I-sleep: online CBT for insomnia (WC2014-058)

Methods

Starting date: 01/01/2015

Study design: The proposed study entails a randomized controlled intervention study, conducted in the general practice. Random allocation will take place at the individual level on a 1:1 ratio. Participants are randomised using random sequence block randomisation (blocks of 2, 4 or 6), stratified by whether or not they have used medication in the past 4 weeks at least once and by individual psychological wellbeing practitioner (PWP). Patients will receive the outcome of randomization by email. GPs will be notified by phone. Due to the nature and design of the study, blinding of the researchers, PWPs or patients is not possible.

Study population: The study population will consist of consenting adults (N=160) referring to their GP for treatment of insomnia (diagnosis according to DSM-5). Patients suffering from sleep apnea, that are pregnant or breastfeeding, work in night shifts, or suffer from psychosis and/or suicidality will be excluded. Patients suffering from other sleep disorders will not be excluded, but their diagnosis will be recorded.

Intervention: The I-Sleep intervention is a 6 week online CBT program consisting of psycho-education, sleep hygiene, sleep restriction, stimulus control, cognitive restructuring and relapse prevention. A psychological wellbeing practitioner (PWP, Dutch: POH-GGZ) will offer guidance and feedback to increase motivation and adherence.

Main study parameters: The primary outcome of the study will be insomnia severity as measured by the Insomnia Severity Index. The TIC-P questionnaire will be used to assess costs. Questionnaires will be administered at baseline, end of treatment and follow-up (6 months and 12 months).