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

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

Research output: Contribution to journalArticleAcademicpeer-review

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 17(st) 2015).

Original languageEnglish
Pages (from-to)85
JournalBMC Psychiatry
Volume16
DOIs
Publication statusPublished - 2 Apr 2016

Cite this

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

In: BMC Psychiatry, Vol. 16, 02.04.2016, p. 85.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Cost-effectiveness of i-Sleep, a guided online CBT intervention, for patients with insomnia in general practice

T2 - protocol of a pragmatic randomized controlled trial

AU - van der Zweerde, Tanja

AU - Lancee, Jaap

AU - Slottje, Pauline

AU - Bosmans, Judith

AU - Van Someren, Eus

AU - Reynolds, Charles

AU - Cuijpers, Pim

AU - van Straten, Annemieke

PY - 2016/4/2

Y1 - 2016/4/2

N2 - 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).

AB - 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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KW - Cognitive Therapy

KW - Cost-Benefit Analysis

KW - Family Practice

KW - Female

KW - Humans

KW - Internet

KW - Male

KW - Netherlands

KW - Sleep Initiation and Maintenance Disorders

KW - Journal Article

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

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JO - BMC Psychiatry

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SN - 1471-244X

ER -