NCT06025968

Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis

Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis: A Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trialis to compare a digital Cognitive-behavioral intervention for insomnia to digital administered applied relaxation in participants with Multiple Sclerosis. The treatments will be compared in following outcomes: * Sleep diary: total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), and early morning awakening (EMA). * Insomnia symptoms * Depressive symptoms * Client satisfaction * Negative effects * Worry * Fatigue * Quality of life * MS symptoms/function

Detailed description

In order to start evaluate the digital treatment format, this study will use a Randomized Controlled Trial design (RCT). Participants with MS and insomnia from a Neurology clinic in Sweden will be randomized to either Cognitive-behavioral intervention for insomnia (iCBT) or Applied relaxation (AR). The treatments will consits of six sessions and will be administered digitally. Psychologists will have contact with the participants via a secure video call platform.Follow-up data will be gathered at six and 12 months after the treatments. The treatments will be compared in following outcomes: * Sleep diary: total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), and early morning awakening (EMA). * Insomnia symptoms * Depressive symptoms * Worry * Fatigue * Quality of life * MS symptoms/function * Client satisfaction * Negative effects

Conditions

• Multiple Sclerosis
• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	i-CBT	The content is based on manual by Perlis et al (2015) and has slightly reworked by the research team by shortening treatment from seven to six sessions and allowing for day-time naps that may be necessary for patient with MS (Siengsukon et al. 2020). Due to the high prevalence of fatigue in people with MS, naps during the day may be a necessity to cope with everyday tasks. In cases where patients could not refrain from naps, they were advised to limit them to maximum 20 minutes and to take them as early in the day as possible. Other components are sleep restriction, sleep hygiene, stimulus control and cognitive techniques..
BEHAVIORAL	Applied relaxation	Treatment consits of 6 modules. The main components in the training program will be progressive muscle relaxation, short relaxation with release only and without tension, and finally the participants will be taught rapid relaxation.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-01-01
• Completion: 2025-09-01
• First posted: 2023-09-06
• Last updated: 2023-09-06

Locations

1 site across 1 country: Sweden