Clinical trial NCT01330485: 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
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: depression
emotion regulation
affect regulation
skills
randomized controlled trial
mediation
Lead sponsor: Friedrich-Alexander-Universität Erlangen-Nürnberg
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2011-04-07
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Group (3 groups) x time
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in depressive symptoms
timeFrame: 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 outcomes:
measure: Emotion regulation skills
timeFrame: 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 outcomes:
measure: General psychopathological symptom load
timeFrame: 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
measure: Course of depressive symptoms during individual CBT after ART/CFC/WLC.
timeFrame: Pre to post individual CBT (estimated up to 2 years, depending upon the patient's specific needs)
Locations:
city: Marburg
country: Germany
facility: Philipps-University of Marburg
state: Hessen
city: Kassel
country: Germany
facility: Aus- und Weiterbildungszentrum für Klinische Verhaltenstherapie
city: Mainz
country: Germany
facility: University of Mainz
Study officials:
affiliation: Friedrich-Alexander-University Erlangen-Nuremberg
name: Matthias Berking, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.