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

Recruiting Phase 2 Interventional Study
Multiple Sclerosis Insomnia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
90 (estimated)
Sponsor
University of Kansas Medical Center · Other
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About This Trial
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). Reasse…
Trial Locations
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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 as…
Contacts

Eryen Nelson, MPH

913-945-7349

enelson5@kumc.edu

CONTACT

Catherine Siengsukon, PhD

913-588-6913

csiengsukon@kumc.edu

CONTACT