RecruitingPhase 2NCT06428006

Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis

Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms and Fatigue in Individuals With Multiple Sclerosis


Sponsor

University of Kansas Medical Center

Enrollment

70 participants

Start Date

Jul 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The incidence of insomnia is estimated to be as high as 90% in individuals with MS due to insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated with reduced cognitive performance, physical function, psychological well-being, quality of life, and occupational function, as well as increased prevalence of fatigue, pain, depression, and anxiety. The objective of the proposed study is to determine the efficacy of cognitive behavioral therapy for insomnia (CBT-I) to improve insomnia symptoms (Aim 1) fatigue, and health-related quality of life (Aim 2) in individuals with multiple sclerosis compared to an active control group, and to determine the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 3).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an online Cognitive Behavioral Therapy for Insomnia (CBT-I) program can help people with Multiple Sclerosis (MS) sleep better. CBT-I is a talking therapy that addresses habits and thoughts that make insomnia worse, and this trial delivers it online. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with relapsing-remitting or secondary progressive MS - You have mild to moderate disability from MS - You have trouble falling asleep, staying asleep, or wake too early at least 3 nights per week for the past 3 months - Your insomnia causes significant distress or affects daily functioning - You score 10 or higher on the Insomnia Severity Index - You have a high school diploma (or equivalent) - You have internet access and a computer, tablet, or smartphone - You speak English **You may NOT be eligible if...** - You have another untreated sleep disorder (like sleep apnea or restless legs syndrome) - You currently take sleeping medications (benzodiazepines, z-drugs, or melatonin) - You have severe depression (score 20+ on PHQ-9) or active thoughts of suicide - You have severe anxiety (score 15+ on GAD-7) - You have severe mental illness such as schizophrenia or bipolar disorder - You have had a relapse or used steroids in the past 8 weeks - You are currently in a behavioral sleep program - You are pregnant or plan to become pregnant in the next 6 months 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

BEHAVIORALCognitive behavioral therapy for insomnia

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

BEHAVIORALSleep and lifestyle education

The general sessions outlines are as follows with each session: Session 1: Basic sleep education, stretching exercises Session 2: Sleep hygiene education (environmental factors \& sleep positions), stretching exercises Session 3: Sleep hygiene education (lifestyle factors), stretching exercises Session 4: Diet recommendations, stretching exercises Session 5: Exercises recommendations, stretching exercises Session 6: Discus maintaining achievements \& preventing relapses, stretching exercises


Locations(1)

University of Kansas Medical Center

Kansas City, Kansas, United States

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NCT06428006


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