Telehealth CBT-I for Insomnia in Multiple Sclerosis

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
Who this trial is looking for

This trial is looking for adults with multiple sclerosis who have trouble sleeping. Participants will receive either one-on-one telehealth therapy or use a web-based program to help improve their sleep over six weeks.

Are You a Good Fit for This Trial?
Must not be taking BenzodiazepinesNon-benzodiazepinesMelatonin
Rules you out Severe mental illnessSevere neurological impairments

You may be able to join if

  • I am between 18 and 65 years old.
  • I have been diagnosed with relapsing-remitting or secondary progressive MS.
  • I have mild-to-moderately severe disability.
  • I have trouble sleeping at least 3 nights a week for the last 3 months.
  • I score 10 or more on the Insomnia Severity Index.
  • I speak English.
  • I have access to the internet and a device to participate.

You may not be able to join if

  • I have a known untreated sleep disorder.
  • I score more than 3 on the STOP BANG questionnaire.
  • I have been diagnosed with restless legs syndrome.
  • I have severe depression or suicidal thoughts.
  • I have severe anxiety.
  • I currently abuse alcohol or drugs.
  • I have a history of serious nervous system issues.
  • I am currently pregnant or planning to become pregnant.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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