NCT04721067已完成不适用
Treating Insomnia to Reduce Inflammation in HIV
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in hsCRP Levels at 24 Weeks
研究概览
简要总结
This randomized trial will determine the effects of internet cognitive behavioral therapy on measures of systemic inflammation in HIV-positive people receiving antiretroviral therapy.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study outcomes will be analyzed and compared by blinded investigators and statisticians.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Change in hsCRP Levels at 24 Weeks
时间窗: Baseline and 24 weeks
Circulating high sensitivity C-reactive protein levels will be measured
次要结局
- 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)
研究者
Samir K. Gupta, MD
Professor of Medicine
Indiana University
研究点 (2)
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