Psychological StressCHARMNCT06029348
Cerebrovascular Health and Resilience in Midlife
A study testing Paced Auditory Serial Addition Task in people with Psychological Stress and Cardiovascular Diseases, run by University of Pittsburgh at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress, Cardiovascular Diseases, Cerebrovascular Disorders
- What is being tested?
- 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
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2023to 30 Jun 2029
- Phase
- Interventional
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 40 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to attend 2 study visits at the University of Pittsburgh campus in Oakland (Pennsylvania)
- Able to read and speak English
Who cannot join
- Uncontrolled hypertension (systolic blood pressure >160 or diastolic blood pressure >100 mmHg)
- Current use of anticonvulsant, anti-Parkinson, neuroleptic, or antipsychotic medications
- Current use of glucocorticoids (e.g., oral prednisone) or ephedrine
- Current chronic conditions of the lungs, liver and kidney, as well as cancer (chemotherapy and radiation) treatment in the past 12 months (allowances are made for non-melanoma skin cancer treatment, controlled asthma, and allergy inhalers)
- Self-reported major neurological disorders or brain injuries (e.g., multiple sclerosis, cerebral palsy, major head injury)
- Self-reported psychotic illnesses (mania, bipolar disorder, schizophrenia)
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- Current pregnancy or childbirth within the past 6 months
- Suspected mild cognitive impairment or dementia
- Self reported sleep apnea
- Self-reported history of myocardial infarction, stroke, or revascularization procedures, as well as treatment for cardiac arrhythmias
- Self-reported lack of comfort to undergo MRI testing
- Presence of implants or objects that are unsafe for MRI (e.g., tattooed eyeliner), as well as any other contraindications that would prevent MRI testing
- Self-reported lack of comfort to undergo the laboratory math task
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
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Sara Boyko, BS
About this study
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.
Read the detailed description
This cross-sectional study examines the extent to which cardiovascular responses to the acute experience of psychological stress relate to signs of cerebrovascular health detected on magnetic resonance imaging. Study volunteers will include midlife adults who do not report having a history of clinical cardiovascular disease or dementia. Study volunteers will be asked to complete protocols to assess: behavioral, social, and biological correlates of cardiovascular and cerebrovascular health; arterial stiffness, endothelial function, and beat-to-beat blood pressure; cardiovascular changes to acute psychological stress; signs of cerebrovascular health; and, neuropsychological test performance. Cardiovascular responses to acute psychological stress will be examined in relation to indicators of brain function and structure, as well as indicators of cardiac and vascular function. Study results may help to increase knowledge about stress-related factors and cardiovascular sources of brain health.
- Being tested
- Paced Auditory Serial Addition Task
- Medical subject headings
- Stress, Psychological, Cardiovascular Diseases, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paced Auditory Serial Addition TaskBehavioural
Study volunteers will be asked to complete a 4-minute Paced Auditory Serial Addition Task, which is a standardized task that is widely used to study cardiovascular responses to acute psychological challenges (or stressors) in a laboratory setting.
| Study group | Role | What they receive |
|---|---|---|
| Paced Auditory Serial Addition Task | Experimental | 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. Receives: Behavioral: Paced Auditory Serial Addition Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure (SBP) from baseline to task
The mean SBP from the baseline period will be subtracted from the mean of the task period.
Measured: Mean SBPs for the computation of change scores will be computed from the average of the 5 min baseline period and average of the 4 min task period
White matter hyperintensity burden
White matter hyperintensity burden will be computed as the total sum of the voxels segmented as hyperintensities multiplied by voxel dimensions to yield a total score (units of mm-cubed).
Measured: Derived from one acquisition sequence within in a 50 min multimodal MRI protocol
Hippocampal volume
Total bilateral hippocampal volume will be computed as the total sum of voxels automatically segmented.
Measured: Derived from one acquisition sequence within a 50 min multimodal MRI protocol
Perivascular space volume
Total perivascular space volume will be computed from segmented brain blood vessel-tissue interfaces.
Measured: Derived from one acquisition sequence in a 50 min multimodal MRI protocol
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
Spontaneous baroreflex sensitivity
Spontaneous baroreflex sensitivity in ms/mmHg will be computed by the sequence method applied to beat-to-beat blood pressure and electrocardiogram recordings.
Measured: 5 minutes
Endothelial function
Endothelial-dependent vasodilation will be measured non-invasively in a reactive hyperemia protocol using digital thermal monitoring.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start17 Oct 2023
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (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.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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 measure cardiovascular responses to brief (\~4 minute) mental arithmetic task (a psychological challenge) under laboratory conditions. Cardiovascular activity will be measured during (1) a resting period prior to the task (\~5min), then (2) during the task(\~4 min), and then (3) after the task is complete (\~10min) for all study volunteers. Cardiovascular responses will be examine in relation to other study outcome measures.
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Peter Gianaros, University of Pittsburgh
- Investigators
- Peter J Gianaros, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029348
- Sponsor's protocol ID
- STUDY23030073
- Other IDs
- R01HL169990
- Acronym
- CHARM
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that comprise primary and secondary study outcomes will be made available with data dictionaries via the University of Pittsburgh's repository, D-Scholarship@Pitt. This repository provides indefinite storage and accessibility. Along with de-identified data, other shared resources will include a description of data collection methods and study code book; a description of the data files; and descriptions of data use conditions. Statistical scripts will be deposited as appropriate following publication of manuscripts bearing on the aims of the study. All publications will include information on the location of study data and accessibility. Requests by researchers for other de-identified data will be facilitated by completion of a Data Use Agreement, as well as provision of a methodologically sound proposal and approval from their institution.