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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy for insomnia
Cognitive behavioral therapy for insomnia + biweekly support
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Catherine Siengsukon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

cognitive behavioral therapy for insomnia (CBT-I)

CBT-I + biweekly support

Arm Description

Participants randomized to this arm will participate in a 6-week web-based cognitive behavioral therapy for insomnia (CBT-I) program.

Participants randomized to this arm will participate in a 6-week web-based CBT-I program. In addition, biweekly support consisting of one-on-one, semi-structured, online video-chat sessions (via HIPAA-compliant Zoom) or phone calls will be conducted every other week.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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.
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.

Full Information

First Posted
October 1, 2018
Last Updated
August 26, 2019
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03783585
Brief Title
Feasibility of Web-based CBT-I Intervention in Individuals With Multiple Sclerosis
Official Title
Assessment of the Feasibility of a Web-based CBT-I Intervention to Improve Sleep Quality and Fatigue in Individuals With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
August 20, 2019 (Actual)
Study Completion Date
August 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cognitive behavioral therapy for insomnia (CBT-I)
Arm Type
Experimental
Arm Description
Participants randomized to this arm will participate in a 6-week web-based cognitive behavioral therapy for insomnia (CBT-I) program.
Arm Title
CBT-I + biweekly support
Arm Type
Experimental
Arm Description
Participants randomized to this arm will participate in a 6-week web-based CBT-I program. In addition, biweekly support consisting of one-on-one, semi-structured, online video-chat sessions (via HIPAA-compliant Zoom) or phone calls will be conducted every other week.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy for insomnia
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy for insomnia + biweekly support
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in Insomnia Severity Index (ISI)
Description
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
Time Frame
baseline and week 8
Secondary Outcome Measure Information:
Title
change in Pittsburgh Sleep Quality Index (PSQI)
Description
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
Time Frame
baseline and week 8
Title
change in Modified Fatigue Impact Scale (MFIS)
Description
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
baseline and week 8
Title
change in Fatigue Severity Scale (FSS)
Description
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.
Time Frame
baseline and week 8
Title
change in Multiple Sclerosis Impact Scale (MSIS)
Description
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
baseline and week 8

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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Siengsukon, PT, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catherine Siengsukon
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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

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