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

Montana State University logo

Montana State University

Status

Enrolling

Conditions

Psychological Stress
Cardiometabolic Conditions
Mental Health

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06878885
163237 (Registry Identifier)
5R01HL163237-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Uncontrolled hypertension

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

400 participants in 1 patient group

Paced Auditory Serial Addition Task
Experimental group
Description:
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.
Treatment:
Behavioral: Acute psychological stress task (Paced Auditory Serial Addition Task)

Trial contacts and locations

1

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Central trial contact

Annie Ginty, PhD; Neha John-Henderson, PhD

Data sourced from clinicaltrials.gov

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