Clinical Trials Directory

Trials / Completed

CompletedNCT03783585

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
44 (actual)
Sponsor
University of Kansas Medical Center · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCognitive behavioral therapy for insomniaThe 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.
BEHAVIORALCognitive behavioral therapy for insomnia + biweekly supportIndividuals 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.

Timeline

Start date
2018-10-01
Primary completion
2019-08-20
Completion
2019-08-20
First posted
2018-12-21
Last updated
2019-08-28

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03783585. Inclusion in this directory is not an endorsement.