Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection (CLEAR)

University of Kansas

Status and phase: Enrolling; Phase 2

Conditions: Multiple Sclerosis; Insomnia

Treatments: Behavioral: Telehealth cognitive behavioral therapy for insomnia (tCBT-I); Behavioral: Web-based cognitive behavioral therapy for insomnia (wCBT-I); Behavioral: Treatment as usual (TAU)

Study type: Interventional

Funder types: Other

Identifiers

NCT06434571

STUDY00160591

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Telehealth cognitive behavioral therapy for insomnia (tCBT-I)

Experimental group

Description:

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.

Treatment:

Behavioral: Telehealth cognitive behavioral therapy for insomnia (tCBT-I)

Web-based cognitive behavioral therapy for insomnia (wCBT-I)

Experimental group

Description:

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)

Treatment:

Behavioral: Web-based cognitive behavioral therapy for insomnia (wCBT-I)

Treatment as usual (TAU)

Other group

Description:

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.

Treatment:

Behavioral: Treatment as usual (TAU)