Internet-Based Cognitive Behavioral Therapy to Treat Insomnia in HIV: A Pilot Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- HIV/AIDS
- Sponsor
- Indiana University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Insomnia Severity Index
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The goal of this preliminary study is to determine the efficacy of an internet-based treatment program for insomnia for HIV-infected persons.
Detailed 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).
Investigators
Samir K Gupta, MD, MS
Professor of Medicine
Indiana University
Eligibility Criteria
Inclusion Criteria
- •HIV-1 infection, documented by both: (1) any licensed rapid HIV test or HIV enzyme test kit at any time prior to study entry and (2) by at least one detectable HIV-1 antigen or at least one detectable plasma HIV-1 RNA viral load.
- •Age equal to or greater than 18 years.
- •Ongoing receipt of antiretroviral therapy of any kind for at least 3 months prior to the Entry Visit.
- •HIV-1 RNA level \< 75 copies/mL obtained during routine clinical care within 90 days of the Entry Visit.
- •NOTE: There are no CD4 cell count eligibility criteria for this trial.
- •ISI score ≥ 15
Exclusion Criteria
- •Inability to complete written, informed consent.
- •Incarceration at the time of any study visit.
- •Active suicidality, as determined by the patient's HIV provider or social worker following a positive response (1, 2, or 3) to PHQ-9 Item #9
- •Diagnosed vascular disease (documented history of angina pectoris, coronary disease, peripheral vascular disease, cerebrovascular disease, aortic aneurysm, or otherwise known atherosclerotic disease).
- •History of congestive heart failure, even if currently compensated.
- •Diagnosed disease or process, besides HIV infection, associated with increased systemic inflammation (including, but not limited to, systemic lupus erythematosis, inflammatory bowel diseases, other collagen vascular diseases).
- •Note: Hepatitis B or C co-infections are NOT exclusionary
- •Known or suspected malignancy requiring systemic treatment within 180 days of the Entry Visit.
- •NOTE: Localized treatment for skin cancers is not exclusionary.
- •Uncontrolled hyperthyroidism or hypothyroidism, defined as TSH values outside of the local reference range on most recent clinical assessment.
Outcomes
Primary Outcomes
Insomnia Severity Index
Time Frame: 10 weeks
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.