Evaluating the effectiveness of an adjunctive Emotion Regulation Training during inpatient treatment for Major Depressive Disorder

ISRCTN	ISRCTN40594308
DOI	https://doi.org/10.1186/ISRCTN40594308
Protocol serial number	10104020-2
Sponsor	Swiss National Science Foundation (Switzerland)
Funders	Swiss National Science Foundation (PZ00P1-121576/1), University of Lüneburg, Germany, University of Marburg, Germany, Vogelsberg Clinic, Germany

Submission date: 30/03/2011
Registration date: 07/07/2011
Last edited: 07/07/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Matthias Berking
Scientific

University of Marburg
Institute of Psychology
Department of Clinical Psychology and Psychotherapy
Gutenbergstraße 18
Marburg
35032
Germany

Study information

Primary study design	Interventional
Study design	Prospective single center randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Evaluating the effects of integrating an Emotion Regulation Training in cognitive behavioral psychotherapeutic inpatient treatment for Major Depressive Disorder on the reduction of depressive symptoms - a randomized controlled trial
Study acronym	ERTMDD
Study objectives	Including an intensive emotion regulation training in inpatient cognitive-behavioral psychotherapeutic treatment (CBT) for depression enhances the treatment's effects on symptoms of depression
Ethics approval(s)	Vogelsberg Clinic (Germany), March 2008
Health condition(s) or problem(s) studied	Major depressive disorder as defined by DSM IV criteria
Intervention	1. Cognitive Behavioural Therapy (CBT) + Emotion Regulation Training (ERT): ERT is an abbreviated (5 x 1.5 hs) version of the "Affect Regulation Training" developed by Berking (2010; German: Training emotionaler Kompetenzen). 2. The training aims to enhance emotion regulation skills with the help of a variety of methods including relaxation, acceptance of emotions, compassionate self-support, behavior analysis and emotion-focused problem solving 3. It will be delivered in 1.5 hour sessions two times a week during the second, third and forth week of the inpatient treatment 4. Control condition: CBT-based treatment as usual including behavioral activation and cognitive restructuring
Intervention type	Other
Primary outcome measure(s)	Beck Depression Inventory (BDI; German version: Hautzinger, Bailer, Worall, & Keller, 1995) as assessed pre- and post treatment
Key secondary outcome measure(s)	1. Emotion Regulation Skills Questionnaire (ERSQ; German version: Berking & Znoj, 2008) as assessed pre- and post treatment 2. BDI scores as assessed at pre-treatment and at a 6-month follow-up 3. BDI scores as assessed at pre-treatment and at a 12-month follow-up 4. ERSQ scores as assessed at pretreatment and at a 6-month follow-up 5. ERSQ scores as assessed at pre-treatment and at a 12-month follow-up
Completion date	01/06/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	500
Key inclusion criteria	1. Diagnosis of Major Depressive Disorder according to DSM-IV criteria 2. Age: 18 or above 3. Ability and willingness to provide informed consent 4. Anticipated treatment length of six weeks or above
Key exclusion criteria	1. High risk of suicide 2. Co-occurring psychotic 3. Bi-polar disorders 4. Alcohol/substance dependence within the past six months 5. Insufficient German language skills (assessment and treatment will be in German)
Date of first enrolment	01/04/2008
Date of final enrolment	01/06/2011

Locations

Countries of recruitment

Germany

Study participating centre

University of Marburg

Marburg
35032
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2008		Yes	No
Results article	results	01/09/2010		Yes	No
Other publications		17/04/2008		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes