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

NCT05572697 | Completed

• 1 other identifier: 496297
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic; Insomnia

Outcome Measures

Primary Outcomes (1)

• Insomnia

  Degree of sleep problems measured by the insomnia severity index (ISI).

  3 months of follow-up

Secondary Outcomes (9)

• Insomnia

  Measured at 3, 6 and 12 months of follow-up, main assessment at 3 months

• Insomnia

  6 and 12 months of follow-up

• Health-related quality of life

  3, 6 and 12 months of follow-up, main assessment at 3 months

• Pain intensity

  3, 6 and 12 months of follow-up, main assessment at 3 months

• Sick leave

  12 months of follow-up

Study Arms (2)

Digital Cognitive-behavioral therapy for insomnia (dCBT-I)

EXPERIMENTAL

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)

Usual care

ACTIVE COMPARATOR

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

Interventions

Usual care BEHAVIORAL

Inpatient multimodal rehabilitation for chronic pain lasting 2+2 weeks.

Usual care

Digital Cognitive-behavioral therapy for insomnia (dCBT-I) BEHAVIORAL

6 week sleep intervention delivered via a smartphone app while taking part in inpatient multimodal rehabilitation for chronic pain lasting 2+2 weeks.

Digital Cognitive-behavioral therapy for insomnia (dCBT-I)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Taking part in inpatient rehabilitation due to long-term musculoskeletal complaints
• Insomnia Severity Index (ISI) score \>11.

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead

Study Sites (1)

Unicare Helsefort

Rissa, Hasselvika, 7112, Norway

Location

Related Publications (1)

• 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.

  PMID: 37850197 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lene Aasdahl

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

• Solveig K Grudt

  Norwegian University of Science and Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Outcomes will be measured by registry data and questionnaires. Researchers will not have access to the randomization key before analyses are performed but blinding is not possible due to different number of participants in the two groups (as randomization is 2:1). The randomization procedure will be performed by the Clinical Research Unit (Klinforsk) at The Faculty of Medicine and Health Sciences at the Norwegian University of Science and Technology (NTNU) by use of a computer-generated block randomization. The randomization will be on group level to avoid contamination between participants in the same rehabilitation group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized clinical trial with two parallel arms

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 10, 2022
• Study Start: October 7, 2022
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)