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

University of Kansas

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Cognitive behavioral therapy for insomnia; Behavioral: Cognitive behavioral therapy for insomnia + biweekly support

Study type: Interventional

Funder types: Other

Identifiers

NCT03783585

STUDY00142464

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

cognitive behavioral therapy for insomnia (CBT-I)

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive behavioral therapy for insomnia

CBT-I + biweekly support

Experimental group

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.

Treatment:

Behavioral: Cognitive behavioral therapy for insomnia + biweekly support

Behavioral: Cognitive behavioral therapy for insomnia