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

Johns Hopkins University

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: iSLEEPms

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04147052

IRB00116581

K23HD086154 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

iSLEEPms

Experimental group

Description:

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

Treatment:

Behavioral: iSLEEPms

Treatment As Usual

No Intervention group

Description:

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.