Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis
CALM
1 other identifier
interventional
70
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 multiple-sclerosis
Started Jul 2024
Typical duration for phase_2 multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2024
CompletedFirst Posted
Study publicly available on registry
May 24, 2024
CompletedStudy Start
First participant enrolled
July 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
July 20, 2025
July 1, 2025
2.8 years
May 13, 2024
July 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insomnia Severity Index (ISI)
The ISI consists of 7 questions, each rated on a 0-4 scale. The range of scores on the ISI is 0-28, with a score of ≥ 10 suggesting clinical insomnia. The lower the score the less severe insomnia.
baseline, Week 6, Month 6
Secondary Outcomes (10)
Pittsburgh Sleep Quality Index (PSQI)
baseline, Week 6, Month 6
Epworth Sleepiness Scale (ESS)
baseline, Week 6, Month 6
Dysfunctional Beliefs About Sleep
baseline, Week 6, Month 6
Positive Affect and Negative Affect Schedule (PANAS)
baseline, Week 6, Month 6
Sleep Self-Efficacy Scale (SESS)
baseline, Week 6, Month 6
- +5 more secondary outcomes
Other Outcomes (10)
Patient-Determined Disability Steps (PDDS)
baseline
Patient Health Questionnaire (PHQ-9)
baseline, Week 6, Month 6
Generalized Anxiety Disorder Assessment (GAD-7)
baseline, Week 6, Month 6
- +7 more other outcomes
Study Arms (2)
Cognitive behavioral therapy for insomnia
EXPERIMENTAL1x/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.
Sleep and lifestyle education
ACTIVE COMPARATOR1x/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
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Related Publications (1)
Siengsukon CF, Robichaud J, Nelson E, Glaser A, Baber GR, Gratton MKP, Zanotto A, Phadnis MA, Lynch S. Cognitive behavioral therapy for insomnia for individuals with multiple sclerosis (CALM): A randomized control trial protocol. Contemp Clin Trials Commun. 2026 Jan 10;49:101595. doi: 10.1016/j.conctc.2026.101595. eCollection 2026 Feb.
PMID: 41626064DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 13, 2024
First Posted
May 24, 2024
Study Start
July 30, 2024
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
July 20, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share