The goal of this preliminary study is to determine the efficacy of an internet-based treatment program for insomnia for HIV-infected persons.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
SHUTi consists of six, 40-minute, weekly sessions during which the intervention components of stimulus control, sleep restriction, sleep hygiene, cognitive restructuring, and relapse prevention are delivered. Each SHUTi session has the same structure: the main content, a homework screen with options, and a summary of the main points.
Infectious Diseases Research Center
Indianapolis, Indiana, United States
Insomnia Severity Index
Change in the Insomnia Severity Index (ISI) score as measured by questionnaire. The ISI score ranges from 0 to 28 with higher scores indicating greater severity in insomnia symptoms.
Time frame: 10 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.