Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis

Last updated: August 21, 2024
Sponsor: University of Kansas Medical Center
Overall Status: Active - Recruiting

Phase

2

Condition

Insomnia

Multiple Sclerosis

Memory Loss

Treatment

Sleep and lifestyle education

Cognitive behavioral therapy for insomnia

Clinical Study ID

NCT06428006
STUDY00160476
  • Ages 18-65
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18-65 years old

  • Diagnosis of relapsing-remitting or secondary progressive MS based on establishedguidelines20 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 atleast 3 nights/week for the past 3 months with significant distress and impact onfunction despite adequate opportunity for sleep and not due to other sleep disordersas 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 readingability 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

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 oragonists for insomnia

  • Score of ≥20 on the Patient Health Questionnaire (PHQ-9) indicating severedepression 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 indicatedby 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 withtesting

  • Relapse and/or corticosteroid use in the past 8 weeks

  • History of (within 5 years) or currently conducting overnight shift work includinghours of midnight-4am

  • Currently receiving a behavioral sleep health intervention

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Sleep and lifestyle education
Phase: 2
Study Start date:
July 30, 2024
Estimated Completion Date:
May 31, 2027

Connect with a study center

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

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