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NCT06434571 | RECRUITING | Multiple Sclerosis

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

University of Kansas Medical Center

Information provided by (Responsible Party):

Catherine Siengsukon, PT, PhD

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.

Condition or disease

Multiple Sclerosis

Insomnia

Intervention/treatment

Telehealth cognitive behavioral therapy for insomnia (tCBT-I)

Web-based cognitive behavioral therapy for insomnia (wCBT-I)

Treatment as usual (TAU)

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 90 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Comparing Telehealth-Delivered Cognitive Behavioral Therapy for Insomnia to Web-Based to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection
Actual Study Start Date : 2024-10-11
Estimated Primary Completion Date : 2028-07-31
Estimated Study Completion Date : 2028-07-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection

Location Details

NCT06434571

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Kansas

University of Kansas Medical Center- Sleep, Health and Wellness Laboratory

Kansas City, Kansas, United States, 66160