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Cost-effectiveness of i-Sleep, a guided online CBT intervention, for patients with insomnia in general practice: protocol of a pragmatic randomized controlled trial.

van der Zweerde, Tanja and Lancee, Jaap and Slottje, Pauline and Bosmans, Judith and Van Someren, Eus and Reynolds, Charles and Cuijpers, Pim and van Straten, Annemieke (2016) Cost-effectiveness of i-Sleep, a guided online CBT intervention, for patients with insomnia in general practice: protocol of a pragmatic randomized controlled trial. BMC Psychiatry, 16. 85 - ?.

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BACKGROUND: Insomnia is a highly prevalent disorder causing clinically significant distress and impairment. Furthermore, insomnia is associated with high societal and individual costs. Although cognitive behavioural treatment for insomnia (CBT-I) is the preferred treatment, it is not used often. Offering CBT-I in an online format may increase access. Many studies have shown that online CBT for insomnia is effective. However, these studies have all been performed in general population samples recruited through media. This protocol article presents the design of a study aimed at establishing feasibility, effectiveness and cost-effectiveness of a guided online intervention (i-Sleep) for patients suffering from insomnia that seek help from their general practitioner as compared to care-as-usual. METHODS/DESIGN: In a pragmatic randomized controlled trial, adult patients with insomnia disorder recruited through general practices are randomized to a 5-session guided online treatment, which is called "i-Sleep", or to care-as-usual. Patients in the care-as-usual condition will be offered i-Sleep 6 months after inclusion. An ancillary clinician, known as the psychological well-being practitioner who works in the GP practice (PWP; in Dutch: POH-GGZ), will offer online support after every session. Our aim is to recruit one hundred and sixty patients. Questionnaires, a sleep diary and wrist actigraphy will be administered at baseline, post intervention (at 8 weeks), and at 6 months and 12 months follow-up. Effectiveness will be established using insomnia severity as the main outcome. Cost-effectiveness and cost-utility (using costs per quality adjusted life year (QALY) as outcome) will be conducted from a societal perspective. Secondary measures are: sleep diary, daytime consequences, fatigue, work and social adjustment, anxiety, alcohol use, depression and quality of life. DISCUSSION: The results of this trial will help establish whether online CBT-I is (cost-) effective and feasible in general practice as compared to care-as-usual. If it is, then quality of care might be increased because implementation of i-Sleep makes it easier to adhere to insomnia guidelines. Strengths and limitations are discussed. TRIAL REGISTRATION: Netherlands Trial register NTR 5202 (registered April 17(st) 2015).


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Item Type: Article
Status: Published
CreatorsEmailPitt UsernameORCID
van der Zweerde, Tanja
Lancee, Jaap
Slottje, Pauline
Bosmans, Judith
Van Someren, Eus
Reynolds, Charleschipr@pitt.eduCHIPR
Cuijpers, Pim
van Straten, Annemieke
Date: 16 March 2016
Date Type: Acceptance
Access Restriction: No restriction; Release the ETD for access worldwide immediately.
Journal or Publication Title: BMC Psychiatry
Volume: 16
Page Range: 85 - ?
DOI or Unique Handle: 10.1186/s12888-016-0783-z
Institution: University of Pittsburgh
Schools and Programs: School of Medicine > Psychiatry
Refereed: Yes
Uncontrolled Keywords: CBT-I, Cognitive behavioural therapy, Cost-effectiveness, General practice, Insomnia, Online treatment, Pragmatic randomized controlled trial, Adult, Cognitive Behavioral Therapy, Cost-Benefit Analysis, Family Practice, Female, Humans, Internet, Male, Netherlands, Sleep Initiation and Maintenance Disorders
Funders: European Research Council (671084)
Date Deposited: 21 Jul 2016 19:27
Last Modified: 15 Dec 2018 20:55


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