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

Phase 2

Not yet recruiting

• Conditions: Multiple Sclerosis; Insomnia

• Registration Number: NCT06434571
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-5-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Inclusion Criteria:<br><br> - 18-65 years old<br><br> - Diagnosis of relapsing-remitting or secondary progressive MS based on established<br> guidelines21 and verified by their neurologist<br><br> - Mild-to-moderately severe disability (= 6 on Patient Determined Disability Steps<br> (PDDS) scale)<br><br> - Report of difficulty falling asleep, maintaining sleep, or waking up too early at<br> least 3 nights/week for the past 3 months with significant distress and impact on<br> function despite adequate opportunity for sleep and not due to other sleep disorders<br> as indicated in the DSM-5<br><br> - =10 on Insomnia Severity Index<br><br> - English speaking<br><br> - =31 on Telephone Interview of Cognitive Status<br><br> - Has a high school diploma or equivalent to serve as a proxy measurement of reading<br> ability to ensure adequate reading ability to participate in the study<br><br> - Report having access to internet service or a data plan and access to a computer,<br> tablet, or smart phone<br><br>Exclusion Criteria:<br><br> - Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)<br><br> - >3 on STOP BANG indicating increased risk of sleep apnea<br><br> - Restless legs syndrome as determined by RLS-Diagnosis Index<br><br> - Circadian rhythm sleep-wake disorder as determined by the Sleep Disorders-Revised<br><br> - Parasomnia as determined by the Sleep Disorders-Revised<br><br> - If taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists<br> for insomnia, taking < 3 months or dose has changed in past 3 months<br><br> - Score of =20 on the Patient Health Questionnaire (PHQ-9) indicating severe<br> depression or endorsement of suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)<br><br> - Score of =15 on the Generalized Anxiety Disorder (GAD-7) indicating severe anxiety<br><br> - Current or history (up to 2 years) of alcohol or drug or alcohol abuse as indicated<br> by DSM-5 criteria<br><br> - History of other nervous system disorder such as stroke or Parkinson's disease<br><br> - Currently pregnant or intending to become pregnant in the next 6 months<br><br> - Severe mental illness such as schizophrenia or bipolar disorder<br><br> - Severe neurological or sensory impairments that would interfere significantly with<br> testing<br><br> - Relapse and/or corticosteroid use in the past 8 weeks<br><br> - History of (within 5 years) or currently conducting overnight shift work including<br> hours of midnight-4am<br><br> - Currently receiving a behavioral sleep health intervention

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI)

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index (PSQI);Epworth Sleepiness Scale (ESS);Dysfunctional Beliefs About Sleep;Positive Affect and Negative Affect Schedule (PANAS);Sleep Self-Efficacy Scale (SESS);Actigraphy;Modified Fatigue Impact Scale (MFIS);Fatigue Severity Scale (FSS);Multiple Sclerosis Impact Scale (MSIS-29);Cognitive Failures Questionnaire (CFQ);plasma neurofilament light (NfL)