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

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ClinicalTrials.gov Identifier: NCT03783585
Recruitment Status : Recruiting
First Posted : December 21, 2018
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Catherine Siengsukon, PT, PhD, University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Cognitive behavioral therapy for insomnia Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of the Feasibility of a Web-based CBT-I Intervention to Improve Sleep Quality and Fatigue in Individuals With Multiple Sclerosis
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


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

Experimental: CBT-I + biweekly support
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.
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




Primary Outcome Measures :
  1. change in Insomnia Severity Index (ISI) [ Time Frame: baseline and week 8 ]
    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 :
  1. change in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: baseline and week 8 ]
    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

  2. change in Modified Fatigue Impact Scale (MFIS) [ Time Frame: baseline and week 8 ]
    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.

  3. change in Fatigue Severity Scale (FSS) [ Time Frame: baseline and week 8 ]
    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.

  4. change in Multiple Sclerosis Impact Scale (MSIS) [ Time Frame: baseline and week 8 ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783585


Contacts
Contact: Catherine Siengsukon, PT, PhD 9135880601 csiengsukon@kumc.edu

Locations
United States, Kansas
Catherine Siengsukon Recruiting
Kansas City, Kansas, United States, 66160
Contact: Catherine Siengsukon    913-588-6913    csiengsukon@kumc.edu   
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
Principal Investigator: Catherine Siengsukon, PT, PhD University of Kansas Medical Center

Responsible Party: Catherine Siengsukon, PT, PhD, Associate Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03783585     History of Changes
Other Study ID Numbers: STUDY00142464
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases