Trauma and Cardiometabolic Health in an American Indian Community

NCT ID: NCT06878885

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-10

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psychological Stress Cardiometabolic Conditions Mental Health

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Acute psychological stress task (Paced Auditory Serial Addition Task)

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Uncontrolled hypertension
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Baylor University

OTHER

Sponsor Role collaborator

Blackfeet Community College

OTHER

Sponsor Role collaborator

Montana State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neha John-Henderson, PhD

Role: PRINCIPAL_INVESTIGATOR

Montana State University

Annie Ginty, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor University

Betty Henderson-Mathews, MA

Role: PRINCIPAL_INVESTIGATOR

Blackfeet Community College

Locations

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Blackfeet Community College

Browning, Montana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Neha John-Henderson, PhD

Role: CONTACT

(406) 994-6052

Annie Ginty, PhD

Role: CONTACT

(254)710-2236

Facility Contacts

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Betty Henderson-Matthews, MA

Role: primary

406-338-5441 ext. 2800

Other Identifiers

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5R01HL163237-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

163237

Identifier Type: -

Identifier Source: org_study_id

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