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Behavioural Intervention

Cognitive Behavioral Therapy for Insomnia in Multiple Sclerosis (CALM Trial)

Phase 2

Recruiting

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged between 18-65 years old

Diagnosis of relapsing-remitting or secondary progressive MS verified by neurologist

Must not have

Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)

History of other nervous system disorder such as stroke or Parkinson's disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 6, month 6

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the effectiveness of cognitive behavioral therapy for insomnia (CBT-I) in improving insomnia symptoms, fatigue, and quality of life in individuals with multiple sclerosis. Insomnia is a common

Who is the study for?

This trial is for individuals aged 18-65 with relapsing-remitting or secondary progressive Multiple Sclerosis who experience insomnia symptoms at least three nights a week for the past three months. Participants should have mild-to-moderate disability, be English-speaking, and have internet access plus a suitable device.

What is being tested?

The study aims to test if Cognitive Behavioral Therapy for Insomnia (CBT-I) can improve sleep, reduce fatigue, and enhance quality of life in MS patients compared to an active control group that receives only sleep and lifestyle education.

What are the potential side effects?

Since CBT-I is a non-pharmacological therapy focusing on changing thoughts and behaviors around sleep, it typically does not involve physical side effects. However, some may experience temporary increases in anxiety or frustration as they adjust to new sleeping habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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My MS has been confirmed as relapsing-remitting or secondary progressive by a neurologist.

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My disability level is mild to moderate.

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I've had trouble sleeping at least 3 nights a week for the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an untreated sleep disorder like sleep apnea or restless legs syndrome.

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I have a history of a nervous system disorder like stroke or Parkinson's.

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I am currently undergoing treatment for sleep issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 6, month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 6, month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 6, month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Insomnia Severity Index (ISI)

Secondary study objectives

Actigraphy

Cognitive Failures Questionnaire (CFQ)

Dysfunctional Beliefs About Sleep

+7 more

Other study objectives

Adherence to CBT-I intervention

Diet quality

Eating regularity

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive behavioral therapy for insomniaExperimental Treatment1 Intervention

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.

Group II: Sleep and lifestyle educationActive Control1 Intervention

1x/week, 6 weekly 45-60 min one-on-one program via video conferencing (HIPAA-compliant Zoom) with a trained research assistant that includes gentle stretching activities for major muscle groups accompanied by sleep and lifestyle education.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive behavioral therapy for insomnia

2013

Completed Phase 3

~810

0 / 7Eligibility criteria met