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NCT06428006 | RECRUITING | Multiple Sclerosis

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

University of Kansas Medical Center

Information provided by (Responsible Party):

Catherine Siengsukon, PT, PhD

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).

Condition or disease

Multiple Sclerosis

Insomnia

Intervention/treatment

Cognitive behavioral therapy for insomnia

Sleep and lifestyle education

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 70 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms and Fatigue in Individuals With Multiple Sclerosis
Actual Study Start Date : 2024-07-30
Estimated Primary Completion Date : 2027-05-31
Estimated Study Completion Date : 2027-05-31

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

Location Details

NCT06428006

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How to Participate

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Locations

RECRUITING

United States, Kansas

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160