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

Not Applicable

Completed

Conditions: Somatoform disorder
Mental and Behavioural Disorders

Registration Number: ISRCTN17188363

Lead Sponsor: Psychological Institute, University of Mainz (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1. Self-reported psychological symptoms, measured using the Brief Symptom Inventory (BSI)<br>2. Depressive symptoms, measured using the Beck Depression Inventory (BDI)<br>3. Functional limitations, measured using the Short Form-36 Health Survey (SF-36)<br>4. General life satisfaction, measured using Questions on Life Satisfaction (FLZ-M)<br><br>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