Deficits in Emotion Regulation Skills as a Maintaining Factor in Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Affect Regulation Training
Common Factor Control Condition
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, emotion regulation, affect regulation, skills, randomized controlled trial, mediation
Eligibility 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
Sites / Locations
- Philipps-University of Marburg
- Aus- und Weiterbildungszentrum für Klinische Verhaltenstherapie
- University of Mainz
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Affect Regulation Training
Common Factor Control Condition (CFC)
Waitlist Control Condition
Arm Description
Affect Regulation Training as described in Berking & Whitley, 2014.
Common factor based therapy control condition
Wait List Control
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Emotion regulation skills
Emotion regulation skills as assessed with the Emotion Regulation Skills Questionnaire
Full Information
NCT ID
NCT01330485
First Posted
April 4, 2011
Last Updated
April 8, 2019
Sponsor
Friedrich-Alexander-Universität Erlangen-Nürnberg
Collaborators
German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01330485
Brief Title
Deficits in Emotion Regulation Skills as a Maintaining Factor in Major Depressive Disorder
Official Title
Deficits in Emotion Regulation Skills as a Maintaining Factor in Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Friedrich-Alexander-Universität Erlangen-Nürnberg
Collaborators
German Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression, emotion regulation, affect regulation, skills, randomized controlled trial, mediation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Group (3 groups) x time
Masking
Outcomes Assessor
Masking Description
Assessors were blinded to study conditions.
Allocation
Randomized
Enrollment
218 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Affect Regulation Training
Arm Type
Experimental
Arm Description
Affect Regulation Training as described in Berking & Whitley, 2014.
Arm Title
Common Factor Control Condition (CFC)
Arm Type
Active Comparator
Arm Description
Common factor based therapy control condition
Arm Title
Waitlist Control Condition
Arm Type
No Intervention
Arm Description
Wait List Control
Intervention Type
Behavioral
Intervention Name(s)
Affect Regulation Training
Other Intervention Name(s)
ART
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Common Factor Control Condition
Other Intervention Name(s)
CFC
Intervention Description
The CFC is an active treatment condition designed to control for unspecific effects of psychotherapeutic interventions.
Primary Outcome Measure Information:
Title
Change in depressive symptoms
Description
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
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
Secondary Outcome Measure Information:
Title
Emotion regulation skills
Description
Emotion regulation skills as assessed with the Emotion Regulation Skills Questionnaire
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
Other Pre-specified Outcome Measures:
Title
General psychopathological symptom load
Description
General psychopathological symptom load as assessed with the Brief Symptom Inventory
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
Title
Course of depressive symptoms during individual CBT after ART/CFC/WLC.
Description
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
Time Frame
Pre to post individual CBT (estimated up to 2 years, depending upon the patient's specific needs)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Berking, Prof. Dr.
Organizational Affiliation
Friedrich-Alexander-University Erlangen-Nuremberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philipps-University of Marburg
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35032
Country
Germany
Facility Name
Aus- und Weiterbildungszentrum für Klinische Verhaltenstherapie
City
Kassel
ZIP/Postal Code
34119
Country
Germany
Facility Name
University of Mainz
City
Mainz
ZIP/Postal Code
D-55122
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified IPD will be made available to other researchers upon reguest.
IPD Sharing Time Frame
From January 2018 to January 2028
IPD Sharing Access Criteria
Credible and legitimate reason for request
Citations:
PubMed Identifier
31465443
Citation
Berking M, Eichler E, Luhmann M, Diedrich A, Hiller W, Rief W. Affect regulation training reduces symptom severity in depression - A randomized controlled trial. PLoS One. 2019 Aug 29;14(8):e0220436. doi: 10.1371/journal.pone.0220436. eCollection 2019.
Results Reference
derived
PubMed Identifier
24467807
Citation
Ehret AM, Kowalsky J, Rief W, Hiller W, Berking M. Reducing symptoms of major depressive disorder through a systematic training of general emotion regulation skills: protocol of a randomized controlled trial. BMC Psychiatry. 2014 Jan 27;14:20. doi: 10.1186/1471-244X-14-20.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://osf.io/426pd
Available IPD/Information Type
All study files
Available IPD/Information URL
https://osf.io/uhwnb
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Deficits in Emotion Regulation Skills as a Maintaining Factor in Major Depressive Disorder
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