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

NCT ID: NCT06428006

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-30
• Study Completion Date: 2027-05-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive behavioral therapy for insomnia

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Sleep and lifestyle education

Intervention Type: BEHAVIORAL

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

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Catherine Siengsukon, PT, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Eryen Nelson, MPH

Role: CONTACT

enelson5@kumc.edu

913-945-7349

Catherine Siengsukon, PhD

Role: CONTACT

csiengsukon@kumc.edu

913-588-6913

Other Identifiers

STUDY00160476

Identifier Type: -

Identifier Source: org_study_id