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

Overview

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.

Interventions

• Behavioral Telehealth cognitive behavioral therapy for insomnia (tCBT-I)
  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 Web-based cognitive behavioral therapy for insomnia (wCBT-I)
  Participants receive a daily e-mail reminder to access the program and to complete a sleep log for the prior night's sleep. After completing the sleep log, the daily lesson is made available. Each participant will be provided with a unique password to access the online program.
• Behavioral Treatment as usual (TAU)
  They will be encouraged to avoid starting any new treatment for their sleep unless recommended by their physician. They will be offered access to the web-based CBT-I program following the 6-month reassessment to complete if they wish.

Primary outcome measures

• Insomnia Severity Index (ISI) [Time frame: baseline, Week 6, Week 12]

Secondary outcome measures (11)

• 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]
• plasma neurofilament light (NfL) [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 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

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- Sleep, Health and Wellness Laboratory — Kansas City

Identifiers

NCT: NCT06434571 · STUDY00160591

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗