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NCT Number: NCT06878885

Trauma and Cardiometabolic Health in an American Indian Community

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.

Recruiting

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Key information

Conditions

Psychological Stress Behavior Behavioral Symptoms CARDIOMETABOLIC CONDITIONS Mental Health Personal Satisfaction Psychological Well-Being Stress, Psychological

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blackfeet Community College

Browning, Montana, 59417, United States

Location status: Recruiting

Location contact

Betty Henderson-Matthews, MA

CONTACT

[email protected]

406-338-5441 ext. 2800

Betty Henderson-Matthews, MA

PRINCIPAL_INVESTIGATOR

About this study

This cross-sectional study will examine the association between factors of resiliency and trauma with physiological (cardiovascular, neuroendocrine, inflammatory) responses to acute stress and current mental and physical health. Study volunteers will include individuals who identify as American Indian and currently live on and near the Blackfeet Reservation. Study volunteers will be asked to provide information that will be used to measure: correlates of cardiometabolic and mental health, acute psychological stress, arterial stiffness. Results of the study will help increase knowledge of cardiometabolic and mental health in the context of past and ongoing trauma and resiliency.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18-40 years
  • Identifying as American Indian
  • Living on or near Blackfeet reservation

Exclusion criteria

  • Uncontrolled hypertension

Treatment and study plan

Acute psychological stress task (Paced Auditory Serial Addition Task)

Behavioral

Volunteers will complete a 4-minute Paced Auditory Serial Addition Task which is a standardized laboratory challenge that is widely used to monitor cardiovascular, neuroendocrine, and inflammatory responses in the laboratory.

Primary outcomes

  1. Changes in systolic blood pressure activity from baseline to task

    Time frame: 10 minute resting baseline mean will be subtracted from the 4 minute task period for each value

    The mean systolic blood pressure (mmHg) will be subtracted from the mean of the task period.

  2. Changes in diastolic blood pressure activity from baseline to task

    Time frame: 10 minute resting baseline mean will be subtracted from the 4 minute task period for each value

    The mean diastolic blood pressure (mmHg) will be subtracted from the mean of the task period.

  3. Changes in heart rate activity from baseline to task

    Time frame: 10 minute resting baseline mean will be subtracted from the 4 minute task period for each value

    The mean heart rate (bpm) will be subtracted from the mean of the task period.

  4. Change in cortisol from baseline to task

    Time frame: Baseline will be subtracted from the peak (15 minutes after task onset, 35 minute task onset)

    Salivary samples will be taken to measure cortisol (nmol/L) the mean from the peak stress period will be subtracted from the baseline

  5. Changes in IL-6 from baseline to task

    Time frame: Baseline will be subtracted from the level 30 minutes after task onset.

    IL-6 (pg/mL) measured at baseline will be subtracted from the IL-6 measured post task.

  6. Pulse wave velocity

    Time frame: 5 minutes

    Pulse wave velocity in m/s will be assessed by dual impedance cardiography as a non-invasive indicator of arterial stiffness. This measure will be derived from the 5 minute baseline period.

  7. Resting systolic blood pressure

    Time frame: 10 minutes

    Resting systolic blood pressure (mmHg)

  8. Resting diastolic blood pressure

    Time frame: 10 minutes

    Resting diastolic blood pressure (mmHg)

  9. Inflammatory and anti-inflammatory cytokines

    Time frame: 5 minutes

    Circulating levels of C-reactive protein, interleukin-6, tumor necrosis factor-a, monocyte chemoattractant protein-1, interleukin-1b, interleukin-10, and adiponectin will be assessed via a blood draw. A composite score will be created.

  10. Hemoglobin A1c

    Time frame: 5 minutes

    Hemoglobin A1c (nmol/L) will be assessed via blood draw

  11. Glucose

    Time frame: 5 minutes

    Glucose (nmol/L) will be assessed via blood draw

  12. Insulin

    Time frame: 5 minutes

    Insulin (mL) will be assessed via blood draw

  13. Cholesterol

    Time frame: 5 minutes

    Total cholesterol (mg) will be assessed via blood draw

  14. Low-density lipoprotein

    Time frame: 5 minutes

    Low-density lipoprotein (mg/dL) will be assessed via blood draw

  15. High-density lipoprotein

    Time frame: 5 minutes

    high-density lipoprotein (mg/dL) will be assessed via blood draw

  16. Triglycerides

    Time frame: 5 minutes

    Triglycerides (mmol/L) will be assessed via blood draw

  17. Waist circumference

    Time frame: 2 minutes

    Waist circumference

  18. Hip circumference

    Time frame: 2 minutes

    Hip circumference

  19. Depressive symptomology (Hospital Anxiety Depression Questionnaire depression subscale)

    Time frame: 10 minutes

    Hospital Anxiety Depression Questionnaire (depression subscale)

  20. Depressive symptomology (PHQ-9)

    Time frame: 10 minutes

    PHQ-9

  21. Anxiety symptomtology

    Time frame: 5 minutes

    Hospital Anxiety Depression Questionnaire (Anxiety subscale)

  22. Alcohol use

    Time frame: 10 minutes

    Alcohol use will be assessed using the Alcohol Use Identification Test

  23. Substance use

    Time frame: 5 minutes

    A cumulative score of substance use will be reported by indicating the number of recreational drugs "ever" tried

Study contacts

Contact information is provided by the study sponsor or research team.

Annie Ginty, PhD

CONTACT

[email protected]

(254)710-2236

Neha John-Henderson, PhD

CONTACT

[email protected]

(406) 994-6052

Sponsors and collaborators

Lead sponsor

Montana State University

Other

Collaborators

  • Baylor University
  • Blackfeet Community College
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: IHPIPO'TO'TSP

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2025
Registry last updated
Mar 17, 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.

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