Stress Task for People With HIV

(HIV Stress Trial)

Overseen By Rachel Hart, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Hormonal birth control

Disqualifiers: Cocaine, Opioid use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how stress affects people with HIV, both with and without other conditions such as cannabis use disorder and depression. Participants will engage in two stress-related activities, including the Yale Pain Stress Task (YPST), to assess how stress influences their drug use and mood. The trial includes four groups: individuals with HIV, those with HIV plus other conditions, healthy individuals, and those without HIV but with other conditions. Eligible participants may include those who are HIV-positive with stable health or those with cannabis use disorder and depression but no HIV. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance stress management strategies for individuals with HIV and related conditions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those on medications that affect the HPA axis (a system that controls stress responses) and immune function. It's best to discuss your specific medications with the trial team.

What prior data suggests that the Yale Pain Stress Task (YPST) is safe for participants?

Research has shown that the Yale Pain Stress Task (YPST) is used to study responses to stress and pain. As it is neither a medication nor a device, it lacks a safety profile like those of drugs. Instead, safety concerns focus on how participants manage the stress task itself.

Studies have found that these tasks are generally well-tolerated. Participants might feel stressed or uncomfortable during the task, but these feelings usually subside quickly. No reports of long-term negative effects from the YPST have emerged in the reviewed sources.

The trial aims to understand stress and mood, so while the task might be challenging, it is not expected to cause harm. Prospective participants should discuss any concerns with the study team, who can provide more details on what to expect during the sessions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Yale Pain Stress Task (YPST) because it offers a novel approach to understanding stress responses in people with HIV. Unlike traditional treatments that focus on medication to alleviate HIV symptoms or manage stress, the YPST is a method designed to observe how stress impacts individuals with HIV, both with and without complex morbidities. This trial aims to reveal insights into the psychological and physiological stress reactions, which could lead to better stress management strategies and improved quality of life for those living with HIV. By comparing different groups, including healthy controls, this method could uncover unique stress pathways and responses, paving the way for personalized interventions.

What evidence suggests that the Yale Pain Stress Task (YPST) is effective for assessing drug use and mood symptoms in people with HIV?

Research has shown that stress significantly affects people living with HIV, impacting their immune system and overall health. In this trial, participants will undergo the Yale Pain Stress Task (YPST) to explore how stress influences pain and mood in individuals with various health conditions. Although YPST is not a treatment, it aids researchers in understanding stress's effects on the body. This knowledge may lead to better insights and potentially new methods for managing stress-related issues in people with HIV. Early findings suggest that understanding these stress patterns could be crucial for future treatments. ^{1 2 3 6 7}

Who Is on the Research Team?

Rajita Sinha, Ph.D.

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for people living with HIV who may also be dealing with depression, pain, stress, and cannabis use disorder. Participants will be divided into four groups based on their health conditions to take part in two sessions of a task designed to study pain and stress.

Inclusion Criteria

Additional criteria for PLWH: CB positive urine toxicology, meet DSM-5 criteria for CUD and MDD as assessed using SCID-I

Additional criteria for PLWH +CM: HIV-1 test negative, urine toxicology negative, no major medical and psychiatric diagnoses based on DSM-V

Additional criteria for CM Only: HIV-1 test negative, urine toxicology positive, meet DSM-5 criteria for CUD and MDD as assessed using SCID-I

Exclusion Criteria

Meet primary, current moderate and severe criteria for other SUD including cocaine, alcohol, opiates, sedatives, nicotine

Current use or past history of cocaine or opioid use disorder

History of any psychotic disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Sessions

Participants undergo 2 sessions of the Yale Pain Stress Task (YPST) to assess stress and pain responses

1 week

2 visits (in-person)

Follow-up

Participants are monitored for drug use and mood symptoms after the experimental sessions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Yale Pain Stress Task (YPST)

Trial Overview The Yale Pain Stress Task (YPST) is being tested to understand its effects on individuals with varying health issues including HIV, depression, and substance use. The study involves two sessions followed by an assessment phase for drug use and mood symptoms.

How Is the Trial Designed?

Group I: Healthy control (HC) Experimental Treatment 1 Intervention

Participants that are not HIV-positive and no complex morbidities will undergo 2 Within Subjects factors of Condition, Stress and No Stress (order of condition randomly assigned and counterbalanced)

Group II: HIV-positive and complex morbidity (PLWH/CM+) Experimental Treatment 1 Intervention

Participants that are HIV-positive with complex morbidities will undergo 2 Within Subjects factors of Condition, Stress and No Stress (order of condition randomly assigned and counterbalanced)

Group III: HIV-positive (PLWH+) Experimental Treatment 1 Intervention

Participants that are HIV-positive only will undergo 2 Within Subjects factors of Condition, Stress and No Stress (order of condition randomly assigned and counterbalanced)

Group IV: Control and complex morbidity (HC+CM) Experimental Treatment 1 Intervention

Participants that are not HIV-positive and have complex morbidities will undergo 2 Within Subjects factors of Condition, Stress and No Stress (order of condition randomly assigned and counterbalanced)

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The study found that acute pain, induced by the cold pressor test, affected immune responses and anxiety levels similarly in both HIV+ and HIV- adults, indicating that pain responses may not differ significantly based on HIV status.

Significant associations were observed between perceived pain intensity and various physiological measures, such as heart rate and immune cell counts, suggesting that pain perception can influence both psychological and immune responses in individuals, regardless of their HIV status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing a model: effects of pain on immunity in HIV+ and HIV- participants. Eller, LS.[2007]

In a study of 93 persons living with HIV/AIDS, pain-related anxiety was found to significantly correlate with increased symptoms of anxiety and depression, indicating that anxiety about pain can worsen mental health outcomes.

The study suggests that addressing pain-related anxiety may be important for improving the overall well-being of individuals with HIV/AIDS, as it affects their emotional distress beyond other factors like physical health and demographics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain-related anxiety in relation to anxiety and depression among persons living with HIV/AIDS. Brandt, CP., Zvolensky, MJ., Daumas, SD., et al.[2018]

Over 60% of the 438 ambulatory AIDS patients surveyed reported frequent or persistent pain, with an average pain intensity of 5.4 out of 10, indicating significant pain levels in this population.

The presence and intensity of pain were linked to more advanced HIV disease and were influenced by demographic factors such as gender and race, highlighting the need for targeted pain management strategies in AIDS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain in ambulatory AIDS patients. I: Pain characteristics and medical correlates. Breitbart, W., McDonald, MV., Rosenfeld, B., et al.[2022]

In a study of 254 adults living with HIV, better central nervous system (CNS) penetration of antiretroviral therapy (measured by the CNS Penetration-Effectiveness score) was not linked to reduced rates of chronic pain, indicating that CNS ARV penetration may not be a key factor in managing pain in these patients.

However, a higher CPE score was found to be an independent risk factor for depression, particularly associated with exposure to the drug zidovudine, suggesting that while pain management may not be directly influenced by ARV CNS penetration, mental health outcomes could be affected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Better Antiretroviral Central Nervous System Penetration is Not Associated with Reduced Chronic Pain in People Living with Human Immunodeficiency Virus. Robbins, NM., Chaiklang, K., Supparatpinyo, K.[2020]

In a study of 145 HIV-infected individuals with persistent pain, over half (53.8%) were diagnosed with PTSD, highlighting a strong link between trauma and mental health in this population.

Those with PTSD experienced significantly higher pain intensity and greater interference in daily activities, suggesting that addressing PTSD may be crucial for improving pain management and overall quality of life in HIV patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of PTSD on pain experience in persons with HIV/AIDS. Smith, MY., Egert, J., Winkel, G., et al.[2019]

HIV-positive patients experience significant brain abnormalities in areas related to pain processing, which correlate with higher pain scores, indicating that their pain responses may be abnormal compared to HIV-negative individuals.

Addressing both the physical and affective components of pain in HIV-positive patients could improve their overall quality of life, as lower pain scores are associated with better physical and mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Altered Associations between Pain Symptoms and Brain Morphometry in the Pain Matrix of HIV-Seropositive Individuals. Castillo, D., Ernst, T., Cunningham, E., et al.[2019]

This study will investigate the relationship between distress, inflammatory reactivity, and pain in 100 people with HIV over 6 months, aiming to understand how distress may exacerbate pain through inflammatory responses.

The research will specifically assess how inflammatory reactivity may mediate the connection between distress and pain, using various validated measures to capture these interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol: an observational study of distress, immune function and persistent pain in HIV. Madden, VJ., Msolo, N., Mqadi, L., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06784908

NCT06784908 | Stress and Pain in People Living With HIV Stress-immune Mechanisms for People Living With HIV, CUD and Depression ... Other : Yale Pain Stress Task (YPST). Individuals in the experimental cohort ...

2. withpower.com withpower.com/trial/stress-task-for-people-with-hiv-39a9a

Stress Task for People With HIV (HIV Stress Trial) ... Pain, HIV/AIDS, Pain, Depression, Cannabis Use Disorder and Stress. See ... Pain in People Living with Human Immunodeficiency Virus. [2020]. 6. United ...

3. yalemedicine.org yalemedicine.org/clinical-trials/stress-and-pain-in-people-living-with-hiv

Stress and Immune Effects in People with HIV This is a 6-week project to study the effects of stress on our biology, hormones and immune responses in people with HIV (PWH).

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06784908/stress-and-pain-in-people-living-with-hiv

Stress and Pain in People Living With HIV Treatment. Yale Pain Stress Task (YPST). Clinical Study ID ... immune function due to alterations in epigenetic mechanisms, and ...

5. ysph.yale.edu ysph.yale.edu/research/department-research/epidemiology-of-microbial-diseases/research-themes/disease-areas/hiv/

Disease Research - HIV | Yale School of Public Health HIV. HIV, the AIDS virus (yellow), infecting a human cell. Since the first diagnosis in the United States in 1982, the human immunodeficiency virus (HIV) has ...

6. medicine.yale.edu medicine.yale.edu/profile/rajita-sinha/

Rajita Sinha, PhD - Yale School of Medicine She is the founding director of the Yale Interdisciplinary Stress Center that focuses on understanding the neurobiology and psychology of stress, trauma and ...

7. reporter.nih.gov reporter.nih.gov/search/4l3zDWVp60GIlF20hjgcpw/project-details/10880361

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