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

Official title

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

Overview

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).

Interventions

• 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 tit
• 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

Primary outcome measures

• Insomnia Severity Index (ISI) [Time frame: baseline, Week 6, Month 6]

Secondary outcome measures (10)

• Pittsburgh Sleep Quality Index (PSQI) [Time frame: baseline, Week 6, Month 6]
• Epworth Sleepiness Scale (ESS) [Time frame: baseline, Week 6, Month 6]
• Dysfunctional Beliefs About Sleep [Time frame: baseline, Week 6, Month 6]
• Positive Affect and Negative Affect Schedule (PANAS) [Time frame: baseline, Week 6, Month 6]
• Sleep Self-Efficacy Scale (SESS) [Time frame: baseline, Week 6, Month 6]
• Actigraphy [Time frame: baseline, Week 6, Month 6]
• Modified Fatigue Impact Scale (MFIS) [Time frame: baseline, Week 6, Month 6]
• Fatigue Severity Scale (FSS) [Time frame: baseline, Week 6, Month 6]
• Multiple Sclerosis Impact Scale (MSIS-29) [Time frame: baseline, Week 6, Month 6]
• Cognitive Failures Questionnaire (CFQ) [Time frame: baseline, Week 6, Month 6]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Kansas Medical Center — Kansas City

Publications

• 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 41626064

Identifiers

NCT: NCT06428006 · STUDY00160476

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗