HIV-related Insomnia and Inflammation

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 2, 2021

Primary Completion Date

March 15, 2024

Study Completion Date

March 15, 2024

Conditions
HivInsomnia
Interventions
DEVICE

SHUTi

SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.

BEHAVIORAL

Sleep Education/Hygiene

A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services.

Trial Locations (1)

46202

Indiana University Infectious Diseases Research, Indianapolis

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Indiana University

OTHER

NCT04721067 - HIV-related Insomnia and Inflammation | Biotech Hunter | Biotech Hunter