Feasibility of Web-based CBT-I Intervention in Individuals With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Assessment of the Feasibility of a Web-based CBT-I Intervention to Improve Sleep Quality and Fatigue in Individuals With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03783585
• Other study ID #: STUDY00142464
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: August 20, 2019

Study information

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

Clinical Trial Summary

Forty individuals with multiple sclerosis (MS) will be randomly assigned to a 6-week web-based cognitive behavior therapy for insomnia intervention (wCBT-I) or to wCBT-I plus biweekly support meetings with research personnel via phone or video. Questionnaires will be used to assess sleep quality, fatigue, and satisfaction. Recruitment, retention, attrition, adherence, and safety information will also be collected. This study is significant because addressing insomnia symptoms through CBT-I could be a low-cost, low-risk, non-pharmacological options for improving sleep quality and MS symptoms in individuals with MS. This study is innovative because CBT-I has never been delivered via a web-based application to individuals with MS which may increase access to services.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 20, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18-80 years old

• 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 (ISI)

• English speaking

• reports access to internet service and phone

• has a high school diploma to serve as a proxy measurement of reading ability to ensure adequate reading ability to participate in the study.

Exclusion Criteria:

• known untreated sleep disorder (such as sleep apnea or restless leg syndrome)

• >3 on STOP BANG indicating risk of sleep apnea

• increased risk of restless leg syndrome

• nervous system disorder other than MS

• relapse and/or corticosteroid use in past 8 weeks

• score of =15 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorse any suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)

• performs shift-work.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Cognitive behavioral therapy for insomnia
The web-based CBT-I program is a 6-week interactive, online program that delivers typical CBT-I treatment techniques of stimulus control, sleep restriction, behavioral modifications, and cognitive restructuring.
• Cognitive behavioral therapy for insomnia + biweekly support
Individuals randomized into the CBT-I + biweekly support will participate in CBT-I as described as well as a biweekly phone call or video call with research personnel for motivational interviewing.

Locations

Country	Name	City	State
United States	Catherine Siengsukon	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Insomnia Severity Index (ISI)	The ISI is a valid and reliable measure of sleep difficulties and consists of 7 questions each rated on a 0-4 scale. The range of scores on the ISI is 0-28, with =10 suggesting clinical insomnia	baseline and week 8
Secondary	change in Pittsburgh Sleep Quality Index (PSQI)	The PSQI is a well-validated and reliable measure of sleep quality and 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	baseline and week 8
Secondary	change in Modified Fatigue Impact Scale (MFIS)	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.	baseline and week 8
Secondary	change in Fatigue Severity Scale (FSS)	Fatigue Severity Scale (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.	baseline and week 8
Secondary	change in Multiple Sclerosis Impact Scale (MSIS)	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.	baseline and week 8