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Clinical Trials/NCT04721067
NCT04721067CompletedNot Applicable

Treating Insomnia to Reduce Inflammation in HIV

Indiana University2 sites in 1 country30 target enrollmentStarted: December 2, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Change in hsCRP Levels at 24 Weeks
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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-suppressed, HIV-positive adults with insomnia, defined as having an Insomnia Severity Index (ISI) score ≥ 11. Secondary objectives include comparing changes in hsCRP at 12 weeks, changes in other circulating inflammation biomarkers (IL-6, sCD14, sCD163, CD14+CD16+ monocytes) at both 12 and 24 weeks, and ISI scores and other self-reported patient outcomes at both 12 and 24 weeks.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

The study outcomes will be analyzed and compared by blinded investigators and statisticians.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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 Criteria

  • •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).

Outcomes

Primary Outcomes

Change in hsCRP Levels at 24 Weeks

Time Frame: Baseline and 24 weeks

Circulating high sensitivity C-reactive protein levels will be measured

Secondary Outcomes

  • Change in IL-6 Levels at 24 Weeks(Baseline and 24 weeks)
  • Change is sCD14 Levels at 24 Weeks(Baseline and 24 weeks)
  • Change in sCD163 Levels at 24 Weeks(Baseline and 24 weeks)
  • Use of Sleep Medications at Week 12(Week 12)
  • Use of Sleep Medications at Week 24(Week 24)
  • Change in CD14+CD16+ Monocytes at 24 Weeks(Baseline and 24 weeks)
  • Change in hsCRP Levels at 12 Weeks(Baseline and 12 weeks)
  • Change in Insomnia Severity Index (ISI) at 24 Weeks(Baseline and 24 weeks)
  • Change in Pittsburgh Sleep Quality Index (PSQI) at 24 Weeks(Baseline and 24 weeks)
  • Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 24 Weeks(Baseline and 24 weeks)
  • Change in Patient Health Questionnaire-9 (PHQ-9) at 24 Weeks(Baseline and 24 weeks)
  • Change in Hopkins Symptom Checklist (SCL-20) at 24 Weeks(Baseline and 24 weeks)
  • Change in Generalized Anxiety Disorder-7 (GAD-7) at 24 Weeks(Baseline and 24 weeks)
  • Change in PROMIS FACIT-F Fatigue Short Form at 24 Weeks(Baseline and 24 weeks)
  • Change in Alcohol Use Disorders Identification Test (AUDIT) at 24 Weeks(Baseline and 24 weeks)
  • Change in Short Form-36 (SF-36) Health Survey and 24 Weeks(Baseline and 24 weeks)
  • Insomnia Treatment Satisfaction at Week 12(Week 12)
  • Insomnia Treatment Satisfaction at Week 24(Week 24)
  • Change in Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks(Baseline and 12 weeks)
  • Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 12 Weeks(Baseline and 12 weeks)
  • Change in Patient Health Questionnaire-9 (PHQ-9) at 12 Weeks(Baseline and 12 weeks)
  • Change in Hopkins Symptom Checklist (SCL-20) at 12 Weeks(Baseline and 12 weeks)
  • Change in Generalized Anxiety Disorder-7 (GAD-7) at 12 Weeks(Baseline and 12 weeks)
  • Change in PROMIS FACIT-F Fatigue Short Form at 12 Weeks(Baseline and 12 weeks)
  • Change in Alcohol Use Disorders Identification Test (AUDIT) at 12 Weeks(Baseline and 12 weeks)
  • Change in Short Form-36 (SF-36) Health Survey and 12 Weeks(Baseline and 12 weeks)
  • Change in IL-6 Levels at 12 Weeks(Baseline and 12 weeks)
  • Change is sCD14 Levels at 12 Weeks(Baseline and 12 weeks)
  • Change in sCD163 Levels at 12 Weeks(Baseline and 12 weeks)
  • Change in CD14+CD16+ Monocytes at 12 Weeks(Baseline and 12 weeks)
  • Change in Insomnia Severity Index (ISI) at 12 Weeks(Baseline and 12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Samir K. Gupta, MD

Professor of Medicine

Indiana University

Study Sites (2)

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