App-delivered Cognitive-behavioral Therapy for Insomnia Among Patients With Musculoskeletal Complaints
NCT ID: NCT05572697
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
105 participants
INTERVENTIONAL
2022-10-07
2025-11-30
Brief Summary
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Detailed Description
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Based on sample size calculation recruiting 15 clusters with 2:1 randomization will achieve 80 % power to detect a 4-point difference between the intervention and usual treatment group on the insomnia severity index (ISI).
Edit 25.08.23: We noted in the review process of a protocol paper that the description of our sample size calculation implied that 150 participants would be included in the study, rather than that 150 potential participants would be screened and that we anticipated that 5 from each group of the 15 clusters would be eligible (i.e. 75 included in the study). We have also revisited the sample size calculations to account for dropouts and low adherence rates known to be a problem in digital interventions. We expect a dropout rate of approximately 20 % and that around 50 % of the participants in the intervention group will complete at least four of the dCBT-I modules. Given that the per-protocol analysis is of particular interest in this study, we aim to recruit 21 clusters to account for the fact that we expect an average of four participants per cluster in the control group to complete the follow-up, and an average of two participants in the intervention group to complete at least four of the modules and attend the follow-up. As total sample size is hard to predict and the sample size is based on number of clusters we have not changed the total enrollment number.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Digital Cognitive-behavioral therapy for insomnia (dCBT-I)
In addition to the standard rehabilitation program, participants will receive the sleep intervention delivered via a smartphone app. We will use a Norwegian a program named Assistert Selvhjelp (In English: "Assisted Self-Help"). The app is fully automated and requires no contact with healthcare personnel. It can also be assessed on computers, but in the present project we will use the app-delivered version. It is based on the principles from face-to-face CBT-I including several modules consisting of sleep hygiene, stimulus control sleep restriction, cognitive therapy, and relaxation training. The modules also consist of learning material (e.g., quizzes and materials explaining and educating the patients about important sleep dimensions).
Digital Cognitive-behavioral therapy for insomnia (dCBT-I)
6 week sleep intervention delivered via a smartphone app while taking part in inpatient multimodal rehabilitation for chronic pain lasting 2+2 weeks.
Usual care
Participants randomized to usual care will receive the standard inpatient rehabilitation program. This is a traditional rehabilitation program consisting of physical activity, mindfulness excises, psychoeducation and acceptance and commitment therapy. One of the educational sessions is about sleep. Although this educational session overlaps with some of the content included in the intervention (e.g., sleep hygiene, stimulus control), it does not include any of the interactive features of the app.
Usual care
Inpatient multimodal rehabilitation for chronic pain lasting 2+2 weeks.
Interventions
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Digital Cognitive-behavioral therapy for insomnia (dCBT-I)
6 week sleep intervention delivered via a smartphone app while taking part in inpatient multimodal rehabilitation for chronic pain lasting 2+2 weeks.
Usual care
Inpatient multimodal rehabilitation for chronic pain lasting 2+2 weeks.
Eligibility Criteria
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Inclusion Criteria
* Insomnia Severity Index (ISI) score \>11.
Exclusion Criteria
* Individuals with work schedules that includes night shifts during the intervention
* Pregnancy
* Inadequate opportunity to sleep or living circumstances that prevent modification of sleep patterns such as having an infant
* Currently receiving psychological treatment for insomnia
* Medical history of contraindicating use of CBT-I such as epilepsy, recent cardiac surgery, and an attack phase of multiple sclerosis
18 Years
ALL
No
Sponsors
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Norwegian University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Lene Aasdahl
Role: PRINCIPAL_INVESTIGATOR
Norwegian University of Science and Technology
Solveig K Grudt
Role: STUDY_CHAIR
Norwegian University of Science and Technology
Locations
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Unicare Helsefort
Rissa, Hasselvika, Norway
Countries
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References
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Skarpsno ES, Simpson MR, Seim A, Hrozanova M, Bakoy MA, Klevanger NE, Aasdahl L. App-Delivered Cognitive-Behavioral Therapy for Insomnia Among Patients with Comorbid Musculoskeletal Complaints and Insomnia Referred to 4-Week Inpatient Multimodal Rehabilitation: Protocol for a Randomized Clinical Trial. Nat Sci Sleep. 2023 Oct 11;15:799-809. doi: 10.2147/NSS.S419520. eCollection 2023.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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496297
Identifier Type: -
Identifier Source: org_study_id