Psychological Challenges for Cardiovascular Health

(CHARM Trial)

Overseen By Sara Boyko, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Anticonvulsants, Antipsychotics, Glucocorticoids, Ephedrine

Disqualifiers: Hypertension, Neurological disorders, Psychotic illnesses, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

450 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not currently use certain medications, such as anticonvulsants, anti-Parkinson drugs, neuroleptics, antipsychotics, glucocorticoids, or ephedrine. If you are taking any of these, you would need to stop before participating.

What data supports the effectiveness of the treatment Paced Auditory Serial Addition Task (PASAT) for cardiovascular health?

Research on mental stress testing, including tasks similar to PASAT, shows that these tasks can reliably increase heart rate and blood pressure, which are important measures in cardiovascular health studies. This suggests that PASAT may effectively assess cardiovascular responses to stress, potentially helping to identify and manage cardiovascular risks. ^{1 2 3 4 5}

Is the Paced Auditory Serial Addition Task (PASAT) safe for humans?

The PASAT is generally safe for humans, but it can cause anxiety and stress, as shown by increased stress responses in studies. However, these stress responses tend to decrease with repeated exposure, suggesting people may get used to it over time. ^{2 6 7 8 9}

How does the treatment in the Psychological Challenges for Cardiovascular Health trial differ from other treatments for cardiovascular conditions?

This treatment is unique because it focuses on psychological challenges, such as mental stress testing, to understand their impact on cardiovascular health, rather than using traditional drug-based approaches. It explores how tasks like mental arithmetic can affect heart rate and blood pressure, providing insights into the psychological factors influencing cardiovascular responses. ^{1 2 6 10 11}

What is the purpose of this trial?

This study examines cardiovascular responses to a brief psychological challenge under laboratory conditions among adult volunteers. The study volunteers are asked to complete two study sessions. In one session, the volunteers are asked to provide demographic and health-related information via questionnaires and an interview. In that session, volunteers would then be asked to undergo evaluations of their body composition, blood pressure, heart rate, and other signs of cardiovascular function and health. Lastly, volunteers would be asked to take part in a brief and challenging psychological task after a period of rest while cardiovascular activity is measured. In the other session, volunteers are asked to undergo magnetic resonance imaging and to complete neuropsychological tests of memory, attention, and processing speed. In addition to these two sessions, volunteers are asked to complete online questionnaires. The study is designed to examine associations between transient changes in cardiovascular activity induced by the psychological task, measures of overall cardiovascular health, and measures of cerebrovascular health measured by magnetic resonance imaging. Study results are expected to provide new information about the relationships between cardiovascular activity changes to psychological challenges and cardiovascular and cerebrovascular health in adults.

Research Team

Peter J Gianaros, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for adults who can visit the University of Pittsburgh twice, speak English, and have stable blood pressure. It's not for those with certain neurological disorders, recent major heart issues or surgeries, current pregnancy or childbirth within six months, use of specific medications like anticonvulsants or glucocorticoids, severe lung/liver/kidney diseases including cancer treatment in the past year (except non-melanoma skin cancer), mental health conditions like bipolar disorder or schizophrenia, discomfort with math tasks or MRI tests, sleep apnea diagnosis, and those with MRI-unsafe implants.

Inclusion Criteria

I can go to the University of Pittsburgh in Oakland for 2 study visits.

Exclusion Criteria

I may have mild memory loss or dementia.

Current pregnancy or childbirth within the past 6 months

You don't feel comfortable doing the math task in the lab.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Session 1

Participants provide demographic and health-related information, undergo evaluations of body composition, blood pressure, heart rate, and participate in a psychological task

1 day

1 visit (in-person)

Session 2

Participants undergo magnetic resonance imaging and complete neuropsychological tests of memory, attention, and processing speed

1 day

1 visit (in-person)

Follow-up

Participants complete online questionnaires to assess various psychological and health-related factors

2 weeks

Treatment Details

Interventions

• Paced Auditory Serial Addition Task

Trial Overview The study investigates how adult volunteers' cardiovascular systems respond to a psychological challenge. Participants will provide health information and undergo body composition assessments along with monitoring of blood pressure and heart rate. They'll also perform a challenging psychological task while their cardiovascular activity is measured. Additionally, they'll have an MRI scan and complete cognitive tests to explore links between cardiovascular responses to stressors and overall cerebrovascular health.

Participant Groups

Group I: Paced Auditory Serial Addition Task Experimental Treatment 1 Intervention

For the Paced Auditory Serial Addition Task, volunteers are presented with single digit numbers (1-9), and are instructed to add any given number to the previously presented number, and call out the answer. Volunteers are told that their performance is being monitored by research assistants. Volunteers are provided with a signaling device that they can use to discontinue testing. Lastly, participants will be asked to complete brief questionnaires to assess their levels of experienced threat, challenge, valence, arousal, and sense of control.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

The study reviews the reliability and validity of various mental stress tests in cardiovascular research, categorizing them into five types and emphasizing the importance of selecting appropriate tests based on practical and theoretical criteria.

Analysis of cardiovascular responses to mental stress tests showed that heart rate and blood pressure reactions are relatively stable over time, with heart rate showing the strongest test-retest correlation, indicating that these tests can be reliable measures for assessing cardiovascular responses to mental stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methodology of mental stress testing in cardiovascular research. Steptoe, A., Vögele, C.[2008]

Vocal delivery of responses during mental arithmetic tasks increased subjective distress and negatively impacted performance, while also raising diastolic blood pressure.

Different types of noise distractions heightened distress levels but did not affect task performance, indicating that while distractions can increase stress, they may not necessarily hinder cognitive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do arithmetic stress tests measure? Protocol variations and cardiovascular responses. Linden, W.[2019]

In a study involving 80 healthy male students, social challenges during discussions caused significant increases in systolic blood pressure (SBP) and heart rate (HR), indicating a strong cardiovascular response to social stress.

Monetary incentives were found to enhance heart rate reactivity during these challenges, suggesting that external rewards can influence how our bodies respond to stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cardiovascular effects of active coping behavior in mental and social stress situations during various incentive conditions]. Gramer, M., Huber, HP.[2006]

In a study with 20 healthy male subjects, those who chose a 'difficult' mental arithmetic task exhibited significantly greater cardiovascular responses, including increased myocardial contractility and systolic blood pressure, compared to those who chose an 'easy' task.

The study suggests that allowing individuals to choose the difficulty of tasks may enhance the ecological validity of laboratory assessments of cardiovascular reactivity, although the findings are considered provocative and not definitive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular reactivity assessment: effects of choice of difficulty on laboratory task responses. Sherwood, A., Davis, MR., Dolan, CA., et al.[2019]

In a study of 60 healthy young men, those with high casual systolic pressure exhibited significantly greater increases in blood pressure and heart rate during challenging tasks compared to those with normal pressure, indicating heightened cardiovascular reactivity under stress.

The choice of task difficulty influenced cardiovascular responses, with individuals who opted for more difficult tasks showing greater increases in systolic pressure and heart rate, suggesting that psychological factors like fear of failure can impact cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laboratory reactivity assessment: effects of casual blood pressure status and choice of task difficulty. Sherwood, A., Royal, SA., Light, KC.[2019]

The Paced Auditory Serial Opposites Task (PASOT) was developed as a less anxiety-inducing alternative to the Paced Auditory Serial Addition Task (PASAT), showing a strong correlation (0.71) in cognitive assessment between the two tasks among 40 participants.

Participants reported significantly lower levels of negative feelings and anxiety while performing the PASOT compared to the PASAT, indicating that PASOT may be a more suitable option for assessing attention and concentration without inducing stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is the PASAT past it? Testing attention and concentration without numbers. Gow, AJ., Deary, IJ.[2008]

The new experimental stress protocol effectively induced significant stress responses in 32 healthy males, showing high test-retest stability for neuroendocrine and cardiovascular measures, which is important for future studies on stress reactivity.

Participants exhibited lower cortisol and subjective stress responses during the second exposure, indicating possible habituation or learning effects, while their performance on the cognitive task improved, suggesting the protocol's potential for repeated measures in research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Test-retest reproducibility of a combined physical and cognitive stressor. Bachmann, P., Finke, JB., Rebeck, D., et al.[2020]

In a study with 15 participants, faster rates of the Paced Auditory Serial Addition Task (PASAT) led to decreased accuracy in responses and increased self-reported stress levels, highlighting the task's impact on cognitive load and stress.

The autonomic responses, such as changes in heart rate and blood pressure, were significantly different when comparing the slowest PASAT (3.6 seconds) to faster rates, suggesting that a standardized PASAT rate could be crucial for accurately assessing stress and autonomic nervous system function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the Paced Auditory Serial Addition Task (PASAT) with different rates on autonomic nervous system responses and self-reported levels of stress. Tanosoto, T., Bendixen, KH., Arima, T., et al.[2015]

Blunted cardiovascular reactions to stress are linked to negative health outcomes, including increased risk of cardiovascular issues like myocardial infarction and behavioral problems such as obesity and depression, based on a review of 23 studies.

Specific thresholds for blunted cardiovascular reactivity were identified, with heart rate reductions of -3.00 to 12.59 bpm and blood pressure drops of -2.4 to 5.00 mmHg indicating higher risk, suggesting these measures could help clinicians identify at-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blunted cardiovascular reactivity to psychological stress and prospective health: a systematic review. O' Riordan, A., Howard, S., Gallagher, S.[2023]

In a study of 22 healthy adults, cardiovascular responses varied significantly between mental arithmetic stress and cold pressor stress, with mental arithmetic eliciting specific changes in T-wave amplitude and left ventricular ejection time.

Both stressors increased inter-beat intervals and subjective stress ratings, but mental arithmetic caused a more intense response, suggesting that cognitive processing level influences cardiovascular reactivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential beta- and alpha-adrenergic activation during psychological stress. Montoya, P., Brody, S., Beck, K., et al.[2019]

In a study of 566 healthy North American adults using a modified 200-item Paced Auditory Serial Addition Task (PASAT), age, education, and ethnicity were found to significantly influence test performance, explaining nearly 23% of the variance.

The research provides a formula and tables for calculating age, education, and ethnicity-adjusted T scores, which can help in accurately interpreting PASAT results in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Paced Auditory Serial Addition Task (PASAT): norms for age, education, and ethnicity. Diehr, MC., Heaton, RK., Miller, W., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Methodology of mental stress testing in cardiovascular research. [2008]

2. United States pubmed.ncbi.nlm.nih.gov

What do arithmetic stress tests measure? Protocol variations and cardiovascular responses. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

[Cardiovascular effects of active coping behavior in mental and social stress situations during various incentive conditions]. [2006]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Cardiovascular reactivity assessment: effects of choice of difficulty on laboratory task responses. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Laboratory reactivity assessment: effects of casual blood pressure status and choice of task difficulty. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Is the PASAT past it? Testing attention and concentration without numbers. [2008]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Test-retest reproducibility of a combined physical and cognitive stressor. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Effects of the Paced Auditory Serial Addition Task (PASAT) with different rates on autonomic nervous system responses and self-reported levels of stress. [2015]

9. England pubmed.ncbi.nlm.nih.gov

Blunted cardiovascular reactivity to psychological stress and prospective health: a systematic review. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Differential beta- and alpha-adrenergic activation during psychological stress. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

The Paced Auditory Serial Addition Task (PASAT): norms for age, education, and ethnicity. [2022]