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

Dallocchio 2016.

Study characteristics
Methods Study design: randomised controlled trial
Study grouping: parallel group
Adequate power (evidence of power calculation): none mentioned
Allocation concealment method: none mentioned
Blinding of outcome assessors: a single rater blinded to the aims of the study and the time evaluation (PMDRS)
Check of blinding: none
Duration of study: no information
Randomisation method: block randomisation (size = 4 with balance combinations)
Participants Baseline characteristics
Intervention
  • n: 10

  • Duration of symptoms: 20.7 (SD 10.5) months

  • Age (mean): 33.7 (SD 7.9) years

  • Sex (% woman): 60%


Control
  • n: 11

  • Duration of symptoms: 17.1 (SD 12.9) months

  • Age (mean): 34.7 (SD 10.1) years

  • Sex (% woman): 82%


Overall
  • n: 21


Inclusion criteria: people with functional movement disorder (conversion disorder, in accordance to DSM‐IV)
Exclusion criteria: none mentioned
Pretreatment: not assessed. No statistically significant differences apparent at baseline between groups.
Interventions Intervention characteristics
Intervention
  • Description: CBT + APA (60‐minute sessions twice a week for 12 weeks)

  • Length of treatment: 12 weeks

  • Longest follow‐up after end of treatment: none

  • Comedications/other treatments while in the study: none


Control
  • Description: CBT alone (90‐minute session once a week for 12 weeks)

  • Length of treatment: 12 weeks

  • Longest follow‐up after end of treatment: none

  • Comedications/other treatments while in the study: none

Outcomes Overall physical impact (PMDRS total score) (SD)
  • Outcome type: continuous


Mental stateanxiety (BAI)
  • Outcome type: continuous


Mental statedepression (HDSR)
  • Outcome type: continuous


Dropout
  • Outcome type: dichotomous

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Block procedure (block size = 4 with balanced combinations).
Allocation concealment (selection bias) Unclear risk No information provided.
Blinding of participants and personnel (performance bias)
All outcomes High risk Mentioned as single‐blind, but only the rater was blinded.
Blinding of outcome assessment (detection bias)
All outcomes Low risk A single rater blinded to the aims of the study and time valuation completed the PMDRS in a randomised order.
Incomplete outcome data (attrition bias)
All outcomes Low risk Dropouts were accounted for.
Selective reporting (reporting bias) Unclear risk No protocol available.
Other bias Low risk No apparent sources of bias.