Evaluation of a randomised-controlled cognitive-behavioural individual therapy for patients with somatoform disorders
| ISRCTN | ISRCTN17188363 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17188363 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Department of Clinical Psychology and Psychotherapy
Psychological Institute University of Mainz
Staudingerweg 9
Mainz
55099
Germany
| Phone | +49 (0)6131 39 24621 |
|---|---|
| hiller@uni-mainz.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/01/2007 |
| Completion date | 30/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 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
55099
Germany
Sponsor information
Psychological Institute, University of Mainz (Germany)
University/education
University/education
Outpatient Department of Psychotherapy
Psychological Institute University of Mainz
Staudingerweg 9
Mainz
55099
Germany
"ROR" |
https://ror.org/023b0x485 |
|---|
Funders
Funder type
University/education
Johannes Gutenberg-Universität Mainz
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- Johannes Gutenberg University of Mainz, University of Mainz, Johannes Gutenberg University Mainz, JGU
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
30/05/2017: Publication reference added.
