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Cognitive Behavioral Therapy for Insomnia in Multiple Sclerosis

This study is looking at how well Cognitive Behavioral Therapy for Insomnia (CBT-I) works to improve sleep problems in people with Multiple Sclerosis (MS). Insomnia is very common in MS and can affect many aspects of life, including thinking, physical ability, and mood. The study will compare CBT-I to another behavioral treatment called Sleep and Lifestyle Education. Researchers want to see if CBT-I can improve insomnia symptoms, fatigue, and overall quality of life. You may be able to join if you are 18-65 years old, have relapsing-remitting or secondary progressive MS with mild-to-moderate disability, and have had trouble sleeping at least three nights a week for the past three months. The study aims to enroll 70 participants.

Study design
This interventional study plans to enroll 70 participants to compare two behavioral therapies.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your insomnia symptoms will be measured at the start of the study, after 6 weeks, and again at 6 months.

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

NCT06428006

Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis

Recruiting
PHASE2Ages 18–65InterventionalTreatment
University of Kansas Medical Center
~70 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:Cognitive behavioral therapy for insomniaSleep and lifestyle education

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, Month 6

Conditions

Multiple Sclerosis
Insomnia

Explore related trials

Multiple 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

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

18-65 years old
Diagnosis of relapsing-remitting or secondary progressive MS based on established guidelines20 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 modified Telephone Interview of Cognitive Status23
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
Currently taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia
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, Month 6

    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.