Status:
COMPLETED
Cognitive Behavioral Therapy to Treat Insomnia in Persons With HIV Infection
Lead Sponsor:
Indiana University
Conditions:
HIV/AIDS
Insomnia
Eligibility:
All Genders
18+ years
Phase:
NA
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 re...
Eligibility Criteria
Inclusion
- 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
- 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.
- Last known clinic-based estimated glomerular filtration rate (eGFR) \< 50 mL/min/1.73m2. (calculated from the 2009 CKD-EPI equation).
- Uncontrolled diabetes defined as the last known clinic-based Hgb A1C \> 8.0 g/dL.
- Last known clinic-based total cholesterol \> 240 mg/dL.
- Therapy for serious medical illnesses within 14 days prior to screening.
- Note: Therapy for serious medical illnesses that overlaps with a main 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 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 schizophrenia, bipolar disorder, or dementia.
- NOTE: Depression is not exclusionary as long as the severity of depression does impede ability to perform the required study procedures.
- Musculoskeletal or neurologic disorders that impede ability to perform the required study procedures.
- History of sleep apnea or restless leg syndrome.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03390114
Start Date
May 1 2018
End Date
December 31 2019
Last Update
February 21 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Infectious Diseases Research Center
Indianapolis, Indiana, United States, 46202