Clinical trial NCT04147052: iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis
Official title: An Internet-delivered Cognitive Behavioral Intervention for Sleep Disturbance in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-10-31
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change in the Pittsburgh Sleep Quality Index (PSQI) total score
timeFrame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
measure: Change in the Insomnia Severity Index (ISI) total score
timeFrame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
measure: Change in actigraphic total sleep time (TST)
timeFrame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
measure: Change in actigraphic sleep efficiency (SE)
timeFrame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
measure: Change in actigraphic sleep latency (SL)
timeFrame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
measure: Change in actigraphic wake after sleep onset (WASO)
timeFrame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Secondary outcomes:
measure: Change in the Modified Fatigue Impact Scale (MFIS) total score
timeFrame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
measure: Change in the Beck Depression Inventory - Fast Screen (BDI-FS) total score
timeFrame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
measure: Change in the MS Neuropsychological Screening Questionnaire (MSNQ) total score
timeFrame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
measure: Change in the TestMyBrain Memorizing Words (MW) score
timeFrame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
measure: Change in the TestMyBrain Memorizing Pictures (MP) score
timeFrame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
measure: Change in the TestMyBrain Matching Shapes and Numbers (MSN) score
timeFrame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
measure: Change in the TestMyBrain Fast Choices (FC) score
timeFrame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
measure: Treatment Satisfaction Scale (TSS) total score (iSLEEPms group only)
timeFrame: Post-intervention (Week 6)
measure: iSLEEPms treatment adherence (iSLEEPMS group only)
timeFrame: Post-intervention (Week 6)
measure: iSLEEPms treatment integrity (iSLEEPMS group only)
timeFrame: Post-intervention (Weeks 6)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Abbey J Hughes
role: PRINCIPAL_INVESTIGATOR
References: