Trauma and Cardiometabolic Health in an American Indian Community

Part of paid clinical trials in Browning, Montana.

Sponsor
Montana State University
Study ID
NCT06878885
Status
Recruiting
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Conditions

  • Cardiometabolic Conditions
  • Mental Health
  • Psychological Stress

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
May 10, 2024
Status verified
Mar 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

Changes in systolic blood pressure activity from baseline to task [ Time Frame: 10 minute resting baseline mean will be subtracted from the 4 minute task period for each value ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Blackfeet Community CollegeBrowningMontana59417
Betty Henderson-Matthews, MA
[email protected]
406-338-5441
Betty Henderson-Matthews, MA (PRINCIPAL_INVESTIGATOR)

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