NCT04147052

iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis

An Internet-delivered Cognitive Behavioral Intervention for Sleep Disturbance in Multiple Sclerosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Sleep disturbance, especially insomnia (i.e., difficulty initiating and maintaining sleep), affects over half of people with MS. Cognitive behavioral strategies have been shown to improve sleep quantity and quality in several neurologic populations (e.g., traumatic brain injury, Parkinson's disease), and cognitive behavioral therapy for insomnia (CBT-I) is considered the first-line insomnia treatment for adults in the general population. Although cognitive behavioral interventions have historically been delivered in-person, a growing body of literature supports telephone- and internet-delivered approaches. However, more work is needed to understand the effects of internet-delivered CBT-I on patient-reported and objective outcomes. This study is a pilot randomized controlled trial to test the preliminary effects of iSLEEPms, a CBT-I-based online intervention with telephone support for individuals with MS. After completing a baseline assessment (Week 1), 90 participants with MS will be randomized (1:1) to four weeks (Weeks 2-5) of iSLEEPms (intervention group) or treatment as usual (TAU; control group), and complete post-treatment (Week 6) and follow-up (Week 12) assessments. iSLEEPms participants will complete daily sleep diary forms and weekly online educational modules. TAU participants will continue usual care without access to the iSLEEPms materials. The primary outcomes will be patient-reported and actigraphic measures of sleep quality and quantity. Secondary outcomes will be treatment satisfaction, adherence, and integrity (iSLEEPms group only). Exploratory outcomes will be fatigue symptoms, depression symptoms, and cognitive function.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
BEHAVIORAL	iSLEEPms	Participants randomized to iSLEEPms complete daily online sleep diary forms and weekly online educational modules. Modules focus on typical elements of CBT-I, adapted for individuals with MS: education about sleep in MS, sleep restriction, and stimulus control; sleep hygiene and relaxation; and cognitive restructuring around sleep and coping with MS. Sleep diaries are scored each week, and feedback is provided to participants to guide adjustments to their recommended bedtimes and wake times. Telephone support is available to provide clarification around module content.

Timeline

• Start date: 2021-09-03
• Primary completion: 2022-04-20
• Completion: 2022-04-20
• First posted: 2019-10-31
• Last updated: 2022-05-09

Locations

1 site across 1 country: United States