Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10104020-2
Study information
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
Acronym
ERTMDD
Study hypothesis
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
Vogelsberg Clinic (Germany), March 2008
Study design
Prospective single center randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase IV
Drug names
Primary outcome measure
Beck Depression Inventory (BDI; German version: Hautzinger, Bailer, Worall, & Keller, 1995) as assessed pre- and post treatment
Secondary outcome measures
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
Overall trial start date
01/04/2008
Overall trial end date
01/06/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Participant 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)
Recruitment start date
01/04/2008
Recruitment end date
01/06/2011
Locations
Countries of recruitment
Germany
Trial participating centre
University of Marburg
Marburg
35032
Germany
Sponsor information
Organisation
Swiss National Science Foundation (Switzerland)
Sponsor details
Wildhainweg 3
P.O. Box 8232
Bern
CH-3001
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
Swiss National Science Foundation (PZ00P1-121576/1)
Alternative name(s)
Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNSF, FNS, SNF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
Switzerland
Funder name
University of Lüneburg, Germany
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Marburg, Germany
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Vogelsberg Clinic, Germany
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. Berking, M. (2010). Training Emotionaler Kompetenzen, 2. Aufl. Heidelberg: Springer.
2. Berking, M., Meier, C. & Wupperman, P. (2010). Enhancing emotion-regulation skills in police officers - Results of a controlled study. Behavior Therapy, 41, 329-339.
3. Berking, M., Wupperman, P., Reichardt, A., Pejic, T., Dippel, A., & Znoj, H. (2008). General emotion-regulation skills as a treatment target in psychotherapy. Behaviour Research and Therapy, 46, 1230-1237.
4. Berking, M., & Znoj, H. (2008). Entwicklung und Validierung eines Fragebogens zur standardisierten Selbsteinschätzung emotionaler Kompetenzen (SEK-27). [Development and Validation of a Self-Report Measure for the Assessment of Emotion-regulation Skills (SEK-27).] Zeitschrift für Psychiatrie, Psychologie und Psychotherapie, 56, 141-152.