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

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: Control; Behavioral: Cognitive Behavioral Therapy for Insomnia

• Registration Number: NCT03216889
• Lead Sponsor: University of Kansas Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-29
• Study First Submitted: 2017-07-11
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-13
• Status Verified: 2019-08
• Primary Completion: 2019-08-15
• Study Completion: 2019-08-15
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	6 weeks of stretching and thinking games.
Cognitive Behavioral Therapy for Insomnia (CBT-I)	Cognitive Behavioral Therapy for Insomnia	6 weeks of CBT-I.

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI)	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 Outcome Measures

Name	Time	Method
Fatigue Severity Scale (FSS)	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.
Pittsburgh Sleep Quality Index (PSQI)	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.
Modified Fatigue Impact Scale (MFIS)	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.
Multiple Sclerosis Impact Scale (MSIS)	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.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States