NCT06428006Active, not recruitingPhase 2
Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis
Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms and Fatigue in Individuals With Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
The incidence of insomnia is estimated to be as high as 90% in individuals with MS due to insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated with reduced cognitive performance, physical function, psychological well-being, quality of life, and occupational function, as well as increased prevalence of fatigue, pain, depression, and anxiety. The objective of the proposed study is to determine the efficacy of cognitive behavioral therapy for insomnia (CBT-I) to improve insomnia symptoms (Aim 1) fatigue, and health-related quality of life (Aim 2) in individuals with multiple sclerosis compared to an active control group, and to determine the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 3).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 13 May 2024
- Start date
- 30 Jul 2024
- Primary completion date
- 31 May 2027
- Lead sponsor
- University of Kansas Medical Center
- Diseases
- Multiple sclerosis
- NCT number
- NCT06428006
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 70
- From 30 Jul 2024 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia
- 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
Other illness
- 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
Other
- \>3 on STOP BANG indicating increased risk of sleep apnea
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
Related publications
- Cognitive behavioral therapy for insomnia for individuals with multiple sclerosis (CALM): A randomized control trial protocol.Contemp Clin Trials Commun · 2026 · PMID 41626064
This page is information, not medical advice. Discuss any trial with your doctor.