Clinical trial NCT06434571: Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection
Official title: Comparing Telehealth-Delivered Cognitive Behavioral Therapy for Insomnia to Web-Based to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Multiple Sclerosis
Insomnia
Keywords: Cognitive behavioral therapy for insomnia
CBT-I
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I (tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection (Exploratory Aim 3), and to explore the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 4). Reassessment of outcomes will be completed after the 6-week intervention and 6 months following completion of interventions.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* Diagnosis of relapsing-remitting or secondary progressive MS based on established guidelines21 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 Telephone Interview of Cognitive Status
* 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
* If taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia, taking \< 3 months or dose has changed in past 3 months
* 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

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: baseline, Week 6, Week 12
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline, Week 6, Month 6
measure: Epworth Sleepiness Scale (ESS)
timeFrame: baseline, Week 6, Month 6
measure: Dysfunctional Beliefs About Sleep
timeFrame: baseline, Week 6, Month 6
measure: Positive Affect and Negative Affect Schedule (PANAS)
timeFrame: baseline, Week 6, Month 6
measure: Sleep Self-Efficacy Scale (SESS)
timeFrame: baseline, Week 6, Month 6
measure: Actigraphy
timeFrame: baseline, Week 6, Month 6
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: baseline, Week 6, Month 6
measure: Fatigue Severity Scale (FSS)
timeFrame: 'baseline, Week 6, Month 6
measure: Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: baseline, Week 6, Month 6
measure: Cognitive Failures Questionnaire (CFQ)
timeFrame: baseline, Week 6, Month 6
measure: plasma neurofilament light (NfL)
timeFrame: baseline, Week 6, Month 6
Other outcomes:
measure: Patient-Determined Disability Steps (PDDS)
timeFrame: baseline
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: baseline, Week 6, Month 6
measure: Generalized Anxiety Disorder Assessment (GAD-7)
timeFrame: baseline, Week 6, Month 6
measure: Adherence to CBT-I intervention
timeFrame: Each CBT-I session Week 1-6
measure: Diet quality
timeFrame: baseline
measure: Eating regularity
timeFrame: baseline, Week 6, Month 6
measure: Nighttime urination frequency
timeFrame: baseline, Week 6, Month 6
measure: PainDetect
timeFrame: baseline, Week 6, Month 6
measure: Fibromyalgia Survey Questionnaire
timeFrame: baseline, Week 6, Month 6
measure: PROMIS SF v.1.0 - Pain Intensity
timeFrame: baseline, Week 6, Month 6
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center- Sleep, Health and Wellness Laboratory
state: Kansas
Study officials:
References: