Gilliam 2019.
Study characteristics | ||
Methods | Multi‐centre, randomised controlled trial conducted in the USA Baseline period: 3 month retrospective baseline (seizures) Treatment period:16 weeks |
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Participants | 140 participants; 77 female 21 to 75 years old 58% focal epilepsy CES‐D score >14 |
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Interventions | Sertraline 50 mg/day to 200 mg/day versus CBT | |
Outcomes | BDI, CES‐D, seizure recurrence and monthly frequency, AEP, adverse events | |
Notes | ITT analysis, 49/72 in sertraline group completed assigned treatment, 49/68 in CBT group completed assigned treatment | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Simple non‐stratified computerised randomisation code generated by an investigator not otherwise involved in the study |
Allocation concealment (selection bias) | Low risk | Treatment assignment obtained by telephone communication (centralised randomisation) |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of participants and personnel not possible by design (sertraline or CBT) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Site investigators blinded to outcome assessment but research assistants implementing study procedures not blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 23/72 participants (32%) in the sertraline group and 19/68 participants (28%) in the CBT group did not complete treatment. Intention‐to‐treat analysis imputed missing data by multiple imputation |
Selective reporting (reporting bias) | Low risk | Outcomes stated in methods section of report are present in the results. No protocol available |
Other bias | High risk | High risk of recall bias as seizure rates were collected retrospectively at baseline |