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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 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: November 13, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Behavioral: ART
Behavioral: CFT-C
Behavioral: i-CBT-D (individual cognitive therapy for depression)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Deficits in Emotion Regulation Skills as a Maintaining Factor in Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: November 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ART
Affect Regulation Training
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: 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.
Active Comparator: CFT-C
common factor based therapy control condition
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.
WLC
wait list control
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330485

Contacts
Contact: Matthias Berking, Prof. Dr. +49 (0)6421 282 4050 berking@staff.uni-marburg.de

Locations
Germany
Philipps-University of Marburg Recruiting
Marburg, Hessen, Germany, 35032
Principal Investigator: Matthias Berking, Prof. Dr.         
University of Mainz Recruiting
Mainz, Germany, D-55122
Contact: Wolfgang Hiller, Prof. Dr.    +49 (0)6131 3939200;    hiller@mail.uni-mainz.de   
Sub-Investigator: Wolfgang Hiller, Prof. Dr.         
Sponsors and Collaborators
Philipps University Marburg Medical Center
German Research Foundation
Investigators
Principal Investigator: Matthias Berking, Prof. Dr. Philipps University Marburg Medical Center
  More Information

No publications provided by Philipps University Marburg Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Matthias Berking, Prof. Dr., Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT01330485     History of Changes
Other Study ID Numbers: BE4510/3-1
Study First Received: April 4, 2011
Last Updated: November 13, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 18, 2014