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

NCT ID: NCT04147052

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-03
• Study Completion Date: 2022-04-20

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

iSLEEPms

Participants randomized to iSLEEPms complete a 4-week online program with telephone support, based on CBT-I.

Group Type: EXPERIMENTAL

iSLEEPms

Intervention Type: BEHAVIORAL

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.

Treatment As Usual

Participants randomized to TAU continue their usual care and are encouraged to avoid starting any new sleep treatment unless deemed necessary by a health care provider.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Ages 18 and older
• MS diagnosis56 of at least 1 year duration
• Able to speak and read English
• Sleep disturbance as indicated by an ISI score of at least 11
• Willingness to commit to a 4-week intervention and 12-week follow-up assessment

Exclusion Criteria

• Neurological disorder other than MS
• Hazardous alcohol use, as indicated by the Alcohol Use Disorders Identification Test (AUDIT-C)
• Hazardous substance use, as indicated by the Drug Abuse Screening Test (DAST-10)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abbey J Hughes

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

K23HD086154

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00116581

Identifier Type: -

Identifier Source: org_study_id