Condition category
Mental and Behavioural Disorders
Date applied
30/03/2011
Date assigned
07/07/2011
Last edited
07/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Matthias Berking

ORCID ID

Contact details

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

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 measures

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

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

http://www.snf.ch/E/Pages/default.aspx

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, SNF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

Results - basic reporting

Publication summary

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.

Publication citations

Additional files

Editorial Notes