Martin 2007.
| Methods | Study design: randomised controlled trial | |
| Participants |
Diagnosis: multiple somatoform symptoms Method of diagnosis: participants were selected after presentation of ≥ 2 MUPS in the last 6 months, leading to significant clinical distress, according to their GP or to a screening questionnaire. A diagnostic interview (IDCL and Mini‐DIPS) was used to assess study criteria and DSM‐5 psychiatric diagnoses Exclusion criteria: severe current medical condition, chronic medical disease explaining the symptoms, psychotic symptoms, substance dependence Total number randomised: 140 Age: for intervention group, M = 45.7 (SD = 13.6); for control group, M = 51.7 (SD = 15,9) (significant difference at P value < 0.05) Sex: for intervention group 68.6% female (n = 48); for control group, 81.4% female (n = 57) Severity of symptoms at baseline: number of somatoform symptoms, lifetime: for intervention group M = 7.6 (SD = 3.9), for control group M = 6.6 (SD = 3.6); DSM‐IV Somatoform Disorder: for intervention group 91.4% (n = 64), for control group 87.1% (n = 61) Duration of symptoms at baseline:years from onset of somatoform symptoms: for intervention group M = 9.2 (SD = 11.2), for control group M = 11.8 (SD = 12.8) Setting: participants were recruited in primary care practices, general population (news reports), or via 'other ways', treatment took place at an outpatient treatment centre in the university hospital (secondary care) Location: Marburg, Germany Number of treatment centres: 1 Co‐morbidities: affective disorder: for intervention group 66.7% (n = 46); for control group 52.2% (n = 36) DSM‐IV anxiety disorder: for intervention group 41.4% (n = 29); for control group 32.9% (n = 22) Adjunctive therapy: none reported Adjunctive medication: none reported |
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| Interventions | Participants were randomly assigned to either 1. CBT (n = 70) Duration: 1 session of 3‐4 hours, 2 weeks after baseline Treatment protocol: treatment consisted of 1 session in groups of 2‐4 participants. Treatment followed a structured manual with 5 central modules: psychophysiological explanation of symptoms, relaxation, importance of cognition, activity instead of avoidance behaviour, and treatment options and healthcare utilisation (Martin 2007, page 296 for details). Therapist: clinical psychologist or medical specialist for psychotherapeutic medicine, both licences CBT specialists 2. Standard medical care (n = 70) Duration: NA Treatment protocol: NA Therapist: NA |
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| Outcomes |
Time points for assessment: baseline, 4 weeks, and 6 months after baseline Primary outcome: 1. healthcare utilisation (structured interview, not at 4 weeks) 2. number and severity of somatoform symptoms (BSI and SOMS‐7) Secondary outcome: 1. health anxiety (WI) 2. general psychopathological symptoms (GSI) 3. Depressive symptoms (BDI) 4. health‐related internal control (KKG) |
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| Notes |
Date of study: trial conducted between August 2001 ‐ December 2002 Funding source: German Ministry of Research, Education and Science Declarations of interest among the primary researchers: none reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was based on a predefined list of binary variables, using blocking procedures to ensure comparable sample sizes (page 295) |
| Allocation concealment (selection bias) | Low risk | Study assistants enrolled and assigned participants to the groups according to the randomisation list |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel could not be 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 | Low risk | Loss to follow‐up at 6 months 15.7% in both groups (< 20%) |
| Selective reporting (reporting bias) | Low risk | All intended outcomes are reported |
| Treatment fidelity | Low risk | The treatment followed a structured manual with 5 central modules (in German), available on request (Martin 2007, page 296) |
| Researcher allegiance | Low risk | No indication that researchers had a preference for 1 of the treatment modalities |
| Other bias | Low risk | No other sources of bias |