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

Untere zahlbacher 8
Mainz
D-55131
Germany

Phone +49 (0)6131 177381
Email egle@psychosomatik.klinik.uni-mainz.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymMASOPA
Study objectivesSomatoform 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) studiedSomatoform pain
InterventionPatients 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 typeOther
Primary outcome measurePain intensity and pain disability. Due to the chronic condition, a one year follow-up will service as the primary outcome.
Secondary outcome measuresPain intensity and pain disability.
Overall study start date01/01/2000
Completion date30/11/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants150
Key inclusion criteriaPatients 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 criteriaAge <18 or >65, psychosis, severe substance dependency, missing understanding of German language, and a request to retire because of disease.
Date of first enrolment01/01/2000
Date of final enrolment30/11/2005

Locations

Countries of recruitment

  • Germany

Study participating centre

Untere zahlbacher 8
Mainz
D-55131
Germany

Sponsor information

German Research Foundation (Deutsche Forschungsgemeinschaft)
Research organisation

Kennedyallee 40
Bonn
D53175
Germany

Phone +49 (0)228 8851
Email postmaster@dfg.de
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan