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

Abstract

BackgroundInsomnia 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/designIn 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.DiscussionThe 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 registrationNetherlands Trial register NTR 5202 (registered April 17st 2015).

Nurse-Guided Internet-Delivered Cognitive Behavioral Therapy for Insomnia in General Practice: Results from a Pragmatic Randomized Clinical Trial

“…2015/258), and it was registered with the Dutch Trial Registry (NTR5202, April 17, 2015). The detailed protocol is available elsewhere [22].…”

“…We made two changes to our original protocol [22] both with the intention to enhance recruitment. In the original protocol the recruitment strategy was described as GPs inviting patients during a face-to-face consultation for sleep problems.…”

Psychological Considerations and Interventions in Inflammatory Bowel Disease Patient Care

“…The existing literature is promising, suggesting improved outcomes in IBD with use of these interventions 77, 78 . Web-based psychological interventions are effective in treating depression and anxiety 79–81 , insomnia 82 , and irritable bowel syndrome 83, 84 . These strategies may bridge the treatment gap that currently exists for integrated behavioral medicine practice in gastroenterology.…”

Effectiveness of sleep self-management group intervention in Chinese patients with insomnia disorder

“…Insomnia is a highly prevalent health problem worldwide that can induce substantial consequence and with high social economic cost . The term insomnia can be variously used to describe a symptom or a disorder of sleep disturbance.…”

“…Insomnia is a highly prevalent health problem worldwide that can induce substantial consequence and with high social economic cost. 1 The term insomnia can be variously used to describe a symptom or a disorder of sleep disturbance. According to Diagnostic and Statistical Manual of Mental Disorders (DSM-5), insomnia disorder is characterized by difficulty in initiating and/or maintaining sleep for at least three nights per week in at least 3 months.…”