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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Behavioral: 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
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.
  • Behavioral: 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

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160

More Details

Status
Recruiting
Sponsor
University of Kansas Medical Center

Study Contact

Eryen Nelson, MPH
913-945-7349
enelson5@kumc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.