Baillargeon 2003.
Methods | RCT. | |
Participants | 65 people aged over 50 with chronic (> 6 months) insomnia who had been taking BZDs every night for > 3 months. Recruited through media advertisements or referred by their GP in Canada. 35 participants (21; 60% female) in the intervention condition (mean age = 68.3, SD = 7.4); 30 participants (17; 57% female) in control condition (mean age = 66.4, SD = 6.0). | |
Interventions | Intervention group: CBT plus tapering. CBT involved behavioural, cognitive and educational components. The behavioural component included instructions for stimulus control and procedures for sleep restriction. The cognitive component addressed irrational thinking. The educational component included sleep hygiene education and information on the adverse effects of BZDs. Control group: Tapering supervised by a physician weekly over 8 weeks. |
|
Outcomes | BZD discontinuation, confirmed by blood screening performed at each of 3 measurement points (immediately after treatment completion and at 3‐ and 12‐month follow‐up). | |
Notes | Funding source: Author RV's work was supported by Laval University Chair for Geriatric Research. Grant received from the National Health Research and Development Program, Health Canada (6605‐4573‐702). Declaration of interest: None declared. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Table of random numbers, arranged by a nurse. |
Allocation concealment (selection bias) | Unclear risk | "The treatment assignment could not be concealed from participants, but aggregate outcome data were not revealed to patients or investigators during the study". |
Blinding (performance bias and detection bias) All outcomes | Low risk | While the treatment providers were in regular contact with the patients the method of ascertainment (blood screening) of the objective outcome was not susceptible to bias. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | "At each visit the physician looked for withdrawal symptoms and prescribed either the same or a lower dosage, depending on the patient’s symptoms". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The main outcome measure was benzodiazepine discontinuation, confirmed by blood screening". |
Blinding of outcome assessor (detection bias) subjective outcomes | High risk | No blinding reported. Subjective reports ("benzodiazepine consumption and sleep measures were evaluated by means of the sleep diary completed by participants") could have been influenced. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data. |
Selective reporting (reporting bias) | Low risk | The study protocol is not available but the published report includes the expected outcome which was pre‐specified in the methods section. |