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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17188363

Enrollment

Registered

2007-05-02

Start date

2007-01-01

Completion date

Unknown

Last updated

2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Somatoform disorder Mental and Behavioural Disorders Somatoform disorder

Interventions

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 (

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026