An Internet-delivered Cognitive Behavioral Intervention for Sleep Disturbance in Multiple Sclerosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Johns Hopkins University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Change in the Pittsburgh Sleep Quality Index (PSQI) total score
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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)
Outcomes
Primary Outcomes
Change in the Pittsburgh Sleep Quality Index (PSQI) total score
Time Frame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
The PSQI is a 9-item participant-reported measure that assesses sleep quality. Scores range from 0 to 21 points, with higher scores indicating poorer sleep quality. Scores ≥ 5 are clinically significant.
Change in the Insomnia Severity Index (ISI) total score
Time Frame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
The ISI is a 7-item participant-reported measure that assesses insomnia symptoms. Scores range from 0 to 28 points (each item is rated 0-4), with higher scores indicating greater insomnia. Scores ≥ 11 are clinically significant.
Change in actigraphic total sleep time (TST)
Time Frame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Wrist actigraphy devices objectively assess TST, in minutes. TSTs \< 360 min are considered clinically significant.
Change in actigraphic sleep efficiency (SE)
Time Frame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Wrist actigraphy devices objectively assess SE as a % of time asleep while in bed. SEs \< 85% are considered clinically significant.
Change in actigraphic sleep latency (SL)
Time Frame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Wrist actigraphy devices objectively assess SL, in minutes. SLs \> 30 min are considered clinically significant.
Change in actigraphic wake after sleep onset (WASO)
Time Frame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Wrist actigraphy devices objectively assess WASO, in minutes. WASOs \> 30 min are considered clinically significant.
Secondary Outcomes
- Change in the Modified Fatigue Impact Scale (MFIS) total score(Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12))
- Change in the Beck Depression Inventory - Fast Screen (BDI-FS) total score(Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12))
- Change in the MS Neuropsychological Screening Questionnaire (MSNQ) total score(Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12))
- Change in the TestMyBrain Memorizing Words (MW) score(Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12))
- Change in the TestMyBrain Memorizing Pictures (MP) score(Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12))
- Change in the TestMyBrain Matching Shapes and Numbers (MSN) score(Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12))
- Change in the TestMyBrain Fast Choices (FC) score(Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12))
- Treatment Satisfaction Scale (TSS) total score (iSLEEPms group only)(Post-intervention (Week 6))
- iSLEEPms treatment adherence (iSLEEPMS group only)(Post-intervention (Week 6))
- iSLEEPms treatment integrity (iSLEEPMS group only)(Post-intervention (Weeks 6))