App-delivered Cognitive-behavioral Therapy for Insomnia Among Patients With Musculoskeletal Complaints

Study Overview
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Brief Summary
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The aim of this randomized clinical trial is to evaluate the effectiveness of app-delivered cognitive-behavioral therapy for insomnia adjunct to inpatient multimodal rehabilitation for individuals with comorbid insomnia and chronic pain, compared with rehabilitation (usual care) only.

Detailed Description
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Insomnia is highly prevalent among patients receiving treatment for long-term musculoskeletal complains. Cognitive-behavioral therapy for insomnia (CBT-I) may be effective for improving sleep quality and pain-related outcomes in these patients, but the availability of this therapy is limited by few trained therapists. In this randomized clinical trial we will evaluate the effectiveness of app-delivered CBT-I adjunct to inpatients multimodal rehabilitation for individuals with comorbid insomnia and chronic pain, compared with rehabilitation (usual care) only. Patients referred to Unicare Helsefort (Norway) with long-term chronic musculoskeletal complains and insomnia are invited to the study. The rehabilitation program consists of 2+2 weeks of inpatient multimodal rehabilitation, where the patients are at home for two weeks between the rehabilitation stays. Participants in the intervention group will receive the (CBT-I) while participating in rehabilitation, while the control group will receive rehabilitation without the app (usual care). 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.

Official Title
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App-delivered Cognitive-behavioral Therapy for Insomnia Among Patients With Comorbid Musculoskeletal Complaints and Insomnia Referred to 4-week Inpatient Multimodal Rehabilitation

Conditions
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Insomnia, Pain, Chronic

Intervention / Treatment
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* Behavioral: Digital Cognitive-behavioral therapy for insomnia (dCBT-I)
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Taking part in inpatient rehabilitation due to long-term musculoskeletal complaints Insomnia Severity Index (ISI) score >11. Exclusion Criteria: Not having a smartphone or tablet. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized clinical trial with two parallel arms
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Cognitive-behavioral therapy for insomnia (dCBT-I)<br>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). | Behavioral: Digital Cognitive-behavioral therapy for insomnia (dCBT-I)<br>* 6 week sleep intervention delivered via a smartphone app while taking part in inpatient multimodal rehabilitation for chronic pain lasting 2+2 weeks.<br>|
| Active Comparator: Usual care<br>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. | Behavioral: Usual care<br>* Inpatient multimodal rehabilitation for chronic pain lasting 2+2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia | Degree of sleep problems measured by the insomnia severity index (ISI). | 3 months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia | Degree of sleep problems measured by the insomnia severity index (ISI). | 6 and 12 months of follow-up | 
| Health-related quality of life | Measured by the EuroQol EQ5D-5L questionnaire | 3, 6 and 12 months of follow-up | 
| Pain intensity | Scored from 0-100 on a visual analogue scale | 3, 6 and 12 months of follow-up | 
| Sick leave | Registry data from the National Insurance Administration (NAV). | 12 months of follow-up | 
| Use of sleep and pain medications | Data from the national prescription registry | 12 months of follow-up | 
| Physical function | Measured by the Patient-Specific Functional Scale (PSFS). Scored 0-10. | 3, 6 and 12 months of follow-up | 
| Fatigue | Scored from 0-100 on a visual analogue scale | 3, 6 and 12 months of follow-up | 
| Work ability | Measured by the work ability index single item (self- assessed work ability on a 0-10 scale) | 3, 6 and 12 months of follow-up | 
| Expectations about length of sick leave | Single item What are the chances that you are back at work in 6 months? on a 0-10 scale | 3, 6 and 12 months of follow-up |