Psychological StressIHPIPO'TO'TSPNCT06878885
Trauma and Cardiometabolic Health in an American Indian Community
A study testing Acute psychological stress task (Paced Auditory Serial Addition Task) in people with Psychological Stress and Cardiometabolic Conditions, run by Montana State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress, Cardiometabolic Conditions, Mental Health
- What is being tested?
- Acute psychological stress task (Paced Auditory Serial Addition Task)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-40 years
- Identifying as American Indian
- Living on or near Blackfeet reservation
Who cannot join
- Uncontrolled hypertension
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Blackfeet Community College
Browning, Montana, 59417
Betty Henderson-Matthews, MA, 406-338-5441 ext. 2800, b_mathews@bfcc.edu
Betty Henderson-Matthews, MA
About this study
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.
Read the detailed 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.
- Being tested
- Acute psychological stress task (Paced Auditory Serial Addition Task)
- Medical subject headings
- Stress, Psychological, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute psychological stress task (Paced Auditory Serial Addition Task)Behavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Acute psychological stress task (Paced Auditory Serial Addition Task) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 5 minutes
Resting systolic blood pressure
Resting systolic blood pressure (mmHg)
Measured: 10 minutes
Resting diastolic blood pressure
Resting diastolic blood pressure (mmHg)
Measured: 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.
Measured: 5 minutes
Hemoglobin A1c
Hemoglobin A1c (nmol/L) will be assessed via blood draw
Measured: 5 minutes
Glucose
Glucose (nmol/L) will be assessed via blood draw
Measured: 5 minutes
Insulin
Insulin (mL) will be assessed via blood draw
Measured: 5 minutes
Cholesterol
Total cholesterol (mg) will be assessed via blood draw
Measured: 5 minutes
Low-density lipoprotein
Low-density lipoprotein (mg/dL) will be assessed via blood draw
Measured: 5 minutes
High-density lipoprotein
high-density lipoprotein (mg/dL) will be assessed via blood draw
Measured: 5 minutes
Triglycerides
Triglycerides (mmol/L) will be assessed via blood draw
Measured: 5 minutes
Waist circumference
Waist circumference
Measured: 2 minutes
Hip circumference
Hip circumference
Measured: 2 minutes
Depressive symptomology (Hospital Anxiety Depression Questionnaire depression subscale)
Hospital Anxiety Depression Questionnaire (depression subscale)
Measured: 10 minutes
Depressive symptomology (PHQ-9)
PHQ-9
Measured: 10 minutes
Anxiety symptomtology
Hospital Anxiety Depression Questionnaire (Anxiety subscale)
Measured: 5 minutes
Alcohol use
Alcohol use will be assessed using the Alcohol Use Identification Test
Measured: 10 minutes
Substance use
A cumulative score of substance use will be reported by indicating the number of recreational drugs "ever" tried
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start10 May 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montana State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Baylor University, Blackfeet Community College
- Responsible party
- Sponsor
- Investigators
- Neha John-Henderson, PhD, Principal investigator, Montana State UniversityAnnie Ginty, PhD, Principal investigator, Baylor UniversityBetty Henderson-Mathews, MA, Principal investigator, Blackfeet Community College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878885
- Sponsor's protocol ID
- 163237
- Other IDs
- 5R01HL163237-02
- Acronym
- IHPIPO'TO'TSP
- Status last verified
- Mar 2025
- First submitted
- 10 Jan 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma and Cardiometabolic Health in an American Indian Community
- ClinicalTrials.gov ID
- NCT06878885
- Acronym / sponsor ID
- IHPIPO'TO'TSP / 163237
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Montana State UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Baylor University, Blackfeet Community College
- Study start
- 10 May 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Paced Auditory Serial Addition Task | Experimental | Behavioral: Acute psychological stress task (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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-40 years
- Identifying as American Indian
- Living on or near Blackfeet reservation
Key exclusion criteria (1 listed)
- Uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Paced Auditory Serial Addition Task |
Primary outcome
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
The mean systolic blood pressure (mmHg) will be subtracted from the mean of the task period.
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
The mean diastolic blood pressure (mmHg) will be subtracted from the mean of the task period.
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
The mean heart rate (bpm) will be subtracted from the mean of the task period.
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)
Salivary samples will be taken to measure cortisol (nmol/L) the mean from the peak stress period will be subtracted from the baseline
Changes in IL-6 from baseline to task
Time frame: Baseline will be subtracted from the level 30 minutes after task onset.
IL-6 (pg/mL) measured at baseline will be subtracted from the IL-6 measured post task.
Pulse wave velocity
Time frame: 5 minutes
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.
Resting systolic blood pressure
Time frame: 10 minutes
Resting systolic blood pressure (mmHg)
Resting diastolic blood pressure
Time frame: 10 minutes
Resting diastolic blood pressure (mmHg)
Inflammatory and anti-inflammatory cytokines
Time frame: 5 minutes
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.
Hemoglobin A1c
Time frame: 5 minutes
Hemoglobin A1c (nmol/L) will be assessed via blood draw
Glucose
Time frame: 5 minutes
Glucose (nmol/L) will be assessed via blood draw
Insulin
Time frame: 5 minutes
Insulin (mL) will be assessed via blood draw
Cholesterol
Time frame: 5 minutes
Total cholesterol (mg) will be assessed via blood draw
Low-density lipoprotein
Time frame: 5 minutes
Low-density lipoprotein (mg/dL) will be assessed via blood draw
High-density lipoprotein
Time frame: 5 minutes
high-density lipoprotein (mg/dL) will be assessed via blood draw
Triglycerides
Time frame: 5 minutes
Triglycerides (mmol/L) will be assessed via blood draw
Waist circumference
Time frame: 2 minutes
Waist circumference
Hip circumference
Time frame: 2 minutes
Hip circumference
Depressive symptomology (Hospital Anxiety Depression Questionnaire depression subscale)
Time frame: 10 minutes
Hospital Anxiety Depression Questionnaire (depression subscale)
Depressive symptomology (PHQ-9)
Time frame: 10 minutes
PHQ-9
Anxiety symptomtology
Time frame: 5 minutes
Hospital Anxiety Depression Questionnaire (Anxiety subscale)
Alcohol use
Time frame: 10 minutes
Alcohol use will be assessed using the Alcohol Use Identification Test
Substance use
Time frame: 5 minutes
A cumulative score of substance use will be reported by indicating the number of recreational drugs "ever" tried
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neha John-Henderson, PhD principal investigator
Montana State University
Annie Ginty, PhD principal investigator
Baylor University
Betty Henderson-Mathews, MA principal investigator
Blackfeet Community College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute psychological stress task (Paced Auditory Serial Addition Task) in people with Psychological Stress and Cardiometabolic Conditions, run by Montana State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neha John-Henderson, PhD ((406) 994-6052, neha.johnhenderson@montana.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.