Cognitive Behavioral Therapy to Treat Insomnia in Persons With HIV Infection

Completed · Not applicable

Conditions studied: HIV/AIDS, Insomnia

In brief

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

Key facts

Study ID

NCT03390114

Run by

Indiana University

People needed

20

Starts

2018-05-01

Expected to finish

2019-12-31

Last updated by the study team

2021-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Infectious Diseases Research Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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