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. 2020 Jul 17;2020(7):CD005331. doi: 10.1002/14651858.CD005331.pub3

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.
Participants Baseline characteristics
Intervention
  • n: no information


Control
  • n: no information


Overall
  • n: 48

  • Duration of symptoms (mean): 3.9 (SD 4.5) years

  • Age (mean): 36.8 (SD 11.31) years

  • Sex (% woman): 77.3%

  • Marital status currently married (%): 44.4%

  • Educational status: 57.8% (technical or occupational education)


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
Interventions Intervention characteristics
Intervention
  • Description: hypnotic treatment 8 weekly 1‐hour session+ TAU as inpatients + 1 initial treatment session. Also self‐hypnosis practice daily between sessions

  • Length of treatment: 2 months

  • Longest follow‐up after end of treatment: 6 months

  • Comedications/other treatments while in the study: normal treatment for conversion disorder as inpatients (group therapy, physiotherapy and more)


Control
  • Description: 8 weekly 1‐hour session with a therapist, talking about non‐therapy specific issues. Homework was writing reflections on what had been talked about.

  • Length of treatment: 2 months

  • Longest follow‐up after end of treatment: 6 months

  • Comedications/other treatments while in the study: normal treatment for conversion disorder as inpatients (group therapy, physiotherapy and more)

Outcomes Severity of impairment (VRMC)
  • Outcome type: continuous


Mental state (SCL‐90)
  • Outcome type: continuous


Dropout
  • Outcome type: dichotomous

  • Data value: endpoint

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.