Back to search results

Comparing Telehealth and Web-Based CBT-I for Multiple Sclerosis and Insomnia

This study is comparing different ways to help people with Multiple Sclerosis (MS) who also have trouble sleeping (insomnia). It's looking at two types of cognitive behavioral therapy for insomnia (CBT-I): one-on-one telehealth CBT-I (tCBT-I) and web-based CBT-I (wCBT-I). It will also compare these to a group receiving "treatment as usual" (TAU), meaning they won't start new sleep treatments unless their doctor recommends it. The goal is to see which approach best improves sleep, reduces tiredness, and potentially protects the brain. You might be able to join if you are 18-65 years old, have relapsing-remitting or secondary progressive MS, and experience difficulty sleeping at least three nights a week for the past three months. The study will measure how much your sleep improves using a tool called the Insomnia Severity Index.

Study design
This is an interventional study planning to enroll 90 participants. It compares three different behavioral interventions.
What's involved
Participants will receive either telehealth CBT-I, web-based CBT-I, or treatment as usual for 6 weeks. They will also complete sleep logs and have reassessments after 6 weeks and 6 months.
Compensation
Not stated in the trial record.
Follow-up
Outcomes will be reassessed after the 6-week intervention and 6 months after the interventions are completed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06434571

Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection

Recruiting
PHASE2Ages 18–65InterventionalTreatment
University of Kansas Medical Center
~90 participants
Updated 2025-10-09 on ClinicalTrials.gov
What's tested:Telehealth cognitive behavioral therapy for insomnia (tCBT-I)Web-based cognitive behavioral therapy for insomnia (wCBT-I)Treatment as usual (TAU)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Insomnia Severity Index (ISI)
Measured over baseline, Week 6, Week 12

Conditions

Multiple Sclerosis
Insomnia

Explore related trials

InsomniaMultiple Sclerosis

Where it's being run

1 sites across 1 states
Kansas1

Who to contact

Eryen Nelson, MPH
[email protected]
913-945-7349
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Exclusion

Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)
\>3 on STOP BANG indicating increased risk of sleep apnea
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
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)
Score of ≥15 on the Generalized Anxiety Disorder (GAD-7) indicating severe anxiety
Current or history (up to 2 years) of alcohol or drug or alcohol abuse as indicated by DSM-5 criteria
History of other nervous system disorder such as stroke or Parkinson's disease
Currently pregnant or intending to become pregnant in the next 6 months
Severe mental illness such as schizophrenia or bipolar disorder
Severe neurological or sensory impairments that would interfere significantly with testing
Relapse and/or corticosteroid use in the past 8 weeks
History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am
Currently receiving a behavioral sleep health intervention

What this trial measures

  • Insomnia Severity Index (ISI)baseline, Week 6, Week 12

    The ISI consists of 7 questions, each rated on a 0-4 scale. The range of scores on the ISI is 0-28, with a score of ≥ 10 suggesting clinical insomnia. The lower the score the less severe insomnia.