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Recruiting Phase 2 NCT06434571

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

Trial Parameters

Condition Multiple Sclerosis
Sponsor University of Kansas Medical Center
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 90
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2024-10-11
Completion 2028-07-31
Interventions
Telehealth cognitive behavioral therapy for insomnia (tCBT-I)Web-based cognitive behavioral therapy for insomnia (wCBT-I)Treatment as usual (TAU)

Brief Summary

The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I (tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection (Exploratory Aim 3), and to explore the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 4). Reassessment of outcomes will be completed after the 6-week intervention and 6 months following completion of interventions.

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 sy

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