Cognitive Behavioral Therapy for Insomnia in People with Multiple Sclerosis
Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms and Fatigue in Individuals With Multiple Sclerosis
This study is testing whether cognitive behavioral therapy can help people with multiple sclerosis sleep better and feel less tired.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT06428006 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of cognitive behavioral therapy for insomnia (CBT-I) in improving sleep symptoms in individuals with multiple sclerosis (MS). It aims to compare the outcomes of CBT-I against an active control group, focusing on insomnia symptoms, fatigue, and health-related quality of life. The study also seeks to identify participant characteristics that may predict improvements in sleep outcomes. Participants will engage in therapy sessions and receive education on sleep and lifestyle changes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of relapsing-remitting or secondary progressive MS who experience insomnia symptoms.
Not a fit: Patients with untreated sleep disorders such as sleep apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve sleep quality and overall well-being for patients with multiple sclerosis.
How similar studies have performed: Previous studies have shown that cognitive behavioral therapy can be effective for treating insomnia, suggesting potential success for this approach in the MS population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Kansas City, Kansas
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Study coordinator: Eryen Nelson, MPH
- Email: enelson5@kumc.edu
- Phone: 913-945-7349
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.