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Taking people in United StatesPhase 2

Comparing two sleep therapy delivery methods for people with multiple sclerosis

Tests video and online sleep therapy against usual care in adults with multiple sclerosis.

Key facts

Who runs it
University of Kansas Medical Center
Where
Kansas City, United StatesSee the site
Trial code
Registry title
Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection
Status
Recruiting
Phase
Phase 2
People taking part
90 people, planned
Started
11 Oct 2024
Expected to end
31 Jul 2028
Type of study
Interventional, 3 groups
Treatments tested
  • Telehealth cognitive behavioral therapy for insomnia (tCBT-I)
  • Web-based cognitive behavioral therapy for insomnia (wCBT-I)
  • Treatment as usual (TAU)
Record updated
13 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with relapsing-remitting or secondary progressive multiple sclerosis who also have insomnia. It compares two kinds of cognitive behavioral therapy for sleep with usual care.

Age
18 to 65 years
Sex
All sexes can join.
Disease stage
Relapsing-remitting or secondary progressive multiple sclerosis, confirmed by a neurologist. Mild-to-moderately severe disability (6 or less on the PDDS scale). Insomnia at least 3 nights a week for the past 3 months, with a score of 10 or more on the Insomnia Severity Index.
Earlier treatment
People who take benzodiazepines, non-benzodiazepines or melatonin for insomnia can join only if they have taken them for 3 months or more with no dose change in the past 3 months. People currently receiving a behavioral sleep health intervention cannot join. No relapse or corticosteroid use in the past 8 weeks.

Main reasons for not taking part

  • Known untreated sleep disorder such as sleep apnea or restless legs syndrome
  • Severe depression, suicidal thoughts or severe anxiety
  • Alcohol or drug abuse now or in the past 2 years
  • Other nervous system disorder such as stroke or Parkinson's disease, or severe mental illness
  • Currently pregnant or planning pregnancy in the next 6 months

The registry criteria, word for word

Show all 25 criteriaShow less

Who can take part

  • 18-65 years old
  • Diagnosis of relapsing-remitting or secondary progressive MS based on established guidelines21 and verified by their neurologist
  • Mild-to-moderately severe disability (≤ 6 on Patient Determined Disability Steps (PDDS) scale)
  • Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 3 months with significant distress and impact on function despite adequate opportunity for sleep and not due to other sleep disorders as indicated in the DSM-5
  • ≥10 on Insomnia Severity Index
  • English speaking
  • ≥31 on Telephone Interview of Cognitive Status
  • Has a high school diploma or equivalent to serve as a proxy measurement of reading ability to ensure adequate reading ability to participate in the study
  • Report having access to internet service or a data plan and access to a computer, tablet, or smart phone

Who cannot take part

  • Current or history (up to 2 years) of alcohol or drug or alcohol abuse as indicated by DSM-5 criteria
  • Relapse and/or corticosteroid use in the past 8 weeks
  • Currently receiving a behavioral sleep health intervention
  • Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)
  • Restless legs syndrome as determined by RLS-Diagnosis Index
  • Circadian rhythm sleep-wake disorder as determined by the Sleep Disorders-Revised
  • Parasomnia as determined by the Sleep Disorders-Revised
  • Score of ≥15 on the Generalized Anxiety Disorder (GAD-7) indicating severe anxiety
  • History of other nervous system disorder such as stroke or Parkinson's disease
  • Severe mental illness such as schizophrenia or bipolar disorder
  • History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am
  • >3 on STOP BANG indicating increased risk of sleep apnea
  • If taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia, taking < 3 months or dose has changed in past 3 months
  • Score of ≥20 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)
  • Currently pregnant or intending to become pregnant in the next 6 months
  • Severe neurological or sensory impairments that would interfere significantly with testing

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in United States

  • University of Kansas Medical Center- Sleep, Health and Wellness LaboratoryKansas City, United StatesContact: Eryen Nelson, MPHTaking people

About the trial

What the trial wants to find out

The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I (tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection (Exploratory Aim 3), and to explore the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 4). Reassessment of outcomes will be completed after the 6-week intervention and 6 months following completion of interventions.

The 3 groups in the trial

  • Telehealth cognitive behavioral therapy for insomnia (tCBT-I)Treatment being tested

    1x/week, 6-week 45-60 min one-one-one manualized program via video conferencing (HIPAA-compliant Zoom) with a trained research assistant that includes time in bed restriction, stimulus control, relaxation strategies, cognitive restructuring, and sleep health promotion education.

  • Web-based cognitive behavioral therapy for insomnia (wCBT-I)Treatment being tested

    The Go!ToSleep online program is a 6-week interactive, web-based program that delivers typical CBT-I treatment techniques of stimulus control, sleep restriction, behavioral modifications, relaxation techniques and cognitive restructuring with daily lessons (41 lessons in total)

  • Treatment as usual (TAU)Other group

    The treatment as usual comparison group will be encouraged to continue with their usual care recommended by their physician and their usual activities and sleep habits during the period between baseline and 6-month reassessment.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Comparing Telehealth-Delivered Cognitive Behavioral Therapy for Insomnia to Web-Based to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection
Plain-language title
Comparing two sleep therapy delivery methods for people with multiple sclerosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06434571, who can take part
Record updated
13 October 2026