CClinicalTrials.gg
RecruitingNCT06878885IHPIPO'TO'TSPUpdated Mar 17, 2025

Trauma and Cardiometabolic Health in an American Indian Community

An interventional study of Acute psychological stress task (Paced Auditory Serial Addition Task) in Psychological Stress, Cardiometabolic Conditions and Mental Health, sponsored by Montana State University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-17.

Sponsored by Montana State University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled May 2024, registered Jan 2025).
  • Started May 2024; still recruiting 2 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Psychological Stress
  • Cardiometabolic Conditions
  • Mental Health

Browse trials for

03

In context

Stress, Psychological

783 studies on the registry are indexed under Stress, Psychological; 128 are open to participants now.

This study's planned enrollment of 400 is above the median of 85 across 632 interventional studies indexed under Stress, Psychological.

Browse Stress, Psychological studies →

Lead sponsor

Montana State University is the lead sponsor of 41 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Uncontrolled hypertension
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    Paced Auditory Serial Addition Task

    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.

    Behavioral: Acute psychological stress task (Paced Auditory Serial Addition Task)

Interventions

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

    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.

06

What researchers measure

Primary outcomes

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

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

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

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

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

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

  3. Changes in heart rate activity from baseline to task

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

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

  4. Change in cortisol from baseline to task

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

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

  5. Changes in IL-6 from baseline to task

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

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

  6. Pulse wave velocity

    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.

    Time frame: 5 minutes

  7. Resting systolic blood pressure

    Resting systolic blood pressure (mmHg)

    Time frame: 10 minutes

  8. Resting diastolic blood pressure

    Resting diastolic blood pressure (mmHg)

    Time frame: 10 minutes

  9. Inflammatory and anti-inflammatory cytokines

    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.

    Time frame: 5 minutes

  10. Hemoglobin A1c

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

    Time frame: 5 minutes

  11. Glucose

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

    Time frame: 5 minutes

  12. Insulin

    Insulin (mL) will be assessed via blood draw

    Time frame: 5 minutes

  13. Cholesterol

    Total cholesterol (mg) will be assessed via blood draw

    Time frame: 5 minutes

  14. Low-density lipoprotein

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

    Time frame: 5 minutes

  15. High-density lipoprotein

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

    Time frame: 5 minutes

  16. Triglycerides

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

    Time frame: 5 minutes

  17. Waist circumference

    Waist circumference

    Time frame: 2 minutes

  18. Hip circumference

    Hip circumference

    Time frame: 2 minutes

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

    Hospital Anxiety Depression Questionnaire (depression subscale)

    Time frame: 10 minutes

  20. Depressive symptomology (PHQ-9)

    PHQ-9

    Time frame: 10 minutes

  21. Anxiety symptomtology

    Hospital Anxiety Depression Questionnaire (Anxiety subscale)

    Time frame: 5 minutes

  22. Alcohol use

    Alcohol use will be assessed using the Alcohol Use Identification Test

    Time frame: 10 minutes

  23. Substance use

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

    Time frame: 5 minutes

07

Study locations

1 of 1 sites recruiting
  • Blackfeet Community College
    Browning, Montana 59417, United States
    • Betty Henderson-Matthews, MA · Contact · b_mathews@bfcc.edu · 406-338-5441
    • Betty Henderson-Matthews, MA · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06878885
Lead sponsor
Montana State University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Baylor University, Blackfeet Community College
Responsible party
Sponsor
First posted
Mar 17, 2025
Start date
May 10, 2024
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Mar 17, 2025

Study contacts

Neha John-Henderson, PhD
Contact
neha.johnhenderson@montana.edu
(406) 994-6052
Annie Ginty, PhD
Contact
annie_ginty@baylor.edu
(254)710-2236
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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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