Rios Romenet 2013.

Methods	Randomised, 3‐arm, controlled pilot study
Participants	Insomnia diagnosis criteria (method of diagnosis): minimal SCOPA‐sleep nocturnal subscore ≥ 7. Insomnia present ≥ 6 months Other diagnoses: idiopathic PD Disease duration (mean ± SD): 5.0 ± 3.3 years Number of participants randomised: n = 18 Doxepin: n = 6 CBT: n = 6 Placebo: n = 6 Age, mean (SD) years: 66.4 (12.4) Gender (M/F): 14/4 Race/ethnicity: all participants spoke English or French Country: Quebec, Canada Setting: recruited from movement disorders clinics of the McGill University health centre Included: idiopathic PD and insomnia Excluded: frequent (more than twice weekly) use of sedative medications at night (including sedative antidepressants), untreated restless legs syndrome, night shift work or other occupational causes of abnormal sleep pattern, insomnia related to suboptimal dopaminergic therapy, other reversible causes of insomnia detected on baseline interview, premenopausal women not using effective methods of contraception, dementia (defined according to PD dementia criteria), change in dopaminergic therapy over the preceding 3 months, Hoehn and Yahr > 4 (i.e. non‐ambulatory), use of non‐selective MAOI or rasagiline (due to potential doxepin contraindication), hypersensitivity to doxepin, untreated narrow angle glaucoma or severe urinary retention Withdrawals: n = 2 CBT: n = 1 (unable to follow instructions and could not complete evaluations) Placebo: n = 1 (health problems) Baseline imbalances: no significant differences between groups at baseline in age, sex, disease duration, levodopa use, disease severity, or primary or secondary sleep outcomes (table 1). Participants in the CBT group had lower baseline MoCA scores (cognitive functioning)
Interventions	Intervention 1: doxepin 10 mg at bedtime Intervention 2: CBT, included 3 key interventions sleep hygiene training, CBT and bright light therapy. CBT and sleep hygiene instituted by the Department of Psychiatry of the Jewish General Hospital, Montreal. Group setting ‐ 6 × 90 min weekly sessions with 2 participants per group. Light therapy daily for 30 min (morning or night depending on nature of sleep problem) Comparator: "placebo" ‐ "inactive" ‐ consisted of 30‐min light therapy using red light below the threshold required to entrain light cycles No placebo capsules were given Participants were informed that some forms of light therapy were expected to be less active, but were not told what type of condition was inactive
Outcomes	Primary insomnia outcomes ISI SCOPA ‐ night scale Adverse events Secondary outcomes: Daytime fatigue scores (FSS) Cognitive function (MoCA)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: 'Block randomisation" (block size = 9) Because CBT is group therapy randomisation of 1 participant to CBT led to automatic assignment of subsequent 2 participants to the non‐pharmacological arm (Pg 671).
Allocation concealment (selection bias)	High risk	No placebo tablets were given (Pg 671).
Blinding of participants and personnel (performance bias) All outcomes	High risk	Placebo was not disclosed as an inactive placebo, but treatment assignment was otherwise non‐blinded (Pg 671).
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information on who undertook the outcome assessments
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear ITT
Selective reporting (reporting bias)	Unclear risk	No details given
Other bias	Low risk	Full disclosure, no conflict of interest