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

Goldstein 2010.

Study characteristics
Methods Study design: randomised controlled trial
Study grouping: parallel group
Adequate power (evidence of power calculation): sample size calculation. Based on previous experience, we assumed a true mean change in monthly seizure frequency of 7.3 in the CBT group, no change in the SMC group, and a common SD of 9.5 seizures. Therefore, 28 per group were required to detect a difference with this effect size (Cohen 0.768) with 80% power at P < 0.05. Allowing for a 20% dropout rate, the study authors sought to recruit 35 participants per group; resource limitations resulted in recruitment of 33 per group.
Allocation concealment method: developed from a table of random numbers, using unstratified permuted blocks of 4, and concealed in sealed envelopes. The envelopes were then numbered consecutively and given to an independent clinician who allocated them in order as patients gave written informed consent.
Blinding of outcome assessors: no information provided
Check of blinding: no information provided
Duration of study: June 2001 to April 2007
Randomisation method: independently prepared sequence of consecutive, randomised treatment assignments.
Participants Baseline characteristics
Intervention
  • n: 33

  • Duration of symptoms: 6.3 years (mean 5.9)

  • Age (mean): 37.4 (SD 12.6) years

  • Sex (% woman): 72.73%

  • Ethnicity: 31 white

  • Marital status currently married, n (%): 16 (48.5%)

  • Educational status: 13 unemployed


Control
  • Number of participants: 31

  • Duration of symptoms: 5.1 years (mean 6.8)

  • Age (mean): 35.9 (SD 15.1) years

  • Sex (% woman): 83.87%

  • Ethnicity: 27 white

  • Marital status currently married, n (%): 16 (51.6%)

  • Educational status: 18 unemployed


Overall
  • n: 64


Inclusion criteria: aged 18–70 years; clinical diagnosis of PNES primarily confirmed by VEEG telemetry, and only if this was not feasible by ictal EEG, or where the referrer and consultant neuropsychiatrists involved in the study agreed that there was no doubt about the diagnosis and that further investigation was unjustified ('clinical consensus').
Exclusion criteria: coexistent diagnosis (past occurrence) of epilepsy; 2 seizures per month; current drug or alcohol misuse; benzodiazepine use exceeding the equivalent of diazepam 10 mg/day; IQ 70
Pretreatment: similar demographic characteristics and seizure histories at enrolment.
Interventions Intervention characteristics
Intervention
  • Description: CBT. Up to 12 weekly/every 2 weeks for 1‐hour outpatient sessions of CBT with a CBT‐trained nurse therapist with experience in working with people with PNES.

  • Length of treatment: 4 months

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

  • Comedications/other treatments while in the study: SMC as received by control


Control
  • Description: SMC. Participants were offered ongoing clinic review by a neuropsychiatrist. Appointment frequency was determined by clinical need. Sessions were supportive in nature and provided explanations about the psychological basis of the seizures and supervised withdrawal of AEDs.

  • Length of treatment: 4 months

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

  • Comedications/other treatments while in the study: none

Outcomes Monthly seizure frequency
  • Outcome type: continuous


Mental stateanxiety (HADS)
  • Outcome type: continuous


Mental statedepression (HADS)
  • Outcome type: continuous


Level of functioning (WSAS)
  • Outcome type: continuous


Primary health service use (number of GP consultations)
  • Outcome type: continuous


Dropout
  • Outcome type: dichotomous

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "patients were randomised to CBT or SMC using an independently prepared sequence of consecutive, randomised treatment assignments. This was developed from a table of random numbers, using unstratified permuted blocks of 4, and concealed in sealed envelopes."
Allocation concealment (selection bias) Low risk Quote: "This was developed from a table of random numbers, using unstratified permuted blocks of 4, and concealed in sealed envelopes. The envelopes were then numbered consecutively and given to an independent clinician who allocated them in order as patients gave written informed consent."
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "Therapy sessions were audio‐recorded. Two independent raters evaluated the content of sessions 4 and 9. Overall ratings of therapeutic alliance and CBT were calculated."
Comment: no blinding due to the nature of the study, but independent rating of therapy to assure consistency.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No information provided.
Incomplete outcome data (attrition bias)
All outcomes Low risk Dropouts accounted for.
Selective reporting (reporting bias) Low risk Clinical trials register NCT00688727. The study followed this.
Other bias Low risk No other apparent sources of bias.