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 |
| Secondary identifying numbers | 10104020-2 |
- 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
Scientific
University of Marburg
Institute of Psychology
Department of Clinical Psychology and Psychotherapy
Gutenbergstraße 18
Marburg
35032
Germany
Study information
| Study design | Prospective single center randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/04/2008 |
| Completion date | 01/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
35032
Germany
Sponsor information
Swiss National Science Foundation (Switzerland)
Research organisation
Research organisation
Wildhainweg 3
P.O. Box 8232
Bern
CH-3001
Switzerland
| Website | http://www.snf.ch/E/Pages/default.aspx |
|---|---|
"ROR" |
https://ror.org/00yjd3n13 |
Funders
Funder type
Government
Swiss National Science Foundation (PZ00P1-121576/1)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Schweizerischer Nationalfonds, Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerische Nationalfonds, SNF, SNSF, FNS
- Location
- Switzerland
University of Lüneburg, Germany
No information available
University of Marburg, Germany
No information available
Vogelsberg Clinic, Germany
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | 17/04/2008 | Yes | No | ||
| Results article | results | 01/11/2008 | Yes | No | |
| Results article | results | 01/09/2010 | Yes | No |
