Psychological Stress Task for Cardiometabolic Conditions

(IHPIPO'TO'TSP Trial)

Overseen By Neha John-Henderson, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Montana State University

Disqualifiers: Uncontrolled hypertension

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

Compensation: Varies

Number of Visits: 2

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how stress affects the body's systems, such as the heart and hormones, particularly in individuals who have experienced trauma or possess strong coping skills. Participants will perform a psychological task involving simple math while under observation, and researchers will monitor their physiological responses. This research is crucial for understanding stress's impact on health, especially in those with cardiometabolic conditions. Individuals who identify as American Indian, live on or near the Blackfeet reservation, and do not have uncontrolled high blood pressure may find this trial suitable. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on stress and health.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this psychological stress task is safe?

Research has shown that the Paced Auditory Serial Addition Task (PASAT) is generally safe for participants. This test often assesses responses to stress. Studies have found that while the task can induce feelings of stress or anxiety, it does not cause physical harm. Participants have reported increased stress during the task, but these feelings subside once the task concludes. The PASAT is widely used in research to understand stress's effects on the body, and no serious side effects have been reported. Participants may stop the task at any time if it becomes too overwhelming. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Psychological Stress Task for Cardiometabolic Conditions because it explores how acute psychological stress impacts cardiometabolic health, something not typically addressed by existing treatments. Current options mostly focus on medication and lifestyle changes, but understanding stress's role could unveil new intervention strategies. This task is unique as it combines cognitive stress with self-observation, potentially providing deeper insights into the body's stress response. By measuring stress perceptions and responses, this study could pave the way for innovative approaches to managing cardiometabolic conditions.

What evidence suggests that this psychological stress task is effective for cardiometabolic conditions?

Research has shown that the Paced Auditory Serial Addition Task (PASAT), which participants in this trial will undertake, effectively induces short-term stress. In this task, participants listen to audio and add numbers, increasing mental effort and stress. Studies indicate that this leads to higher reported stress levels and affects performance. The task reliably tests how the body and mind respond to stress and can measure changes in blood pressure, indicating the body's reaction to stress. Overall, this task serves as a strong tool for studying stress and its effects on the body. ^{1 3 5 6 7}

Who Is on the Research Team?

Betty Henderson-Mathews, MA

Principal Investigator

Blackfeet Community College

Neha John-Henderson, PhD

Principal Investigator

Montana State University

Annie Ginty, PhD

Principal Investigator

Baylor University

Are You a Good Fit for This Trial?

This trial is for individuals from an American Indian community who are interested in understanding how stress affects their heart and metabolic health. Participants should be willing to provide blood samples, complete questionnaires, and undergo body composition evaluations.

Inclusion Criteria

Identifying as American Indian

Living on or near Blackfeet reservation

Exclusion Criteria

My blood pressure is not well-controlled.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Laboratory Session 1

Participants provide a blood sample, complete questionnaires, and undergo body composition evaluations

1 day

1 visit (in-person)

Laboratory Session 2

Participants undergo cardiovascular, neuroendocrine, and inflammatory activity measurements during rest and a psychological task, and complete questionnaires

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the laboratory sessions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acute psychological stress task (Paced Auditory Serial Addition Task)

Trial Overview The study tests how experiences like trauma affect the body's cardiovascular, neuroendocrine, and inflammatory responses during rest and a psychological challenge (Paced Auditory Serial Addition Task).

How Is the Trial Designed?

Group I: Paced Auditory Serial Addition Task Experimental Treatment 1 Intervention

Volunteers are presented with an audio playing of single digit numbers between 1 and 9. They are instructed to add the number with the number previously presented and say the answer out loud. Volunteers are told their performance is being scored by research assistants. Volunteers are also instructed to look at themselves in a mirror while partaking in the task. Volunteers are informed they can discontinue at any time. Volunteers complete brief questionnaires before and after the task to asses their perceptions of stress, arousal, and anxiety.

Who Is Running the Clinical Trial?

Montana State University

Lead Sponsor

Trials

47

Recruited

1,044,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Baylor University

Collaborator

Trials

65

Recruited

67,600+

Blackfeet Community College

Collaborator

Trials

2

Recruited

470+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25495065/

Effects of the Paced Auditory Serial Addition Task (PASAT) ... Increased PASAT rates were associated with decreases in correct responses (P < 0·001) and increases in self-reported levels of stress (P < 0·001).

2. researchgate.net researchgate.net/publication/7478594_A_comprehensive_review_of_the_Paced_Auditory_Serial_Addition_Test_PASAT

A comprehensive review of the Paced Auditory Serial ... The PASAT is known to impose a high cognitive load, making it an effective tool for assessing mental workload and stress responses in time- ...

3. eprints.lib.hokudai.ac.jp eprints.lib.hokudai.ac.jp/dspace/bitstream/2115/61460/1/JOR42%285%29.pdf

Effects of the Paced Auditory Serial Addition Task (PASAT) ... The Paced Auditory Serial Addition Task (PASAT) is known as an effective mental arithmetic task to evoke acute stress [8]. In the task, the subjects are ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/psyp.13707

Blunted cardiovascular reactivity to acute psychological ... This study found that low Paced Auditory Serial Addition Test (PASAT) systolic blood pressure (SBP) and diastolic blood pressure (DBP) ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06878885?cond=Native-american%20Health&lastUpdPost=2020-08-27_&viewType=Table&rank=10

Trauma and Cardiometabolic Health in an American Indian ... Volunteers will complete a 4-minute Paced Auditory Serial Addition Task which is a standardized laboratory challenge that is widely used to monitor ...

6. semanticscholar.org semanticscholar.org/paper/179e90ef92c4da0efa1a5f1caada4f230be1bcec

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7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22813228/

A Paced Auditory Serial Addition Task evokes stress and ... This study aimed to determine autonomic and jaw-muscle activities, and haemodynamic responses, to acute experimental mental stress in humans.