Contact information
Type
Scientific
Primary contact
Dr Ulrich T Egle
ORCID ID
Contact details
Untere zahlbacher 8
Mainz
D-55131
Germany
+49 (0)6131 177381
egle@psychosomatik.klinik.uni-mainz.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Acronym
MASOPA
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/01/2000
Overall trial end date
30/11/2005
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
150
Participant exclusion criteria
Age <18 or >65, psychosis, severe substance dependency, missing understanding of German language, and a request to retire because of disease.
Recruitment start date
01/01/2000
Recruitment end date
30/11/2005
Locations
Countries of recruitment
Germany
Trial participating centre
Untere zahlbacher 8
Mainz
D-55131
Germany
Sponsor information
Organisation
German Research Foundation (Deutsche Forschungsgemeinschaft)
Sponsor details
Kennedyallee 40
Bonn
D53175
Germany
+49 (0)228 8851
postmaster@dfg.de
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
German Research Foundation (Deutsche Forschungsgemeinschaft)
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