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
Protocol serial number	1
Sponsor	German Research Foundation (Deutsche Forschungsgemeinschaft)
Funder	German Research Foundation (Deutsche Forschungsgemeinschaft)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Pain intensity and pain disability. Due to the chronic condition, a one year follow-up will service as the primary outcome.
Key secondary outcome measure(s)	Pain intensity and pain disability.
Completion date	30/11/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan