Stress Testing for Heart Disease

(DASHH Trial)

Overseen By Margo Nathan, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Hormonal agents, Steroids, Antihistamines, others

Disqualifiers: Bipolar, Psychotic disorder, Diabetes, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Depression is a known risk factor for cardiovascular disease (CVD), and this comorbidity contributes significantly to the morbidity and mortality of women. The menopausal transition or perimenopause is a period of vulnerability for both depression and CVD, making it a key time to study this critical public health issue. This research will preliminarily explore whether disruption in two novel stress pathways 1) the renin-angiotensin-aldosterone system (RAAS) and autonomic nervous system (ANS) and their relationship may underlie the link between these illnesses. Findings will provide important insight into potential mechanisms by which depression during perimenopause may increase risk for CVD in midlife women, which will inform potential risk reduction and treatment strategies that can improve health outcomes in this population.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as hormonal agents, steroids, blood pressure medications, and antihistamines, for a specific period before participating. However, you can continue taking antidepressant medications if your dose has been stable for at least 30 days before the study.

Is the Trier Social Stress Test (TSST) safe for humans?

The Trier Social Stress Test (TSST) is widely used to study stress responses and has been adapted for various settings, including virtual and group formats. Studies have shown it can safely induce stress responses like changes in mood and heart rate, with no major safety concerns reported. ^{1 2 3 4 5}

How does the treatment in the Stress Testing for Heart Disease trial differ from other treatments for heart disease?

The treatment in this trial uses a virtual version of the Trier Social Stress Test (TSST) to induce stress and measure heart responses, which is unique because it can be conducted remotely, making it more accessible and standardized compared to traditional in-person stress tests. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Trier Social Stress Test (TSST) for heart disease?

The Trier Social Stress Test (TSST) has been shown to effectively induce stress responses, including changes in heart rate and blood pressure, which are relevant for studying heart disease. A remote version of the TSST was able to reliably evoke cardiovascular responses, making it a useful tool for assessing stress-related heart disease risk. ^{1 2 3 4 5}

Who Is on the Research Team?

Margo Nathan, MD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This study is for women aged 44-55 in late perimenopause, who may be on stable antidepressant medication. It's not for those with severe depression, current CVD or diabetes, recent use of certain blood pressure or steroid medications, active smoking or substance abuse, or hormonal treatments within the last month.

Inclusion Criteria

You have taken antihistamines in the last two weeks.

I am a woman aged 44-55 and am in the late stage of transitioning to menopause.

My antidepressant dose has been stable for the last 30 days.

Exclusion Criteria

I am taking or have recently taken medications that affect my RAAS.

I have taken blood pressure medication in the last 3 months.

You currently have a problem with drinking alcohol or using drugs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (remote)

Treatment

Participants undergo a social stress task (TSST) and physiological measurements are taken

1 day

1 visit (in-person)

Follow-up

Participants have a brief telephone call to review participation and answer questions

1 day

1 visit (telephone)

What Are the Treatments Tested in This Trial?

Interventions

• Trier Social Stress Test

Trial Overview The trial explores how stress affects heart health and depression during menopause by testing responses to the Trier Social Stress Test. It aims to understand if disruptions in stress pathways contribute to cardiovascular disease risk in midlife women.

How Is the Trial Designed?

Group I: Women without perimenopausal depression Experimental Treatment 1 Intervention

Participants will undergo a social stress task (TSST)

Group II: Women with perimenopausal depression Experimental Treatment 1 Intervention

Participants will undergo a social stress task (TSST)

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

The Foundation of Hope for Research and Treatment of Mental Illness

Collaborator

Trials

3

Recruited

50+

Published Research Related to This Trial

The study validated a remote version of the Trier Social Stress Test (TSST-Online) for children, demonstrating that it effectively activates the stress response similar to in-person assessments, with 63% of participants showing a significant increase in cortisol levels.

The TSST-Online allows for safe and effective assessment of stress reactivity in children and adolescents without the need for in-person visits, making it particularly useful during situations like the COVID-19 pandemic or for participants living far from research facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of an online version of the Trier Social Stress Test in a study of adolescents. Gunnar, MR., Reid, BM., Donzella, B., et al.[2023]

The Trier Social Stress Test in group format (TSST-G) effectively induces a psychobiological stress response, as shown by significant increases in negative affect, heart rate (HR), and salivary alpha-amylase (sAA) in a study with 294 participants during the first test.

When comparing two different protocols for the second test, the defensive speech protocol resulted in a stronger autonomic stress response (higher HR and lower heart rate variability) than a neutral presentation, indicating that ego-involving tasks may be more effective for studying stress reactivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mood and autonomic responses to repeated exposure to the Trier Social Stress Test for Groups (TSST-G). Boesch, M., Sefidan, S., Ehlert, U., et al.[2014]

The virtual version of the Trier Social Stress Test (TSST) effectively induced a significant acute stress response in 50 undergraduate students, as evidenced by increased cortisol levels and subjective stress reports.

This virtual approach may offer advantages such as reduced costs and greater accessibility for psychological experiments, while also revealing that individuals who recently experienced loss had a dampened cortisol response, aligning with previous research findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of a Virtual Trier Social Stress Test: Initial Findings and Benchmarking Comparisons. Fallon, MA., Careaga, JS., Sbarra, DA., et al.[2018]

The study utilized the Trier Social Stress Test (TSST) to analyze both non-verbal and verbal communication behaviors, identifying 51 distinct behavioral sequences that illustrate the complexity of human communication under stress.

Using T-Pattern Analysis, the research revealed that non-verbal and verbal behaviors interact in a structured manner during the TSST, emphasizing the importance of multimodal communication in understanding stress responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurring sequences of multimodal non-verbal and verbal communication during a human psycho-social stress test: A temporal pattern analysis. Santangelo, A., Monteleone, AM., Casarrubea, M., et al.[2021]

The remote Trier Social Stress Test (rTSST) effectively elicited negative affect and increased cardiovascular responses (like heart rate) in participants under stress compared to a control group, indicating its efficacy in simulating stress responses.

The rTSST demonstrated good test-retest reliability for cardiovascular responses when assessed one week later, suggesting it can be a reliable tool for future research on stress and its effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An online Trier social stress paradigm to evoke affective and cardiovascular responses. DuPont, CM., Pressman, SD., Reed, RG., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Validation of an online version of the Trier Social Stress Test in a study of adolescents. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Mood and autonomic responses to repeated exposure to the Trier Social Stress Test for Groups (TSST-G). [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Utility of a Virtual Trier Social Stress Test: Initial Findings and Benchmarking Comparisons. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Recurring sequences of multimodal non-verbal and verbal communication during a human psycho-social stress test: A temporal pattern analysis. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

An online Trier social stress paradigm to evoke affective and cardiovascular responses. [2022]