Skip to main content
OpenTrials
Completed

NCT Number: NCT04721067

HIV-related Insomnia and Inflammation

This randomized trial will determine the effects of internet cognitive behavioral therapy on measures of systemic inflammation in HIV-positive people receiving antiretroviral therapy.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Dyssomnias Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Insomnia Lentivirus Infections Mental Disorders Nervous System Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Infectious Diseases Research

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

SHUTi

Device

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.

Sleep Education/Hygiene

Behavioral

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.

Primary outcomes

  1. 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

  1. Change in IL-6 Levels at 24 Weeks

    Time frame: Baseline and 24 weeks

    Circulating interleukin-6 levels will be measured. Interleukin-6 is a measure of systemic inflammation.

  2. Change is sCD14 Levels at 24 Weeks

    Time frame: Baseline and 24 weeks

    Circulating soluble CD14 levels will be measured. Soluble CD14 is a measure of monocyte activation.

  3. Change in sCD163 Levels at 24 Weeks

    Time frame: Baseline and 24 weeks

    Circulating soluble CD163 levels will be measured. Soluble CD163 is a measure of monocyte/macrophage activation.

  4. Change in CD14+CD16+ Monocytes at 24 Weeks

    Time frame: Baseline and 24 weeks

    Circulating intermediate monocytes as defined by flow cytometric evaluation for CD14+CD16+ monocytes will be measured. CD14+CD16+ monocytes are measured by flow cytometry and indicate the pro-inflammatory subpopulation of monocytes.

  5. Change in hsCRP Levels at 12 Weeks

    Time frame: Baseline and 12 weeks

    Circulating high sensitivity C-reactive protein (hsCRP) levels will be measured. hsCRP is a measure of systemic inflammation.

  6. Change in Insomnia Severity Index (ISI) at 24 Weeks

    Time frame: Baseline and 24 weeks

    The Insomnia Severity Index (ISI) total score will be measured. The total scale has a minimum score of 0 and a maximum score of 28, with higher scores indicating a worse outcome.

  7. Change in Pittsburgh Sleep Quality Index (PSQI) at 24 Weeks

    Time frame: Baseline and 24 weeks

    Changes in the Pittsburgh Sleep Quality Index (PSQI) questionnaire global scores will be measured. The global PSQI score has a range from 0 to 21, with higher numbers indicating worse sleep quality.

  8. Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 24 Weeks

    Time frame: Baseline and 24 weeks

    The Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) questionnaire total scores will be measured. The DBAS-16 total score ranges from 0 to 10, with higher scores indicating more dysfunctional beliefs and attitudes about sleep.

  9. Change in Patient Health Questionnaire-9 (PHQ-9) at 24 Weeks

    Time frame: Baseline and 24 weeks

    Patient Health Questionnaire (PHQ-9) scores will be measured. The PHQ-9 ranges from 0 to 27, with higher scores indicating worse depression symptom severity.

  10. Change in Hopkins Symptom Checklist (SCL-20) at 24 Weeks

    Time frame: Baseline and 24 weeks

    The Hopkins Symptom Checklist (SCL-20) questionnaire score will be measured. The SCL-20 questionnaire scores range from 0 to 4, where higher scores indicate more severe depressive symptoms.

  11. Change in Generalized Anxiety Disorder-7 (GAD-7) at 24 Weeks

    Time frame: Baseline and 24 weeks

    The Generalized Anxiety Disorder-7 (GAD-7) questionnaire total score will be measured. The GAD-7 total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.

  12. Change in PROMIS FACIT-F Fatigue Short Form at 24 Weeks

    Time frame: Baseline and 24 weeks

    The Patient-Reported Outcomes Measurement Information System (PROMIS) Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) subscale questionnaire score ranges from 0 to 52, with higher scores indicating greater fatigue.

  13. Change in Alcohol Use Disorders Identification Test (AUDIT) at 24 Weeks

    Time frame: Baseline and 24 weeks

    Alcohol Use Disorders Identification Test (AUDIT) questionnaire total scores will be measured. The AUDIT total score ranges from 0 to 40, with higher scores indicating greater likelihood of alcohol dependence.

  14. Change in Short Form-36 (SF-36) Health Survey and 24 Weeks

    Time frame: Baseline and 24 weeks

    Short Form-36 (SF-36) general health total questionnaire scores will be measured. The SF-36 general health total score ranges from 0 to 100, with higher scores indicating better general health.

  15. Use of Sleep Medications at Week 12

    Time frame: Week 12

    The number of sleep medications used by each participant at Week 12

  16. Use of Sleep Medications at Week 24

    Time frame: Week 24

    The number of sleep medications used by each participant at Week 24

  17. Insomnia Treatment Satisfaction at Week 12

    Time frame: Week 12

    An assessment of the participant's satisfaction with their assigned insomnia treatment at Week 12, ranging from 1-5, with lower scores indicating greater overall treatment satisfaction.

  18. Insomnia Treatment Satisfaction at Week 24

    Time frame: Week 24

    An assessment of the participant's satisfaction with their assigned insomnia treatment at Week 24, ranging from 1-5, with lower scores indicating greater overall treatment satisfaction.

  19. Change in Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks

    Time frame: Baseline and 12 weeks

    Changes in the Pittsburgh Sleep Quality Index (PSQI) questionnaire global scores will be measured. The global PSQI score has a range from 0 to 21, with higher numbers indicating worse sleep quality.

  20. Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 12 Weeks

    Time frame: Baseline and 12 weeks

    The Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) questionnaire total scores will be measured. The DBAS-16 total score ranges from 0 to 10, with higher scores indicating more dysfunctional beliefs and attitudes about sleep.

  21. Change in Patient Health Questionnaire-9 (PHQ-9) at 12 Weeks

    Time frame: Baseline and 12 weeks

    Patient Health Questionnaire (PHQ-9) scores will be measured. The PHQ-9 ranges from 0 to 27, with higher scores indicating worse depression symptom severity.

  22. Change in Hopkins Symptom Checklist (SCL-20) at 12 Weeks

    Time frame: Baseline and 12 weeks

    The Hopkins Symptom Checklist (SCL-20) questionnaire score will be measured. The SCL-20 questionnaire scores range from 0 to 4, where higher scores indicate more severe depressive symptoms.

  23. Change in Generalized Anxiety Disorder-7 (GAD-7) at 12 Weeks

    Time frame: Baseline and 12 weeks

    The Generalized Anxiety Disorder-7 (GAD-7) questionnaire total score will be measured. The GAD-7 total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.

  24. Change in PROMIS FACIT-F Fatigue Short Form at 12 Weeks

    Time frame: Baseline and 12 weeks

    The Patient-Reported Outcomes Measurement Information System (PROMIS) Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) subscale questionnaire score ranges from 0 to 52, with higher scores indicating greater fatigue.

  25. Change in Alcohol Use Disorders Identification Test (AUDIT) at 12 Weeks

    Time frame: Baseline and 12 weeks

    Alcohol Use Disorders Identification Test (AUDIT) questionnaire total scores will be measured. The AUDIT total score ranges from 0 to 40, with higher scores indicating greater likelihood of alcohol dependence.

  26. Change in Short Form-36 (SF-36) Health Survey and 12 Weeks

    Time frame: Baseline and 12 weeks

    Short Form-36 (SF-36) general health total questionnaire scores will be measured. The SF-36 general health total score ranges from 0 to 100, with higher scores indicating better general health.

  27. Change in IL-6 Levels at 12 Weeks

    Time frame: Baseline and 12 weeks

    Circulating interleukin-6 levels will be measured. Interleukin-6 is a measure of systemic inflammation.

  28. Change is sCD14 Levels at 12 Weeks

    Time frame: Baseline and 12 weeks

    Circulating soluble CD14 levels will be measured. Soluble CD14 is a measure of monocyte activation.

  29. Change in sCD163 Levels at 12 Weeks

    Time frame: Baseline and 12 weeks

    Circulating soluble CD163 levels will be measured. Soluble CD163 is a measure of monocyte/macrophage activation.

  30. Change in CD14+CD16+ Monocytes at 12 Weeks

    Time frame: Baseline and 12 weeks

    Circulating intermediate monocytes as defined by flow cytometric evaluation for CD14+CD16+ monocytes will be measured. CD14+CD16+ monocytes are measured by flow cytometry and indicate the pro-inflammatory subpopulation of monocytes.

  31. Change in Insomnia Severity Index (ISI) at 12 Weeks

    Time frame: Baseline and 12 weeks

    The Insomnia Severity Index (ISI) total score will be measured. The total scale has a minimum score of 0 and a maximum score of 28, with higher scores indicating a worse outcome.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Treating Insomnia to Reduce Inflammation in HIV

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 22, 2021
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.