Back to resultsCognitive Behavioral Therapy for Insomnia to Address Insomnia Symptoms in People With Multiple Sclerosis
Primary Purpose
Insomnia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Insomnia
Control
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Multiple Sclerosis
Eligibility Criteria
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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Control
Arm Description
6 weeks of CBT-I.
6 weeks of stretching and thinking games.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pittsburgh Sleep Quality Index (PSQI)
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.
Modified Fatigue Impact Scale (MFIS)
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.
Fatigue Severity Scale (FSS)
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.
Multiple Sclerosis Impact Scale (MSIS)
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.
Full Information
NCT ID
NCT03216889
First Posted
July 11, 2017
Last Updated
August 26, 2019
Sponsor
University of Kansas Medical Center
Collaborators
National Multiple Sclerosis Society
1. Study Identification
Unique Protocol Identification Number
NCT03216889
Brief Title
Cognitive Behavioral Therapy for Insomnia to Address Insomnia Symptoms in People With Multiple Sclerosis
Official Title
Cognitive Behavioral Therapy for Insomnia to Address Insomnia Symptoms in People With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 29, 2017 (Actual)
Primary Completion Date
August 15, 2019 (Actual)
Study Completion Date
August 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
National Multiple Sclerosis Society
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Arm Type
Experimental
Arm Description
6 weeks of CBT-I.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
6 weeks of stretching and thinking games.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia
Intervention Description
Involves attending 1 hour long sessions weekly for 6 weeks. Sessions will be one-on-one or in a group.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Involves attending 1 hour long sessions weekly for 6 weeks. Sessions will involve stretching and thinking games.
Primary Outcome Measure Information:
Title
Insomnia Severity Index (ISI)
Description
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.
Time Frame
Change from Baseline to Week 7
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
Change from Baseline to Week 7
Title
Modified Fatigue Impact Scale (MFIS)
Description
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.
Time Frame
Change from Baseline to Week 7
Title
Fatigue Severity Scale (FSS)
Description
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.
Time Frame
Change from Baseline to Week 7
Title
Multiple Sclerosis Impact Scale (MSIS)
Description
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.
Time Frame
Change from Baseline to Week 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katie Siengsukon, PT, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
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Cognitive Behavioral Therapy for Insomnia to Address Insomnia Symptoms in People With Multiple Sclerosis
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