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

Eivind Schjelderup Skarpsno; Melanie Rae Simpson; Arnfinn Seim; Maria Hrozanova; Marthe Alida Bakøy; Nina Elisabeth Klevanger; Lene Aasdahl

doi:10.2147/NSS.S419520

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.

Authors

Eivind Schjelderup Skarpsno^{1

2}, Melanie Rae Simpson¹, Arnfinn Seim^{1

3}, Maria Hrozanova¹, Marthe Alida Bakøy³, Nina Elisabeth Klevanger¹, Lene Aasdahl^{1

3}

Affiliations

¹ Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.
² Department of Neurology and Clinical Neurophysiology, St. Olavs Hospital, Trondheim, Norway.
³ Unicare Helsefort Rehabilitation Centre, Rissa, Norway.

Abstract

Background: Insomnia is prevalent among patients receiving treatment for long-term musculoskeletal complaints in inpatient rehabilitation settings. Cognitive-behavioral therapy for insomnia (CBT-I) is effective for improving sleep quality in patients with pain, but a lack of therapists often limits the capacity to use this therapy in rehabilitation programs. The aim of this randomized clinical trial (RCT) is to evaluate the effectiveness of app-delivered CBT-I adjunct to inpatient multimodal rehabilitation for individuals with comorbid musculoskeletal complaints and insomnia, compared with rehabilitation (usual care) only.

Methods: This RCT has two parallel arms: 1) inpatient multimodal rehabilitation and 2) app-delivered CBT-I adjunct to inpatient multimodal rehabilitation. Patients referred to Unicare Helsefort (Norway) with long-term chronic musculoskeletal complaints are invited to the study. Eligible and consenting participants will be randomized to the intervention and usual care at a ratio of 2:1. Assessments will be carried out at baseline (prior to randomization), 6 weeks (at the end of rehabilitation), 3 months (primary outcome), as well as 6 and 12 months after the rehabilitation. The primary outcome is insomnia severity measured at 3 months. Secondary outcomes include pain intensity, health-related quality of life, fatigue, physical function, work ability, expectations about sick leave length, sick leave, and prescribed medication. Exploratory analyses are planned to identify moderators and mediators of the effect of the app-delivered intervention.

Discussion: This RCT will provide novel knowledge about the effectiveness of app-delivered CBT-I as an adjunct to usual care among patients participating in inpatient multimodal pain rehabilitation. Regardless of the results from this trial, the results will improve our understanding of the utility of dCBT-I in the field of rehabilitation and the importance of adding sleep therapy to this patient group.

Trial registration: This trial was prospectively registered in ClinicalTrials.gov October 10, 2022 (ClinicalTrials.gov identifier: NCT05572697).

Keywords: chronic pain; digital therapy; sleep; sleeplessness.

Associated data

ClinicalTrials.gov/NCT05572697

Grants and funding

This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. No funders have been involved in designing this study.