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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03216889
• Other study ID #: STUDY00140418
• Status: Completed
• Phase: N/A
• Start date: June 29, 2017
• Est. completion date: August 15, 2019

Study information

• Verified date: August 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 15, 2019
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Multiple Sclerosis
• Sclerosis
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Change from Baseline to Week 7
Secondary	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.	Change from Baseline to Week 7
Secondary	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.	Change from Baseline to Week 7
Secondary	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.	Change from Baseline to Week 7