RecruitingPhase 2NCT06434571

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

Sponsor

University of Kansas Medical Center

Enrollment

90 participants

Start Date

Oct 11, 2024

Study Type

INTERVENTIONAL

Conditions

Insomnia Multiple Sclerosis

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two ways of delivering cognitive behavioral therapy for insomnia (CBT-I) — a proven, non-drug treatment for sleep problems — in people with multiple sclerosis (MS): one-on-one telehealth sessions with a therapist versus a self-guided website program. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with relapsing-remitting or secondary progressive MS, confirmed by a neurologist - You have mild to moderate disability (score ≤6 on the PDDS disability scale) - You have had difficulty falling asleep, staying asleep, or waking too early at least 3 nights per week for the past 3 months, causing distress in your daily life - You scored 10 or higher on the Insomnia Severity Index - You speak English and have at least a high school diploma (or equivalent) - You scored 31 or higher on a brief cognitive phone test **You may NOT be eligible if...** - Your sleep problems are caused by another sleep disorder (such as sleep apnea) - You have significant cognitive impairment - You do not speak English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALTelehealth 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 titration of total sleep time, introduce progressive muscle relaxation Session 5: continue upward titration of total sleep time, discuss negative sleep beliefs Session 6: assess global treatment gains, discuss relapse prevention

BEHAVIORALWeb-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.

BEHAVIORALTreatment 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.