be assessed during an 8-week pre-iCBT-D interval (stand-alone effects) and during the first four months of subsequent iCBT-D (augmentation effects). Assessment will include retrospective self-ratings, observer-based ratings, and ecological momentary assessment (EMA). Thus, in addition to providing important information on the relevance of GEMS for the maintenance of depression, the study will help evaluate different methodological approaches of identifying deficits in GEMS.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
  • Behavioral: ART
    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).
  • Behavioral: CFT-C
    The CFT-C is an active treatment condition designed to control for unspecific effects of psychotherapeutic interventions.
  • Behavioral: i-CBT-D (individual cognitive therapy for depression)
    Individual cognitive therapy for depression (iCBT-D) will cover a 4-month period with 16 (weekly) sessions (à 50 minutes) in total. Treatment will follow a manualized protocol that is based upon procedures developed by Hautzinger (2003) and that includes: (1) psychoeducation on depression, introducing the CBT-based treatment rationale; (2) behavioral activation; (3) cognitive restructuring, training of social skills, stress reduction and relapse prevention.
  • Experimental: ART
    Affect Regulation Training
    Interventions:
    • Behavioral: ART
    • Behavioral: i-CBT-D (individual cognitive therapy for depression)
  • Active Comparator: CFT-C
    common factor based therapy control condition
    Interventions:
    • Behavioral: CFT-C
    • Behavioral: i-CBT-D (individual cognitive therapy for depression)
  • WLC
    wait list control
    Intervention: Behavioral: i-CBT-D (individual cognitive therapy for depression)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
June 2014
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Matthias Berking, Prof. Dr. +49 (0)6421 282 4050 berking@staff.uni-marburg.de
Germany
 
NCT01330485
BE4510/3-1
No
Prof. Dr. Matthias Berking, Philipps University Marburg Medical Center
Philipps University Marburg Medical Center
German Research Foundation
Principal Investigator: Matthias Berking, Prof. Dr. Philipps University Marburg Medical Center
Philipps University Marburg Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP