Trauma and Cardiometabolic Health in an American Indian Community (IHPIPO'TO'TSP)

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.

Study Overview

• Status: Recruiting
• Conditions: Mental Health; Psychological Stress; Cardiometabolic Conditions
• Intervention / Treatment: Behavioral: Acute psychological stress task (Paced Auditory Serial Addition Task)

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neha John-Henderson, PhD; Phone Number: (406) 994-6052; Email: neha.johnhenderson@montana.edu
• Study Contact Backup: Name: Annie Ginty, PhD; Phone Number: (254)710-2236; Email: annie_ginty@baylor.edu

Study Locations

• United States
  • Montana
    • Browning, Montana, United States, 59417
      • Recruiting
      • Blackfeet Community College
      • Contact: Betty Henderson-Matthews, MA; Phone Number: 2800 406-338-5441; Email: b_mathews@bfcc.edu
      • Principal Investigator: Betty Henderson-Matthews, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Uncontrolled hypertension

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 minutes
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.	10 minute resting baseline mean will be subtracted from the 4 minute task period for each value
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.	10 minute resting baseline mean will be subtracted from the 4 minute task period for each value
Changes in heart rate activity from baseline to task	The mean heart rate (bpm) will be subtracted from the mean of the task period.	10 minute resting baseline mean will be subtracted from the 4 minute task period for each value
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	Baseline will be subtracted from the peak (15 minutes after task onset, 35 minute task onset)
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.	Baseline will be subtracted from the level 30 minutes after task onset.
Resting systolic blood pressure	Resting systolic blood pressure (mmHg)	10 minutes
Resting diastolic blood pressure	Resting diastolic blood pressure (mmHg)	10 minutes
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.	5 minutes
Hemoglobin A1c	Hemoglobin A1c (nmol/L) will be assessed via blood draw	5 minutes
Glucose	Glucose (nmol/L) will be assessed via blood draw	5 minutes
Insulin	Insulin (mL) will be assessed via blood draw	5 minutes
Cholesterol	Total cholesterol (mg) will be assessed via blood draw	5 minutes
Low-density lipoprotein	Low-density lipoprotein (mg/dL) will be assessed via blood draw	5 minutes
High-density lipoprotein	high-density lipoprotein (mg/dL) will be assessed via blood draw	5 minutes
Triglycerides	Triglycerides (mmol/L) will be assessed via blood draw	5 minutes
Waist circumference	Waist circumference	2 minutes
Hip circumference	Hip circumference	2 minutes
Depressive symptomology (Hospital Anxiety Depression Questionnaire depression subscale)	Hospital Anxiety Depression Questionnaire (depression subscale)	10 minutes
Depressive symptomology (PHQ-9)	PHQ-9	10 minutes
Anxiety symptomtology	Hospital Anxiety Depression Questionnaire (Anxiety subscale)	5 minutes
Alcohol use	Alcohol use will be assessed using the Alcohol Use Identification Test	10 minutes
Substance use	A cumulative score of substance use will be reported by indicating the number of recreational drugs "ever" tried	5 minutes

Collaborators and Investigators

• Sponsor: Montana State University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Baylor University; Blackfeet Community College
• Investigators: Principal Investigator: Neha John-Henderson, PhD, Montana State University; Principal Investigator: Annie Ginty, PhD, Baylor University; Principal Investigator: Betty Henderson-Mathews, MA, Blackfeet Community College

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: 163237 (JAPIC-CTI); 5R01HL163237-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No