Condition category
Mental and Behavioural Disorders
Date applied
03/02/2005
Date assigned
04/04/2005
Last edited
04/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes