Condition category
Mental and Behavioural Disorders
Date applied
29/03/2007
Date assigned
02/05/2007
Last edited
10/05/2007
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

Prof Wolfgang Hiller

ORCID ID

Contact details

Department of Clinical Psychology and Psychotherapy
Psychological Institute University of Mainz
Staudingerweg 9
Mainz
55099
Germany
+49 (0)6131 39 24621
hiller@uni-mainz.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

SOMA

Study hypothesis

To determine whether a new Cognitive-Behavioural Therapy (CBT) multicomponent manual for individual therapy for somatoform disorders is effective.

Ethics approval

Ethics Commission of the German Society of Psychology, approved on 29 October 2006, Ref: WH 28092006DGPS

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 disorder

Intervention

All outpatients receive cognitive behavioural therapy for 5 months. The patients are referred by their general practitioners. After randomised assignment, the intervention group receives 20 sessions (50 minutes per session) of cognitive behavioural individual psychotherapy. The subjects randomised into the waiting list control group must wait for 5 months before starting with the same intervention. The treatment consists of modules and focuses on explanatory illness model, stressors and coping with stress, the effect of attention versus distraction on bodily complaints or dysfunctions, relaxation training, cognition and beliefs about unexplained bodily symptoms and illness behaviour.

The primary and secondary outcomes will be measured at:
1. First contact with the patient (after referral)
2. Beginning of therapy (after session no. 1)
3. End of therapy (after session no. 20)
4. 6-month follow-up
5. 12-month follow-up

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Severity and distress related to the somatoform symptoms as indicated on Somatoform Disorders Screening Instrument - 7 days (SOMS-7)

Secondary outcome measures

1. Self-reported psychological symptoms (Brief Symptom Inventory [BSI])
2. Depressive symptoms (Beck Depression Inventory [BDI])
3. Functional limitations (Short Form-36 Health Survey [SF-36])
4. General life satisfaction ("Questions on Life Satisfaction" [FLZ-M])

Overall trial start date

01/01/2007

Overall trial end date

30/03/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. The presence of a somatoform disorder (Somatic Symptom Inventory [SSI] 3 - patients with at least three current Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition [DSM IV] somatoform symptoms)
2. The somatoform disorder is the main treatment issue (co-morbidities are allowed)
3. Indication for individual therapy
4. Age: 18-65 years old
5. Written informed consent

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

1. Age: under 18, over 65 years
2. Ongoing psychological treatment
3. Treatment in a psychiatric hospital during the last 5 years
4. Acute psychotic or manic symptoms
5. Substance dependency
6. Severe depression, suicidal thoughts or behaviours
7. Post Traumatic Stress Disorder (PTSD) and personality disorder (clusters A & B)
8. Dementia or neurodegenerative disorders
9. Unable to understand German language
10. Request of early retirement because of somatoform disorder

Recruitment start date

01/01/2007

Recruitment end date

30/03/2008

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Clinical Psychology and Psychotherapy
Mainz
55099
Germany

Sponsor information

Organisation

Psychological Institute, University of Mainz (Germany)

Sponsor details

Outpatient Department of Psychotherapy
Psychological Institute University of Mainz
Staudingerweg 9
Mainz
55099
Germany

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Outpatient Department of Psychotherapy of the Psychological Institute, University of Mainz (Germany)

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