Trauma and Cardiometabolic Health in an American Indian Community

This study is looking at the connection between experiences like trauma and resilience, and how your body responds to stress, as well as your current mental and physical health. It involves a behavioral intervention called the Paced Auditory Serial Addition Task, which is a short, challenging task used to measure how your heart, hormones, and inflammation react. Researchers will measure changes in your systolic blood pressure (the top number in a blood pressure reading), diastolic blood pressure (the bottom number), and heart rate during this task compared to when you are resting. The study is open to American Indian individuals aged 18 to 40 who live on or near the Blackfeet reservation and do not have uncontrolled high blood pressure. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 400 participants. It is a cross-sectional study, meaning it looks at data from a group of people at one specific point in time.
What's involved
You would participate in two laboratory sessions. These sessions involve providing a blood sample, completing questionnaires, body composition evaluations, and having cardiovascular, neuroendocrine, and inflammatory activity measured during rest and a short psychological task.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06878885

Trauma and Cardiometabolic Health in an American Indian Community

Recruiting
NAAges 18–40InterventionalBasic science
Montana State University
~400 participants
Updated 2025-03-17 on ClinicalTrials.gov
What's tested:Acute psychological stress task (Paced Auditory Serial Addition Task)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in systolic blood pressure activity from baseline to task
Measured over 10 minute resting baseline mean will be subtracted from the 4 minute task period for each value
+22 more outcomes measured
Psychological Stress
Cardiometabolic Conditions
Mental Health
1 sites across 1 states
Montana1
  • Neha John-Henderson, PhD · PRINCIPAL_INVESTIGATOR · Montana State University
  • Annie Ginty, PhD · PRINCIPAL_INVESTIGATOR · Baylor University
  • Betty Henderson-Mathews, MA · PRINCIPAL_INVESTIGATOR · Blackfeet Community College

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Eligibility criteria

Inclusion

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

Exclusion

Uncontrolled hypertension
  • Changes in systolic blood pressure activity from baseline to task10 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.

  • Changes in diastolic blood pressure activity from baseline to task10 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.

  • Changes in heart rate activity from baseline to task10 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.

  • Change in cortisol from baseline to taskBaseline 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

  • Changes in IL-6 from baseline to taskBaseline 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.

  • Pulse wave velocity5 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.

  • Resting systolic blood pressure10 minutes

    Resting systolic blood pressure (mmHg)

  • Resting diastolic blood pressure10 minutes

    Resting diastolic blood pressure (mmHg)

  • Inflammatory and anti-inflammatory cytokines5 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.

  • Hemoglobin A1c5 minutes

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

  • Glucose5 minutes

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

  • Insulin5 minutes

    Insulin (mL) will be assessed via blood draw

  • Cholesterol5 minutes

    Total cholesterol (mg) will be assessed via blood draw

  • Low-density lipoprotein5 minutes

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

  • High-density lipoprotein5 minutes

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

  • Triglycerides5 minutes

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

  • Waist circumference2 minutes

    Waist circumference

  • Hip circumference2 minutes

    Hip circumference

  • Depressive symptomology (Hospital Anxiety Depression Questionnaire depression subscale)10 minutes

    Hospital Anxiety Depression Questionnaire (depression subscale)

  • Depressive symptomology (PHQ-9)10 minutes

    PHQ-9

  • Anxiety symptomtology5 minutes

    Hospital Anxiety Depression Questionnaire (Anxiety subscale)

  • Alcohol use10 minutes

    Alcohol use will be assessed using the Alcohol Use Identification Test

  • Substance use5 minutes

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