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

LaFrance 2014.

Study characteristics
Methods Study design: randomised controlled trial
Study grouping: parallel group
Adequate power (evidence of power calculation): quote: "not being powered for differences between groups," but no data provided.
Allocation concealment method: no information provided
Blinding of outcome assessors: treatment‐blinded trained raters assessed clinician‐scored outcomes
Check of blinding: no information provided
Duration of study: September 2008 to February 2012
Randomisation method: computer‐generated block randomisation
Participants Baseline characteristics
Intervention
  • n: 9

  • Age (mean): 37.9 (SD 11.5) years

  • Sex (% woman): 77.8

  • Marital status currently married (%): 44.4%

  • Educational statusmean: 15.4 (SD 3.9) years


Control
  • n: 7

  • Age (mean): 41.6 (SD 8.3) years

  • Sex (% woman): 100

  • Marital status currently married, n (%): 2 (28.6%)

  • Educational statusmean: 16.0 (SD 3.6) years


Overall
  • n: 16


Inclusion criteria: aged 18–65 years with a VEEG‐confirmed diagnosis of lone PNES and ≥ 1 event in the month prior. Criteria for the diagnosis of events consisted of stereotypic motor manifestations with or without change in level of consciousness.
Exclusion criteria: concurrent mixed epilepsy and PNES or equivocal VEEG findings in discerning between epileptic seizures and PNES; use of monoamine oxidase inhibitor or pimozide within 30 days prior to study entry; current use of sumatriptan succinate or other serotonin‐1 receptor agonist; allergy or sensitivity to sertraline; current enrolment in CBT for PNES; current or past‐year self‐mutilation; frank psychosis; current suicidality with intent to self‐harm; serious illness; active substance or alcohol use or dependence that could interfere with participation; pending litigation and current application for long‐term disability.
Pretreatment: no statistically significant differences at baseline between groups.
Interventions Intervention characteristics
Intervention
  • Description: CBT‐informed psychotherapy treatment, 12 weekly, 1‐hour sessions using workbook.

  • Length of treatment: 12 weeks

  • Longest follow‐up after end of treatment: none

  • Comedications/other treatments while in the study: none


Control
  • Description: TAU. Participants followed up with their treating neurologist and were seen biweekly for assessments

  • Length of treatment: 16 weeks

  • Longest follow‐up after end of treatment: none

  • Comedications/other treatments while in the study: none


The study included two other interventions, Sertraline hydrochloride (25‐200 mg/d), and CBT+ Sertraline hydrochloride (25‐200 mg/d) which were not relevant to this review.
Outcomes Monthly seizure frequency (reduction in %)
  • Outcome type: dichotomous


Seizure freedom
  • Outcome type: dichotomous


Level of functioning (GAF)
  • Outcome type: continuous


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


Mental statedepression (BDI)
  • Outcome type: continuous


Mental stateanxiety (BAI)
  • Outcome type: continuous


Quality of life (QOLIE31)
  • 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: "Participants were randomised 1:1:1:1 into 1 of 4 treatment arms using a computer‐generated blocked randomisation."
Allocation concealment (selection bias) Unclear risk Quote: "blocked schedule."
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "Given the nature of interventions delivery, clinicians in the study were not blinded to the intervention."
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "Treatment‐blinded trained raters assessed clinician‐scored outcomes after reliability was established. Interrater reliability was established by having raters score a sample of the same patients and having the results reviewed."
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No data.
Selective reporting (reporting bias) Low risk Matches study protocol.
Other bias Low risk No other apparent sources of bias.