Cognitive Behavioral Therapy for Insomnia to Address Insomnia Symptoms in People With Multiple Sclerosis
1 other identifier
interventional
43
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 29, 2017
CompletedFirst Submitted
Initial submission to the registry
July 11, 2017
CompletedFirst Posted
Study publicly available on registry
July 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2019
CompletedAugust 28, 2019
August 1, 2019
2.1 years
July 11, 2017
August 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insomnia Severity Index (ISI)
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.
Change from Baseline to Week 7
Secondary Outcomes (4)
Pittsburgh Sleep Quality Index (PSQI)
Change from Baseline to Week 7
Modified Fatigue Impact Scale (MFIS)
Change from Baseline to Week 7
Fatigue Severity Scale (FSS)
Change from Baseline to Week 7
Multiple Sclerosis Impact Scale (MSIS)
Change from Baseline to Week 7
Study Arms (2)
Cognitive Behavioral Therapy for Insomnia (CBT-I)
EXPERIMENTAL6 weeks of CBT-I.
Control
ACTIVE COMPARATOR6 weeks of stretching and thinking games.
Interventions
Involves attending 1 hour long sessions weekly for 6 weeks. Sessions will be one-on-one or in a group.
Involves attending 1 hour long sessions weekly for 6 weeks. Sessions will involve stretching and thinking games.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Katie Siengsukon, PT, PhD
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2017
First Posted
July 13, 2017
Study Start
June 29, 2017
Primary Completion
August 15, 2019
Study Completion
August 15, 2019
Last Updated
August 28, 2019
Record last verified: 2019-08