Evaluation of a randomised-controlled cognitive-behavioural individual therapy for patients with somatoform disorders

ISRCTN	ISRCTN17188363
DOI	https://doi.org/10.1186/ISRCTN17188363
Protocol serial number	N/A
Sponsor	Psychological Institute, University of Mainz (Germany)
Funder	Johannes Gutenberg-Universität Mainz

Submission date: 29/03/2007
Registration date: 02/05/2007
Last edited: 30/05/2017

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

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Wolfgang Hiller
Scientific

Department of Clinical Psychology and Psychotherapy
Psychological Institute University of Mainz
Staudingerweg 9
Mainz
55099
Germany

Phone	+49 (0)6131 39 24621
Email	hiller@uni-mainz.de

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Evaluation of a randomised-controlled cognitive-behavioural individual therapy for patients with somatoform disorders
Study acronym	SOMA
Study objectives	To determine whether a new Cognitive-Behavioural Therapy (CBT) multicomponent manual for individual therapy for somatoform disorders is effective.
Ethics approval(s)	Ethics Commission of the German Society of Psychology, 29/10/2006, ref: WH 28092006DGPS
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Severity and distress related to the somatoform symptoms as indicated on Somatoform Disorders Screening Instrument - 7 days (SOMS-7) measured at first contact with the patient (after referral), beginning of therapy (after session no. 1), end of therapy (after session no. 20), 6-month follow-up and 12-month follow-up
Key secondary outcome measure(s)	1. Self-reported psychological symptoms, measured using the Brief Symptom Inventory (BSI) 2. Depressive symptoms, measured using the Beck Depression Inventory (BDI) 3. Functional limitations, measured using the Short Form-36 Health Survey (SF-36) 4. General life satisfaction, measured using "Questions on Life Satisfaction" (FLZ-M) Measured at first contact with the patient (after referral), beginning of therapy (after session no. 1), end of therapy (after session no. 20), 6-month follow-up and 12-month follow-up
Completion date	30/03/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	60
Key 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 5. Written informed consent
Key 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
Date of first enrolment	01/01/2007
Date of final enrolment	30/03/2008

Locations

Countries of recruitment

Germany

Study participating centre

Psychological Institute University of Mainz

Mainz
55099
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	25/05/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

30/05/2017: Publication reference added.