Recruiting

Observational Study

Sponsor:

Montana State University

Code:

NCT06878885

Conditions

Psychological Stress

Cardiometabolic Conditions

Mental Health

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Acute psychological stress task (Paced Auditory Serial Addition Task)

Study Details

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

Study ID

NCT06878885

Start date

May 10, 2024

Status verified date

Mar, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Uncontrolled hypertension

Study Design

Enrollment

400 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

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.

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 ]
  • Changes in diastolic 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 ]
  • Changes in heart rate activity from baseline to task [ Time Frame: 10 minute resting baseline mean will be subtracted from the 4 minute task period for each value ]
  • Change in cortisol from baseline to task [ Time Frame: Baseline will be subtracted from the peak (15 minutes after task onset, 35 minute task onset) ]
  • Changes in IL-6 from baseline to task [ Time Frame: Baseline will be subtracted from the level 30 minutes after task onset. ]
  • Pulse wave velocity [ Time Frame: 5 minutes ]
  • Resting systolic blood pressure [ Time Frame: 10 minutes ]
  • Resting diastolic blood pressure [ Time Frame: 10 minutes ]
  • Inflammatory and anti-inflammatory cytokines [ Time Frame: 5 minutes ]
  • Hemoglobin A1c [ Time Frame: 5 minutes ]
  • Glucose [ Time Frame: 5 minutes ]
  • Insulin [ Time Frame: 5 minutes ]
  • Cholesterol [ Time Frame: 5 minutes ]
  • Low-density lipoprotein [ Time Frame: 5 minutes ]
  • High-density lipoprotein [ Time Frame: 5 minutes ]
  • Triglycerides [ Time Frame: 5 minutes ]
  • Waist circumference [ Time Frame: 2 minutes ]
  • Hip circumference [ Time Frame: 2 minutes ]
  • Depressive symptomology (Hospital Anxiety Depression Questionnaire depression subscale) [ Time Frame: 10 minutes ]
  • Depressive symptomology (PHQ-9) [ Time Frame: 10 minutes ]
  • Anxiety symptomtology [ Time Frame: 5 minutes ]
  • Alcohol use [ Time Frame: 10 minutes ]
  • Substance use [ Time Frame: 5 minutes ]

Central Contacts and Locations

Central contacts

Neha John-Henderson, PhD

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

Annie Ginty, PhD

(254)710-2236annie_ginty@baylor.edu

Locations

Blackfeet Community College

Recruiting

Browning, Montana, United States, 59417

Contacts

Betty Henderson-Matthews, MA

406-338-5441b_mathews@bfcc.edu

Principal Investigator:

Betty Henderson-Matthews, MA

More Information

Sponsor

Montana State University

Last update posted

Mar 17, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montana State University on 2025-03-17.