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

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

Compensation: Varies

Number of Visits: 2

400 Participants Needed

Trial Summary

What is the purpose of this trial?

Volunteers for the study are asked to participate in two laboratory sessions. In the first laboratory session, volunteers are asked to provide a blood sample which will be used to measure factors related to health. Participants also complete questionnaires related to demographic and health-related information and undergo evaluations of their body composition. In the second laboratory visit, participants are asked to have cardiovascular, neuroendocrine, and inflammatory activity measured during a brief period of rest and during a short challenging psychological task. Participants will also complete questionnaires. The study is designed to examine the associations between experiences such as trauma and resiliency with changes in bodily systems during a challenge and current health.

Research Team

Annie Ginty, PhD

Principal Investigator

Baylor University

Neha John-Henderson, PhD

Principal Investigator

Montana State University

Betty Henderson-Mathews, MA

Principal Investigator

Blackfeet Community College

Eligibility Criteria

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

I am between 18 and 40 years old.

Exclusion Criteria

My blood pressure is not well-controlled.

Timeline

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

Treatment Details

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).

Participant Groups

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+