Schweickhardt 2007.

Methods	Study design: randomised controlled trial
Participants	Diagnosis: somatisation Method of diagnosis: participants (18‐65 years old) were included if they screened positive for the SOMS‐2 and the GHQ‐12 and if the attending hospital physician was not able to provide a clear physical explanation for the complaints. The screening criteria for SOMS were 4 somatoform symptoms for men and 6 for women, and the cut‐off for the GHQ was ≥ 2. Other inclusion criteria were: persistent symptoms for at least 3 months, ≥ 5 annual doctor's visits or 2 hospitalisations during the past year as a result of the respective symptoms and availability for ≥ 6 months Exclusion criteria: severe mental disorders, e.g. major depression with suicidal ideation, eating disorders, alcohol or substance abuse, an organic disease deemed responsible for most of the symptoms, psychotherapy ‐ ongoing or completed during the past 3 years, pregnancy and low intellectual capacity Total number randomised: 91 Age: for intervention group, M = 44.43 (SD = 13.329); for control group, M = 49.22 (SD = 11.084) Sex: for intervention group 69.4% women (n = 34), for control group 71.4% women (n = 30) Severity of symptoms at baseline: 55 of the participants (92%) had a somatoform disorder Duration of symptoms at baseline: unknown Setting: general hospital (inpatients). Data were collected in the Departments of Neurology, Internal Medicine, General Medicine and Orthopedics of the University Hospital. A research assistant visited the participating units 3 times per week and systematically examined all new participants Location: Freiburg, Germany Number of treatment centres: 1 (although 4 different departments) Co‐morbidities: diagnostic interviews were conducted with 60 participants (66%). 24 (40%) were had depression and 18 (32%) had an anxiety disorder Adjunctive therapy: none reported Adjunctive medication: none reported
Interventions	Participants were randomly assigned to either 1. Short‐term psychotherapeutic intervention (n = 49) Duration: 5 sessions of approximately 50 minutes, during a period of 2 weeks Treatment protocol: treatment consisted of a program predominantly based on the reattribution model, the World Health Organization training package for primary care physicians, cognitive behavioural techniques and a psychodynamic approach (see Schweickhardt 2007, table 1 for the session topics and ref 29 for the treatment manual) Therapist: licensed psychotherapists (3 physicians and 2 psychologists), who have been working with somatising participants for several years 2. Psychoeducational reading material (n = 42) Duration: NA Treatment protocol: psychoeducational reading material consisting of 9 pages describing the aetiology, course, and treatment recommendation of somatoform symptoms Therapist/face‐to‐face contact: NA
Outcomes	Time points for assessment: baseline, 2 weeks, 3 months and 6 months after baseline Primary outcome: 1. Changes regarding motivation for psychotherapy (FPTM) 2. Contact with a psychotherapist Secondary outcome: 1. number and intensity of somatoform symptoms (SOMS‐7) 2. changes regarding emotional distress (HADS, GHQ) 3. quality of life (SF‐12)
Notes	Date of study: participants were recruited between June 2002 and May 2004. The last follow‐up assessments were performed in November 2004 Funding source: this clinical trial was supported by grants from the German Research Association (Deutsche Forschungsgemeinschaft) Declarations of interest among the primary researchers: none reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Envelopes containing the allocation information were created in a random order. Participants who had fulfilled all inclusion criteria were assigned to the 2 different groups
Allocation concealment (selection bias)	Low risk	Randomisation was performed by an independent statistician. He was not aware of the therapy allocation or the details of the study design
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants were not blinded due to the study conditions. Data were collected by independent research assistants, it is unknown if they were blinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	Participants were not blinded, and most outcomes were participant reported
Incomplete outcome data (attrition bias) All outcomes	High risk	Missing data at 6‐month follow‐up for psychotherapy motivation and the secondary outcomes were up to 28.5% in the intervention group and 23.8% in the control group (> 20%)
Selective reporting (reporting bias)	Low risk	All intended outcomes reported
Treatment fidelity	Low risk	Treatment was based on a manual regarding therapy goals, basic concepts and operationalisation of the individual therapy steps (Schweickhardt 2007, ref 29)
Researcher allegiance	Low risk	No indication that researchers had a preference for 1 of the treatment modalities
Other bias	Unclear risk	A high percentage (29%) of the participants from the control group became involved in psychotherapy. This might have influenced the results