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OpenTrials
Completed

NCT Number: NCT03216889

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

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.

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Key information

Conditions

Insomnia Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Dyssomnias Immune System Diseases Mental Disorders Multiple Sclerosis Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia

Behavioral

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

Control

Behavioral

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

Primary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: Change from Baseline to Week 7

    The ISI consists of 7 questions, each rated on a 0-4 scale. The range of scores on the ISI is 0-28, with a score of ≥ 10 suggesting clinical insomnia. The lower the score the less severe insomnia.

Secondary outcomes

  1. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Change from Baseline to Week 7

    The PSQI consists of 9 items within 7 sleep categories. The 7 sleep category scores are summed to form a single global score ranging from 0-21. A global score of >5 reflects poor sleep quality.

  2. Modified Fatigue Impact Scale (MFIS)

    Time frame: Change from Baseline to Week 7

    The MFIS assesses the impact of fatigue on daily activities for the month prior. The MFIS consists of 21 items with 3 subscales: physical, cognitive, and psychosocial. The score on the 21 items are scored with a range of 0-84 with a higher score indicating a greater impact of fatigue.

  3. Fatigue Severity Scale (FSS)

    Time frame: Change from Baseline to Week 7

    The FSS assesses the impact of fatigue on activities for the week prior and consists of 9 questions. The mean of the 9 scores is calculated with a range of 0-7.

  4. Multiple Sclerosis Impact Scale (MSIS)

    Time frame: Change from Baseline to Week 7

    Quality of life will be assessed using the Multiple Sclerosis Impact Scale (MSIS-29). MSIS-29 is total of 29 items scale, with subscales of physical (20 items) and psychological (9 items). Responses computed in a range from 0-100, and higher scores indicating a worse quality of life due to physical and physiological impacts of MS.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Multiple Sclerosis Society

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 13, 2017
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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