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Clinical Trial Summary

The goal of this preliminary study is to determine the efficacy of an internet-based treatment program for insomnia for HIV-infected persons.


Clinical Trial Description

The primary objective of this pilot trial is to compare 10-week changes in Insomnia Severity Index (ISI) scores in HIV-infected adults with clinically relevant insomnia severity and who are already receiving virologically suppressive antiretroviral therapy (ART) and are then randomized to either treatment with the SHUTi cognitive behavioral therapy program or to Usual Care (UC). A total of 100 persons with HIV may be screened to identify the 32 participants to be enrolled and randomized into the pilot trial. These participants will be ≥ 18 years old, have been receiving antiretroviral therapy with an HIV viral load < 75 copies/mL within three months of the Entry Visit, and have an ISI score ≥ 15 within three months of the Entry Visit. These participants will be randomized 1:1 (stratified by age <40 vs. ≥ 40 years) to either insomnia treatment with the SHUTi cognitive behavioral therapy program (N=16) or usual care (N=16). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03390114
Study type Interventional
Source Indiana University
Contact
Status Completed
Phase N/A
Start date May 1, 2018
Completion date December 31, 2019

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