A randomised comparison of out patient psychodynamic versus cognitive behavioural group psychotherapy in patients with somatoform pain
| ISRCTN | ISRCTN57684245 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57684245 |
| Secondary identifying numbers | 1 |
- Submission date
- 03/02/2005
- Registration date
- 04/04/2005
- Last edited
- 04/10/2007
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ulrich T Egle
Scientific
Scientific
Untere zahlbacher 8
Mainz
D-55131
Germany
| Phone | +49 (0)6131 177381 |
|---|---|
| egle@psychosomatik.klinik.uni-mainz.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | MASOPA |
| Study objectives | Somatoform disorder with pain as a leading complaint (International Statistical Classification of Diseases and Related Health Problems - tenth revision [ICD10]: F45). The study was designed to compare efficacy of psychodynamic and cognitive behavioural group psychotherapy in patients with somatoform pain. Therefore, a total of 150 patients are randomised to one of either therapies. Both therapies are manualized and supervisioned by video. Patients living more than one hour driving distance to the university hospital who cannot take part in out patient therapy serve as controls by receiving care as usual. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Somatoform pain |
| Intervention | Patients receive out patient psychotherapy for 6 months. They were randomised into psychodynamic versus cognitive behavioural therapy. Therapy was manualized. Sessions took place twice a week and once a week respectively. The total amount of therapy was 3600 minutes in psychodynamic and 2750-3000 minutes cognitive behavioural therapy. Groups consist of 8-10 patients starting therapy together, they were closed for further participants. |
| Intervention type | Other |
| Primary outcome measure | Pain intensity and pain disability. Due to the chronic condition, a one year follow-up will service as the primary outcome. |
| Secondary outcome measures | Pain intensity and pain disability. |
| Overall study start date | 01/01/2000 |
| Completion date | 30/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 150 |
| Key inclusion criteria | Patients were included if they had persistent pain (>6 months) without an adequate physical explanation after a broad multidisciplinary check and if they could understand German. Patients were referred by their general practitioners or specialists in or outside the university hospital. A total of 150 patients will be randomised to one of either therapies, patients living more than one hour driving distance to the university hospital cannot take part in out patient therapy and will serve as controls by receiving treatment as usual (n = 70). Due to the chronic condition, a one year follow-up will serve as primary outcome. A two year follow-up is intended. |
| Key exclusion criteria | Age <18 or >65, psychosis, severe substance dependency, missing understanding of German language, and a request to retire because of disease. |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 30/11/2005 |
Locations
Countries of recruitment
- Germany
Study participating centre
Untere zahlbacher 8
Mainz
D-55131
Germany
D-55131
Germany
Sponsor information
German Research Foundation (Deutsche Forschungsgemeinschaft)
Research organisation
Research organisation
Kennedyallee 40
Bonn
D53175
Germany
| Phone | +49 (0)228 8851 |
|---|---|
| postmaster@dfg.de | |
"ROR" |
https://ror.org/018mejw64 |
Funders
Funder type
Research organisation
German Research Foundation (Deutsche Forschungsgemeinschaft)
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 |
