App-delivered Cognitive-behavioral Therapy for Insomnia Among Patients With Musculoskeletal Complaints
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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). |
Behavioral: 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.
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| Active Comparator: 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. |
Behavioral: Usual care
Inpatient multimodal rehabilitation for chronic pain lasting 2+2 weeks.
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Outcome Measures
Primary Outcome Measures
- Insomnia [3 months of follow-up]
Degree of sleep problems measured by the insomnia severity index (ISI).
Secondary Outcome Measures
- Insomnia [6 and 12 months of follow-up]
Degree of sleep problems measured by the insomnia severity index (ISI).
- Health-related quality of life [3, 6 and 12 months of follow-up]
Measured by the EuroQol EQ5D-5L questionnaire
- Pain intensity [3, 6 and 12 months of follow-up]
Scored from 0-10 on a numeric rating scale (NRS)
- Sick leave [12 months of follow-up]
Registry data from the National Insurance Administration (NAV).
- Use of sleep and pain medications [12 months of follow-up]
Data from the national prescription registry
Eligibility Criteria
Criteria
Inclusion Criteria:
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Taking part in inpatient rehabilitation due to long-term musculoskeletal complaints
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Insomnia Severity Index (ISI) score >11.
Exclusion Criteria:
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Not having a smartphone or tablet.
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Individuals with work schedules that includes night shifts during the intervention
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Pregnancy
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Inadequate opportunity to sleep or living circumstances that prevent modification of sleep patterns such as having an infant
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Currently receiving psychological treatment for insomnia
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Medical history of contraindicating use of CBT-I such as epilepsy, recent cardiac surgery, and an attack phase of multiple sclerosis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Unicare Helsefort | Rissa | Hasselvika | Norway | 7112 |
Sponsors and Collaborators
- Norwegian University of Science and Technology
Investigators
- Principal Investigator: Lene Aasdahl, Norwegian University of Science and Technology
- Study Chair: Solveig K Grudt, Norwegian University of Science and Technology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 496297