iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in

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

CompletedNot a drug-phase studyMS (type not specified)NCT04147052

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 4 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • iSLEEPms

What it measured

Main measures

  • Change in the Pittsburgh Sleep Quality Index (PSQI) total score

    Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)

    Mood and sleep

  • Change in the Insomnia Severity Index (ISI) total score

    Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)

    Mood and sleep

  • Change in actigraphic total sleep time (TST)

    Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)

    Mood and sleep

  • Change in actigraphic sleep efficiency (SE)

    Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)

    Mood and sleep

  • Change in actigraphic sleep latency (SL)

    Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)

    Myelin repairMood and sleep

  • Change in actigraphic wake after sleep onset (WASO)

    Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)

    Mood and sleep

Other measures (10)

  • Change in the Modified Fatigue Impact Scale (MFIS) total score

    Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)

    Thinking and memoryFatigue

  • Change in the Beck Depression Inventory - Fast Screen (BDI-FS) total score

    Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)

    Mood and sleep

  • Change in the MS Neuropsychological Screening Questionnaire (MSNQ) total score

    Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)

    Thinking and memory

  • Change in the TestMyBrain Memorizing Words (MW) score

    Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)

    Thinking and memory

  • Change in the TestMyBrain Memorizing Pictures (MP) score

    Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)

    Thinking and memory

  • Change in the TestMyBrain Matching Shapes and Numbers (MSN) score

    Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)

    Thinking and memory

  • Change in the TestMyBrain Fast Choices (FC) score

    Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)

    Thinking and memory

  • Treatment Satisfaction Scale (TSS) total score (iSLEEPms group only)

    Post-intervention (Week 6)

    Mood and sleepQuality of life (reported by participants)

  • iSLEEPms treatment adherence (iSLEEPMS group only)

    Post-intervention (Week 6)

    Mood and sleepQuality of life (reported by participants)

  • iSLEEPms treatment integrity (iSLEEPMS group only)

    Post-intervention (Weeks 6)

    Mood and sleepQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 and over

Show the full 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)

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Sept 2021

    2. Main results due

      Apr 2022

    3. Finished

      Apr 2022

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