Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection
- Conditions
- Multiple SclerosisInsomnia
- Interventions
- Behavioral: Treatment as usual (TAU)Behavioral: Telehealth cognitive behavioral therapy for insomnia (tCBT-I)Behavioral: Web-based cognitive behavioral therapy for insomnia (wCBT-I)
- Registration Number
- NCT06434571
- Lead Sponsor
- University of Kansas Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment as usual (TAU) Treatment as usual (TAU) The treatment as usual comparison group will be encouraged to continue with their usual care recommended by their physician and their usual activities and sleep habits during the period between baseline and 6-month reassessment. Telehealth cognitive behavioral therapy for insomnia (tCBT-I) Telehealth cognitive behavioral therapy for insomnia (tCBT-I) 1x/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. Web-based cognitive behavioral therapy for insomnia (wCBT-I) Web-based cognitive behavioral therapy for insomnia (wCBT-I) The Go!ToSleep online program is a 6-week interactive, web-based program that delivers typical CBT-I treatment techniques of stimulus control, sleep restriction, behavioral modifications, relaxation techniques and cognitive restructuring with daily lessons (41 lessons in total)
- Primary Outcome Measures
Name Time Method Insomnia Severity Index (ISI) baseline, Week 6, Week 12 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.
- Secondary Outcome Measures
Name Time Method Epworth Sleepiness Scale (ESS) baseline, Week 6, Month 6 Consists of eight scenarios of daily activity, and participants use a four-point Likert scale to rate how likely they are to doze. Score ranges 0-24 with a higher score indicating daytime sleepiness.
Pittsburgh Sleep Quality Index (PSQI) baseline, Week 6, Month 6 The PSQI consists of 9 items within 7 sleep categories. The 7 sleep category scores are summed to form a single global score ranging from 0-21. A global score of \>5 reflects poor sleep quality.
Positive Affect and Negative Affect Schedule (PANAS) baseline, Week 6, Month 6 The PANAS is a 20-item self-report questionnaire used to measure positive and negative emotions. There are two subscales (Positive Affect and Negative Affect) with 10 items each. The respondent scores how applicable a list of emotions are on a 5-point Likert scale with 1 = "Very slightly or not at all" to 5 = "Extremely". A higher score on the Positive Affect subscale indicates greater intensity of positive emotions, and a high score on Negative Affect indicate greater intensity of negative emotions.
Dysfunctional Beliefs About Sleep baseline, Week 6, Month 6 This assessment is a 10 item Likert-scale self-report questionnaire. Higher scores indicate more dysfunctional beliefs.
Actigraphy baseline, Week 6, Month 6 Participants will wear an actigraph on their non-dominant wrist for 7 nights to assess sleep/wake cycle. Mains variables of interest are sleep regularity, timing, efficiency, and duration
Multiple Sclerosis Impact Scale (MSIS-29) baseline, Week 6, Month 6 Quality of life will be assessed using the Multiple Sclerosis Impact Scale (MSIS-29). MSIS-29 is total of 29 items scale, with subscales of physical (20 items) and psychological (9 items). Responses computed in a range from 0-100, and higher scores indicating a worse quality of life due to physical and physiological impacts of MS
plasma neurofilament light (NfL) baseline, Week 6, Month 6 blood marker of axonal damage
Modified Fatigue Impact Scale (MFIS) baseline, Week 6, Month 6 The MFIS assesses the impact of fatigue on daily activities for the month prior. The MFIS consists of 21 items with 3 subscales: physical, cognitive, and psychosocial. The score on the 21 items are scored with a range of 0-84 with a higher score indicating a greater impact of fatigue.
Fatigue Severity Scale (FSS) 'baseline, Week 6, Month 6 The FSS assesses the impact of fatigue on activities for the week prior and consists of 9 questions. The mean of the 9 scores is calculated with a range of 0-7.
Cognitive Failures Questionnaire (CFQ) baseline, Week 6, Month 6 The CFQ assesses perception of cognitive abilities over the past 6 months. consists of 25 items that the individual rates on a 5-point Likert scale with 0 = "never" and 4 = "Very Often" with a summary score of 0-100 with a higher score indicating poorer perceived cognitive abilities.
Sleep Self-Efficacy Scale (SESS) baseline, Week 6, Month 6 The SESS is a 9 item self-report Likert-scale questionnaire use to identify sleep self-efficacy. Scores range from 0-45 and a higher score indicates higher sleep self-efficacy.
Trial Locations
- Locations (1)
University of Kansas Medical Center- Sleep, Health and Wellness Laboratory
🇺🇸Kansas City, Kansas, United States