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RecruitingPhase 2

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

Comparing Telehealth-Delivered Cognitive Behavioral Therapy for Insomnia to Web-Based to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults with multiple sclerosis (MS) who have trouble sleeping. It compares one-on-one video visits, a web program, and usual care to see whether cognitive behavioral therapy for insomnia (CBT-I) improves sleep, tiredness, and quality of life. CBT-I helps people change thoughts and habits that affect sleep; the study also explores whether it may help protect the brain and nerves.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18–65 years old.
  • Have relapsing-remitting or secondary progressive MS, confirmed by your neurologist.
  • Have mild to moderately severe disability, with a score of 6 or less on the PDDS disability scale.
  • Have trouble falling asleep, staying asleep, or waking too early at least 3 nights a week for 3 months. This must cause distress and affect daily life despite enough time to sleep, and not be caused by another sleep disorder.
  • Score at least 10 on the Insomnia Severity Index, a survey about sleep problems.
  • Speak English and have a high school diploma or equivalent.
  • Score at least 31 on a phone test of memory and thinking.
  • Have internet or a data plan and a computer, tablet, or smartphone.

Who can't join

  • Have an untreated sleep disorder, a STOP BANG score above 3 showing risk of sleep apnea (breathing pauses during sleep), restless legs syndrome, a sleep-wake timing disorder, or unusual behaviors during sleep.
  • Take certain sleep medicines, including benzodiazepines, non-benzodiazepines, melatonin, or medicines that act like melatonin, but started them or changed the dose within 3 months.
  • Have severe depression (PHQ-9 score of 20 or more), thoughts of suicide on that survey, severe anxiety (GAD-7 score of 15 or more), or severe mental illness such as schizophrenia or bipolar disorder.
  • Have alcohol or drug abuse now or within the past 2 years.
  • Have another nervous system disorder, such as stroke or Parkinson’s disease, or severe nerve or sensory problems that would greatly interfere with testing.
  • Are pregnant or plan to become pregnant in the next 6 months.
  • Have had an MS relapse or used corticosteroid medicines in the past 8 weeks.
  • Work overnight shifts that include midnight to 4 a.m., or did so within the past 5 years; or are currently receiving treatment focused on sleep habits and behaviors.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

KS