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

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 CONDITION: Somatoform disorder ; Mental and Behavioural Disorders ; Somatoform disorder PRIMARY OUTCOME: 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: 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 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