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

NCT04147052 | Completed

• 2 other identifiers: IRB00116581K23HD086154
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

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

  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.

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

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

  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.

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

• Change in actigraphic total sleep time (TST)

  Wrist actigraphy devices objectively assess TST, in minutes. TSTs \< 360 min are considered clinically significant.

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

• Change in actigraphic sleep efficiency (SE)

  Wrist actigraphy devices objectively assess SE as a % of time asleep while in bed. SEs \< 85% are considered clinically significant.

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

• Change in actigraphic sleep latency (SL)

  Wrist actigraphy devices objectively assess SL, in minutes. SLs \> 30 min are considered clinically significant.

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

• Change in actigraphic wake after sleep onset (WASO)

  Wrist actigraphy devices objectively assess WASO, in minutes. WASOs \> 30 min are considered clinically significant.

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

Secondary Outcomes (10)

• 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)

Study Arms (2)

iSLEEPms

EXPERIMENTAL

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

Behavioral: iSLEEPms

Treatment As Usual

NO INTERVENTION

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.

Interventions

iSLEEPms 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.

iSLEEPms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21211, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Abbey J Hughes

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 31, 2019
• Study Start: September 3, 2021
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: May 9, 2022

Record last verified: 2022-05

Locations

US (1)