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BMC Psychiatry
Published in: BMC Psychiatry 1/2016

Open Access 01-12-2016 | Study protocol

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

Authors: Tanja van der Zweerde, Jaap Lancee, Pauline Slottje, Judith Bosmans, Eus Van Someren, Charles Reynolds III, Pim Cuijpers, Annemieke van Straten

Published in: BMC Psychiatry | Issue 1/2016

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Abstract

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 17st 2015).
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Metadata
Title
Cost-effectiveness of i-Sleep, a guided online CBT intervention, for patients with insomnia in general practice: protocol of a pragmatic randomized controlled trial
Authors
Tanja van der Zweerde
Jaap Lancee
Pauline Slottje
Judith Bosmans
Eus Van Someren
Charles Reynolds III
Pim Cuijpers
Annemieke van Straten
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2016
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/s12888-016-0783-z

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