Recruiting
Phase 2

Telehealth & Web-Based CBT-I

Sponsor:

University of Kansas Medical Center

Code:

NCT06434571

Conditions

Multiple Sclerosis

Insomnia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Telehealth cognitive behavioral therapy for insomnia (tCBT-I)

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

Treatment as usual (TAU)

Study Details

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.

Conditions

Multiple Sclerosis

Insomnia

Study ID

NCT06434571

Start date

Oct 11, 2024

Status verified date

Oct, 2025

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Telehealth cognitive behavioral therapy for insomnia (tCBT-I)

1x/week, 6-week 45-60 min one-one-one manualized program via video conferencing (HIPAA-compliant Zoom) with a trained research assistant that includes time in bed restriction, stimulus control, relaxation strategies, cognitive restructuring, and sleep health promotion education.

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

The Go!ToSleep online program is a 6-week interactive, web-based program that delivers typical CBT-I treatment techniques of stimulus control, sleep restriction, behavioral modifications, relaxation techniques and cognitive restructuring with daily lessons (41 lessons in total)

other: Treatment as usual (TAU)

The treatment as usual comparison group will be encouraged to continue with their usual care recommended by their physician and their usual activities and sleep habits during the period between baseline and 6-month reassessment.

Interventions

Telehealth cognitive behavioral therapy for insomnia (tCBT-I)

The general sessions outlines are as follows with each session:

Session 1: determine treatment plan, set up sleep schedule and stimulus control, discuss strategies for how to stay awake to prescribed hour and what to do if wake up in middle of night, sleep hygiene education Session 2: continue upward titration of total sleep time, review sleep hygiene; introduce diaphragmatic breathing Session 3: continue upward titration of total sleep time, introduce mindfulness Session 4: continue upward titration of total sleep time, introduce progressive muscle relaxation Session 5: continue upward titration of total sleep time, discuss negative sleep beliefs Session 6: assess global treatment gains, discuss relapse prevention

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

Participants receive a daily e-mail reminder to access the program and to complete a sleep log for the prior night's sleep. After completing the sleep log, the daily lesson is made available. Each participant will be provided with a unique password to access the online program.

Treatment as usual (TAU)

They will be encouraged to avoid starting any new treatment for their sleep unless recommended by their physician. They will be offered access to the web-based CBT-I program following the 6-month reassessment to complete if they wish.

Primary outcome measure

  • Insomnia Severity Index (ISI) [ Time Frame: baseline, Week 6, Week 12 ]

Central Contacts and Locations

Central contacts

Eryen Nelson, MPH

913-945-7349enelson5@kumc.edu

Catherine Siengsukon, PhD

913-588-6913csiengsukon@kumc.edu

Locations

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

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Eryen Nelson, MPH

913-945-7349enelson5@kumc.edu

Principal Investigator:

Catherine Siengsukon, PT, PhD

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Oct 9, 2025

Last verified

Oct, 2025

Keywords

  • Cognitive behavioral therapy for insomnia
  • CBT-I

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2025-10-09.