Cognitive Behavioral Therapy for Insomnia to Address Insomnia Symptoms in People With Multiple Sclerosis

NCT ID: NCT03216889

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-29

Study Completion Date

2019-08-15

Brief Summary

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The purpose of this study is to learn if cognitive behavioral therapy for insomnia (CBT-I) will improve sleep quality, fatigue, and quality of life in individuals with multiple sclerosis (MS) with symptoms of insomnia.

Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Cognitive Behavioral Therapy for Insomnia (CBT-I)

6 weeks of CBT-I.

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia

Intervention Type BEHAVIORAL

Involves attending 1 hour long sessions weekly for 6 weeks. Sessions will be one-on-one or in a group.

Control

6 weeks of stretching and thinking games.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

Involves attending 1 hour long sessions weekly for 6 weeks. Sessions will involve stretching and thinking games.

Interventions

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Cognitive Behavioral Therapy for Insomnia

Involves attending 1 hour long sessions weekly for 6 weeks. Sessions will be one-on-one or in a group.

Intervention Type BEHAVIORAL

Control

Involves attending 1 hour long sessions weekly for 6 weeks. Sessions will involve stretching and thinking games.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of MS by physician
* Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 6 months,
* ≥10 on Insomnia Severity Index
* English speaking
* Core at least 24 on the Mini-Mental State Exam (MMSE) to indicate reduced risk of dementia

Exclusion Criteria

* Known untreated sleep disorder (such as sleep apnea or restless leg syndrome)
* \>4 on STOP BANG indicating high risk of sleep apnea
* Increased risk of restless leg syndrome on Restless Legs Syndrome (RLS) Diagnosis Index
* Nervous system disorder other than MS
* Relapse and/or corticosteroid use in past 8 weeks
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Multiple Sclerosis Society

OTHER

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katie Siengsukon, PT, PhD

Role: STUDY_CHAIR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00140418

Identifier Type: -

Identifier Source: org_study_id

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