CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
SHUTi +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04721067
NCT04721067N/ACompleted

Treating Insomnia to Reduce Inflammation in HIV

Indiana University·interventional·Posted Jan 22, 2021·Updated May 29, 2025

In Brief

A clinical study evaluating SHUTi and Sleep Education/Hygiene for Hiv and Insomnia. Completed, enrolled 30 participants across 1 site.

Detailed Summary

This randomized trial will determine the effects of internet cognitive behavioral therapy on measures of systemic inflammation in HIV-positive people receiving antiretroviral therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHiv, Insomnia
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJan 22, 2021
Enrollment StartDec 2, 2021
Primary CompletionMar 15, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.4 years ago

Interventions

SHUTidevice

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.

Sleep Education/Hygienebehavioral

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.