Deficits in Emotion Regulation Skills as a Maintaining Factor in Major Depressive Disorder
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| First Received Date ICMJE | April 4, 2011 | ||||
| Last Updated Date | May 3, 2013 | ||||
| Start Date ICMJE | November 2010 | ||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
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. |
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| Change History | Complete list of historical versions of study NCT01330485 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE |
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 ] | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Deficits in Emotion Regulation Skills as a Maintaining Factor in Major Depressive Disorder | ||||
| Official Title ICMJE | Deficits in Emotion Regulation Skills as a Maintaining Factor in Major Depressive Disorder | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Major Depressive Disorder | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 150 | ||||
| Estimated Completion Date | June 2014 | ||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01330485 | ||||
| Other Study ID Numbers ICMJE | BE4510/3-1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Prof. Dr. Matthias Berking, Philipps University Marburg Medical Center | ||||
| Study Sponsor ICMJE | Philipps University Marburg Medical Center | ||||
| Collaborators ICMJE | German Research Foundation | ||||
| Investigators ICMJE |
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| Information Provided By | Philipps University Marburg Medical Center | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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