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Trial record 17 of 2665 for:    "Depressive Disorder" [DISEASE] AND depressive symptoms

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

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ClinicalTrials.gov Identifier: NCT01330485
Recruitment Status : Completed
First Posted : April 7, 2011
Last Update Posted : April 10, 2019
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Matthias Berking, Ph.D., Friedrich-Alexander-Universität Erlange-Nürnberg

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).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Affect Regulation Training Behavioral: Common Factor Control Condition Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Group (3 groups) x time
Masking: Single (Outcomes Assessor)
Masking Description: Assessors were blinded to study conditions.
Primary Purpose: Treatment
Official Title: Deficits in Emotion Regulation Skills as a Maintaining Factor in Major Depressive Disorder
Study Start Date : November 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Affect Regulation Training
Affect Regulation Training as described in Berking & Whitley, 2014.
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).
Other Name: ART

Active Comparator: Common Factor Control Condition (CFC)
Common factor based therapy control condition
Behavioral: Common Factor Control Condition
The CFC is an active treatment condition designed to control for unspecific effects of psychotherapeutic interventions.
Other Name: CFC

No Intervention: Waitlist Control Condition
Wait List Control



Primary Outcome Measures :
  1. Change in depressive symptoms [ Time Frame: 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 ]
    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


Secondary Outcome Measures :
  1. Emotion regulation skills [ Time Frame: 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 ]
    Emotion regulation skills as assessed with the Emotion Regulation Skills Questionnaire


Other Outcome Measures:
  1. General psychopathological symptom load [ Time Frame: 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 ]
    General psychopathological symptom load as assessed with the Brief Symptom Inventory

  2. Course of depressive symptoms during individual CBT after ART/CFC/WLC. [ Time Frame: Pre to post individual CBT (estimated up to 2 years, depending upon the patient's specific needs) ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01330485


Locations
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Germany
Philipps-University of Marburg
Marburg, Hessen, Germany, 35032
Aus- und Weiterbildungszentrum für Klinische Verhaltenstherapie
Kassel, Germany, 34119
University of Mainz
Mainz, Germany, D-55122
Sponsors and Collaborators
Friedrich-Alexander-Universität Erlange-Nürnberg
German Research Foundation
Investigators
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Principal Investigator: Matthias Berking, Prof. Dr. Friedrich-Alexander-University Erlangen-Nuremberg

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Matthias Berking, Ph.D., Prof. Dr., Friedrich-Alexander-Universität Erlange-Nürnberg
ClinicalTrials.gov Identifier: NCT01330485     History of Changes
Other Study ID Numbers: BE4510/3-1
First Posted: April 7, 2011    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified IPD will be made available to other researchers upon reguest.
Supporting Materials: Informed Consent Form (ICF)
Analytic Code
Time Frame: From January 2018 to January 2028
Access Criteria: Credible and legitimate reason for request

Keywords provided by Matthias Berking, Ph.D., Friedrich-Alexander-Universität Erlange-Nürnberg:
depression
emotion regulation
affect regulation
skills
randomized controlled trial
mediation

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