Trauma and Cardiometabolic Health in an American Indian Community

NCT06878885 | Recruiting

• 2 other identifiers: 1632375R01HL163237-02
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychological Stress; Cardiometabolic Conditions; Mental Health

Outcome Measures

Primary Outcomes (23)

• 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.

• 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

• 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

Study Arms (1)

Paced Auditory Serial Addition Task

EXPERIMENTAL

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

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.

Paced Auditory Serial Addition Task

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Uncontrolled hypertension

Sponsors & Collaborators

• Montana State University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Baylor University: collaborator
• Blackfeet Community College: collaborator

Study Sites (1)

Blackfeet Community College

Browning, Montana, 59417, United States

RECRUITING

MeSH Terms

Conditions

Stress, Psychological; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Neha John-Henderson, PhD

  Montana State University

  PRINCIPAL INVESTIGATOR

• Annie Ginty, PhD

  Baylor University

  PRINCIPAL INVESTIGATOR

• Betty Henderson-Mathews, MA

  Blackfeet Community College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neha John-Henderson, PhD

CONTACT

(406) 994-6052; neha.johnhenderson@montana.edu

Annie Ginty, PhD

CONTACT

(254)710-2236; annie_ginty@baylor.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is designed to examine cardiovascular, neuroendocrine, and inflammatory responses to a brief (4 minutes) mental arithmetic task (i.e., a psychological challenge) in the laboratory. Cardiovascular activity will be measured during a resting baseline period (10 minutes) and during the task (4 minutes). Participants will provide salivary samples before the task and after the task (\~20-90 minutes) which will be used to assess neuroendocrine (i.e., cortisol) and inflammatory (i.e., IL-6). Cardiovascular, neuroendocrine, and inflammatory responses will be examined in relation to other study outcomes.

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: March 17, 2025
• Study Start: May 10, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

US (1)