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

Launched by UNIVERSITY OF KANSAS MEDICAL CENTER · May 23, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to help people with multiple sclerosis (MS) who struggle with sleep problems, also known as insomnia. The study will compare one-on-one telehealth sessions called telehealth Cognitive Behavioral Therapy for Insomnia (tCBT-I) to a web-based program (wCBT-I) and standard care to see which method better improves sleep, reduces fatigue, and enhances overall quality of life. Researchers will also explore how these treatments may help protect the brain over time and identify what factors in participants might predict improvements in their sleep quality.

To participate in the trial, individuals should be between 18 and 65 years old, have a confirmed diagnosis of relapsing-remitting or secondary progressive MS, and experience sleep difficulties at least three times a week. Participants must also have access to the internet and a device like a computer or smartphone. The study involves a 6-week intervention period, followed by follow-up assessments at 6 months to see how effective the treatments were. It's important to note that certain conditions, like untreated sleep disorders or severe mental health issues, may exclude individuals from participating. Participants can expect to engage in therapy sessions either online or through a web platform to help improve their sleep and overall well-being.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 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
• • 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