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

Официальное название

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

Обзор

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).

Вмешательства

• Поведенческое 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
• Поведенческое 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

Первичные конечные точки

• Insomnia Severity Index (ISI) [Срок оценки: baseline, Week 6, Month 6]

Вторичные конечные точки (10)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Kansas Medical Center — Kansas City

Публикации

• 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

Идентификаторы

NCT: NCT06428006 · STUDY00160476

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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