Status:
COMPLETED
HIV-related Insomnia and Inflammation
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Hiv
Insomnia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
The primary objective of this pilot trial is to evaluate the effects of cognitive behavioral therapy for insomnia (CBT-I) on changes in circulating levels of hsCRP at 24 weeks in virologically-suppres...
Eligibility Criteria
Inclusion
- HIV-1 infection, documented as listed clinically in the participant's electronic medical record by any of the following tests: (1) any licensed rapid HIV test, (2) HIV enzyme test kit at any time prior to study entry, (3) at least one detectable HIV-1 antigen, or (4) at least one detectable plasma HIV-1 RNA viral load.
- Age equal to or greater than 18 years.
- Ongoing receipt of stable antiretroviral therapy of any kind for at least 180 days prior to the date of the HIV-1 RNA value determining eligibility.
- HIV-1 RNA level \< 75 copies/mL at Screening.
- NOTE: There are no CD4 cell count eligibility criteria for this trial.
- ISI score ≥ 11 at Screening.
- NOTE: Use of sleeping aids/medications is permitted as long as the ISI score criterion is met.
Exclusion
- Inability to complete written, informed consent.
- Incarceration at the time of any study visit.
- Active suicidality at Entry, as determined by the patient's HIV provider or social worker following a positive response (1, 2, or 3) to PHQ-9 Item #9 and a positive response (yes) to one or more of the three questions (for Question #3, the previous attempt must be within the past 10 years) on the Patient Suicidality Form (see Appendix).
- Diagnosed disease or process, besides HIV infection, associated with increased systemic inflammation (including, but not limited to, systemic lupus erythematosus, inflammatory bowel diseases, or other collagen vascular diseases).
- NOTE: Hepatitis B or C co-infections are NOT exclusionary, but treatment for hepatitis C cannot be provided during study participation.
- End stage renal disease requiring renal replacement therapy (dialysis, transplantation).
- Known or suspected malignancy requiring systemic treatment within 180 days of the Entry Visit.
- NOTE: Localized treatment for skin cancers is not exclusionary.
- Therapy for serious medical illnesses within 14 days prior to the Entry Visit.
- NOTE: Therapy for serious medical illnesses that overlaps with a study visit will result in postponement of that study visit until the course of therapy is completed; postponement outside of the allowed study visit timeframe will result in study discontinuation.
- Pregnancy or breastfeeding during the course of the study.
- Receipt of investigational agents, cytotoxic chemotherapy, systemic immunosuppressive therapies, systemic glucocorticoids (of any dose), or anabolic steroids at the Entry Visit.
- NOTE: Physiologic testosterone replacement therapy or topical steroids is not exclusionary. Inhaled/nasal steroids are not exclusionary as long as the participant is not also receiving HIV protease inhibitors.
- Active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
- History of bipolar disorder or a psychotic disorder, including schizophrenia.
- NOTE: Depressive disorders are not exclusionary.
- Current sleep disorder diagnosis other than insomnia disorder (e.g., sleep apnea).
- Have a schedule requiring a bedtime earlier than 8:00pm or later than 2:00am or arising time earlier than 4:00am or later than 10:00am (thus preventing adoption of SHUTi interventions).
Key Trial Info
Start Date :
December 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04721067
Start Date
December 2 2021
End Date
March 15 2024
Last Update
May 29 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Indiana University Infectious Diseases Research
Indianapolis, Indiana, United States, 46202