Recruiting
Phase 2

Cognitive Behavioral Therapy

Sponsor:

University of Kansas Medical Center

Code:

NCT06428006

Conditions

Multiple Sclerosis

Insomnia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Cognitive behavioral therapy for insomnia

Sleep and lifestyle education

Study Details

Brief summary:

The incidence of insomnia is estimated to be as high as 90% in individuals with MS due to insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated with reduced cognitive performance, physical function, psychological well-being, quality of life, and occupational function, as well as increased prevalence of fatigue, pain, depression, and anxiety. The objective of the proposed study is to determine the efficacy of cognitive behavioral therapy for insomnia (CBT-I) to improve insomnia symptoms (Aim 1) fatigue, and health-related quality of life (Aim 2) in individuals with multiple sclerosis compared to an active control group, and to determine the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 3).

Conditions

Multiple Sclerosis

Insomnia

Study ID

NCT06428006

Start date

Jul 30, 2024

Status verified date

Jun, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

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 guidelines20 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 modified Telephone Interview of Cognitive Status23
  • 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
  • Currently taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia
  • 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

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cognitive behavioral therapy for insomnia

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.

active comparator: Sleep and lifestyle education

1x/week, 6 weekly 45-60 min one-on-one program via video conferencing (HIPAA-compliant Zoom) with a trained research assistant that includes gentle stretching activities for major muscle groups accompanied by sleep and lifestyle education.

Interventions

Cognitive behavioral therapy for insomnia

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

Sleep and lifestyle education

The general sessions outlines are as follows with each session:

Session 1: Basic sleep education, stretching exercises Session 2: Sleep hygiene education (environmental factors \& sleep positions), stretching exercises Session 3: Sleep hygiene education (lifestyle factors), stretching exercises Session 4: Diet recommendations, stretching exercises Session 5: Exercises recommendations, stretching exercises Session 6: Discus maintaining achievements \& preventing relapses, stretching exercises

Primary outcome measure

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

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

Recruiting

Kansas City, Kansas, United States, 66160

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

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 2026-06-12.