RECRUITING

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

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Conditions

Multiple SclerosisInsomniaCognitive behavioral therapy for insomniaCBT-I

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Comparing Telehealth-Delivered Cognitive Behavioral Therapy for Insomnia to Web-Based to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection

Quick Facts

Study Start:2024-10-11
Study Completion:2028-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06434571

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-65 years old
  2. * Diagnosis of relapsing-remitting or secondary progressive MS based on established guidelines21 and verified by their neurologist
  3. * Mild-to-moderately severe disability (≤ 6 on Patient Determined Disability Steps (PDDS) scale)
  4. * 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
  5. * ≥10 on Insomnia Severity Index
  6. * English speaking
  7. * ≥31 on Telephone Interview of Cognitive Status
  8. * 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
  9. * Report having access to internet service or a data plan and access to a computer, tablet, or smart phone
  1. * Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)
  2. * \>3 on STOP BANG indicating increased risk of sleep apnea
  3. * Restless legs syndrome as determined by RLS-Diagnosis Index
  4. * Circadian rhythm sleep-wake disorder as determined by the Sleep Disorders-Revised
  5. * Parasomnia as determined by the Sleep Disorders-Revised
  6. * If taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia, taking \< 3 months or dose has changed in past 3 months
  7. * 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)
  8. * Score of ≥15 on the Generalized Anxiety Disorder (GAD-7) indicating severe anxiety
  9. * Current or history (up to 2 years) of alcohol or drug or alcohol abuse as indicated by DSM-5 criteria
  10. * History of other nervous system disorder such as stroke or Parkinson's disease
  11. * Currently pregnant or intending to become pregnant in the next 6 months
  12. * Severe mental illness such as schizophrenia or bipolar disorder
  13. * Severe neurological or sensory impairments that would interfere significantly with testing
  14. * Relapse and/or corticosteroid use in the past 8 weeks
  15. * History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am
  16. * Currently receiving a behavioral sleep health intervention

Contacts and Locations

Study Contact

Eryen Nelson, MPH
CONTACT
913-945-7349
enelson5@kumc.edu
Catherine Siengsukon, PhD
CONTACT
913-588-6913
csiengsukon@kumc.edu

Study Locations (Sites)

University of Kansas Medical Center- Sleep, Health and Wellness Laboratory
Kansas City, Kansas, 66160
United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-11
Study Completion Date2028-07-31

Study Record Updates

Study Start Date2024-10-11
Study Completion Date2028-07-31

Terms related to this study

Keywords Provided by Researchers

  • Cognitive behavioral therapy for insomnia
  • CBT-I

Additional Relevant MeSH Terms

  • Multiple Sclerosis
  • Insomnia