Moene 2002.
Study characteristics | ||
Methods |
Study design: randomised controlled trial Study grouping: parallel group Adequate power (evidence of power calculation): Quote: "A power of 80% and an alpha (two‐sided) of 5% showed that 25 patients would have been sufficient for each group in order to detect differences between groups with an effect size of d=0.8" Allocation concealment method: none described Blinding of outcome assessors: assessors were blinded Check of blinding: no information provided Duration of study: 1991–1996 Randomisation method: block randomisation using blocks with the following sized: 3 × 4, 2 × 6, 2 × 8, 2 × 4 and 2 × 2. |
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Participants |
Baseline characteristics Intervention
Control
Overall
Inclusion criteria: positive diagnosis of somatisation disorder with conversion symptoms of the motor type according to DSM‐III‐R criteria; duration of ≥ 1 month; aged 18–65 years; no problem speaking the Dutch language. Patients had to be available for full course of treatment and assessment sessions, and agree to received no other treatment during project and not to change their medication except when indicated and temporarily (e.g. temazepam 1 mg to sleep or oxazepam 20 mg during the day). Exclusion criteria: evidence of a neurological disorder explaining the conversion symptom; major affective disorder of the melancholy type or other severe psychiatric diagnosis requiring immediate treatment. Pretreatment: no statistically significant differences at baseline between groups. Diagnosis consistent with conversion disorder as specified in ICD‐10 or DSM‐IV |
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Interventions |
Intervention characteristics Intervention
Control
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Outcomes |
Severity of impairment (VRMC)
Mental state (SCL‐90)
Dropout
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method used for randomisation was not provided. |
Allocation concealment (selection bias) | Low risk | Allocation was concealed from the therapist and assessor. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not possible, due to the interventions believer. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Allocation was concealed from the therapist and assessor. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear dropout reporting in terms of total number of participants in each group at each stage. |
Selective reporting (reporting bias) | High risk | Baseline demographic factors not stratified between groups. |
Other bias | Low risk | No other apparent sources of bias. |