HIV-related Insomnia and Inflammation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CBT-I This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population. |
Device: SHUTi
SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.
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| Active Comparator: Sleep Education/Hygiene This arm will receive best practices education on sleep hygiene. |
Behavioral: Sleep Education/Hygiene
A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services.
|
Outcome Measures
Primary Outcome Measures
- Change in hsCRP levels at 24 weeks [Baseline and 24 weeks]
Circulating high sensitivity C-reactive protein levels will be measured
Secondary Outcome Measures
- Change is IL-6 levels at 12 and 24 weeks [Baseline, 12 and 24 weeks]
Circulating interleukin-6 levels will be measured
- Change is sCD14 levels at 12 and 24 weeks [Baseline, 12 and 24 weeks]
Circulating soluble CD14 levels will be measured
- Change in sCD163 levels at 12 and 24 weeks [Baseline,12 and 24 weeks]
Circulating soluble CD163 levels will be measured
- Change in CD14+CD16+ monocytes at 12 and 24 weeks [Baseline,12 and 24 weeks]
Circulating intermediate monocytes as defined by flow cytometric evaluation for CD14+CD16+ monocytes will be measured
- Change in hsCRP levels at 12 weeks [Baseline and 12 weeks]
Circulating high sensitivity C-reactive protein levels will be measured
- Change in Insomnia Severity Index (ISI) at 12 and 24 weeks [Baseline, 12, and 24 weeks]
ISI questionnaire scores will be measured
- Change in Pittsburgh Sleep Quality Index (PSQI) at 12 and 24 weeks [Baseline, 12, and 24 weeks]
PSQI questionnaire scores will be measured
- Change in Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) at 12 and 24 weeks [Baseline, 12, and 24 weeks]
DBAS-16 questionnaire scores will be measured
- Change in Patient Health Questionnaire-9 (PHQ-9) at 12 and 24 weeks [Baseline, 12, and 24 weeks]
PHQ-9 questionnaire scores will be measured
- Change in Hopkins Symptom Checklist (SCL-20) at 12 and 24 weeks [Baseline, 12, and 24 weeks]
SCL-20 questionnaire scores will be measured
- Change in Generalized Anxiety Disorder-7 (GAD-7) at 12 and 24 weeks [Baseline, 12, and 24 weeks]
GAD-7 questionnaire scores will be measured
- Change in PROMIS Fatigue Short Form at 12 and 24 weeks [Baseline, 12, and 24 weeks]
PROMIS questionnaire scores will be measured
- Change in Alcohol Use Disorders Identification Test (AUDIT) at 12 and 24 weeks [Baseline, 12, and 24 weeks]
AUDIT questionnaire scores will be measured
- Change in Short Form-36 (SF-36) Health Survey at 12 and 24 weeks [Baseline, 12, and 24 weeks]
SF-36 questionnaire scores will be measured
- Change in sleep medication use at 12 and 24 weeks [Baseline, 12, and 24 weeks]
Concomitant medications for sleep will be recorded
- Change in insomnia treatment satisfaction at 12 and 24 weeks [Baseline, 12, and 24 weeks]
Insomnia treatment satisfaction scores will be measured
Eligibility Criteria
Criteria
Inclusion Criteria:
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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) at least one detectable HIV-1 antigen or at least one detectable plasma HIV-1 RNA viral load.
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Age equal to or greater than 18 years.
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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.
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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:
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Inability to complete written, informed consent.
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Incarceration at the time of any study visit.
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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).
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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.
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End stage renal disease requiring renal replacement therapy (dialysis, transplantation).
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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.
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Pregnancy or breastfeeding during the course of the study.
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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.
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Active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
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History of bipolar disorder or a psychotic disorder, including schizophrenia.
NOTE: Depressive disorders are not exclusionary.
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Current sleep disorder diagnosis other than insomnia disorder (e.g., sleep apnea).
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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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Indiana University Infectious Diseases Research | Indianapolis | Indiana | United States | 46202 |
Sponsors and Collaborators
- Indiana University
Investigators
- Principal Investigator: Samir K Gupta, MD, Indiana University School of Medicine
Study Documents (Full-Text)
More Information
Publications
None provided.- 1R21MH127206-01