StressNCT06811896
Adapting a Stress Management Intervention to Reduce Cardiovascular Disease Risk
A study testing Stress Management and Resiliency Training Program in people with Stress and Blood Pressure, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Women living with HIV have 2-4x higher risk for cardiovascular disease compared to women without HIV, with women living with HIV in the Southern US being particularly at risk. While an increased prevalence of traditional risk factors (e.g., hypertension, diabetes, and obesity) partially explain this risk, evidence… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress, Blood Pressure, Cardiovascular Diseases (CVD)
- What is being tested?
- Stress Management and Resiliency Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2025to Apr 2028
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cis-gender females at least 18 years of age
- HIV-seropositive and a patient of the recruiting clinic
- English speaking
Who cannot join
- severe mental illness
- not being willing able to provide informed consent
- not willing or able to attend study visits
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 Alabama at Birmingham
Birmingham, Alabama, 35294
Jenni Wise, PhD, MSN, 2059969459, jmwise@uab.edu
About this study
Official title: Adapting and Piloting a Stress Management Intervention to Reduce Cardiovascular Disease Risk Among Women Living With HIV
Women living with HIV have 2-4x higher risk for cardiovascular disease compared to women without HIV, with women living with HIV in the Southern US being particularly at risk. While an increased prevalence of traditional risk factors (e.g., hypertension, diabetes, and obesity) partially explain this risk, evidence suggests that increased exposure to structural and social stressors (e.g., poverty, discrimination, and stigma) among women living with HIV in the South negatively contribute to cardiovascular disease disparities through their impact on stress. The Stress Management and Resiliency Training (SMART) program is an effective, evidence-based intervention proven to improve resiliency to environmental stressors and reduce the physiologic responses to stress which contribute to cardiovascular disease. While the SMART program has demonstrated efficacy in a wide range of populations and settings, it has not been designed for or tested among women living with HIV in the South, where unique cultural and faith-based context may diminish the uptake and value of the intervention to mitigate cardiovascular disease risk. The purpose of this study is to adapt the evidence-based SMART program in consideration of the needs and contexts of women living with HIV in the Southern US and pilot the adapted intervention to establish the feasibility, acceptability, and preliminary impact of the adapted intervention to reduce stress and mitigate cardiovascular disease risk among this population.
- Conditions
- Stress, Blood Pressure, Cardiovascular Diseases (CVD)
- Being tested
- Stress Management and Resiliency Training Program, Usual Care
- Keywords
- stress, resiliency, meditation, blood pressure, cardiovascular risk
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Management and Resiliency Training ProgramBehavioural
The Stress Management and Resiliency Training Intervention is an evidence-based intervention to reduce physiologic responses to stress that may contribute to cardiovascular disease risk. The intervention is typically delivered over an 8-week period and works to decrease stress responses by improving psychological resiliency to structural and social stressors and decreasing sympathetic nervous system activation. Eliciting the relaxation response through meditation, mindfulness, and autogenic training are core components.
Usual CareOther
Usual social and clinical services provided to patients at the recruiting clinic
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Usual Care Receives: Other: Usual Care |
| Intervention | Other | Adapted Intervention, Previously Established Receives: Behavioral: Stress Management and Resiliency Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure at baseline, week 8, and week 20
Measure blood pressure at baseline, end of intervention, and at 12-week follow-up
Measured: baseline - week 8 - week 20
Change in Center for Epidemiological Studies Depression Scale Score
Higher score indicates more depressive symptoms (0-60 Range)
Measured: baseline - week 8 - week 20
Change in Generalized Anxiety Disorder-7 Scale Score
Higher scores indicate greater symptoms of anxiety (0-21 Range)
Measured: baseline - week 8 - week 20
Changes in Perceived Stress Scale Scores
Higher scores indicate greater perceived stress (0 - 40 Range)
Measured: baseline - week 8 - week 20
Changes in Connor-Davidson Resilience Scale
Higher scores indicate greater resilience (0-100 Range)
Measured: baseline - week 8 - week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start14 May 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jenni Wise, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811896
- Sponsor's protocol ID
- IRB-300012154
- Other IDs
- 1K23HL170836-01A1
- Status last verified
- Sep 2026
- First submitted
- 31 Jan 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting and Piloting a Stress Management Intervention to Reduce Cardiovascular Disease Risk Among Women Living With HIV
- ClinicalTrials.gov ID
- NCT06811896
- Acronym / sponsor ID
- IRB-300012154
- Conditions
- Stress, Blood Pressure, Cardiovascular Diseases (CVD)
- Keywords
- stress, resiliency, meditation, blood pressure, cardiovascular risk
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 14 May 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 6 Feb 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.
Women living with HIV have 2-4x higher risk for cardiovascular disease compared to women without HIV, with women living with HIV in the Southern US being particularly at risk. While an increased prevalence of traditional risk factors (e.g., hypertension, diabetes, and obesity) partially explain this risk, evidence suggests that increased exposure to structural and social stressors (e.g., poverty, discrimination, and stigma) among women living with HIV in the South negatively contribute to cardiovascular disease disparities through their impact on stress. The Stress Management and Resiliency Training (SMART) program is an effective, evidence-based intervention proven to improve resiliency to environmental stressors and reduce the physiologic responses to stress which contribute to cardiovascular disease. While the SMART program has demonstrated efficacy in a wide range of populations and settings, it has not been designed for or tested among women living with HIV in the South, where unique cultural and faith-based context may diminish the uptake and value of the intervention to mitigate cardiovascular disease risk. The purpose of this study is to adapt the evidence-based SMART program in consideration of the needs and contexts of women living with HIV in the Southern US and pilot the adapted intervention to establish the feasibility, acceptability, and preliminary impact of the adapted intervention to reduce stress and mitigate cardiovascular disease risk among this population.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Usual CareUsual Care |
| Intervention | Other | Behavioral: Stress Management and Resiliency Training ProgramAdapted Intervention, Previously Established |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- cis-gender females at least 18 years of age
- HIV-seropositive and a patient of the recruiting clinic
- English speaking
Key exclusion criteria (3 listed)
- severe mental illness
- not being willing able to provide informed consent
- not willing or able to attend study visits
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 |
|---|---|---|
| Stress Management and Resiliency Training ProgramThe Stress Management and Resiliency Training Intervention is an evidence-based intervention to reduce physiologic responses to stress that may contribute to cardiovascular disease risk. The intervention is typically delivered over an 8-week period and works to decrease stress responses by improving psychological resiliency to structural and social stressors and decreasing sympathetic nervous system activation. Eliciting the relaxation response through meditation, mindfulness, and autogenic training are core components. | Behavioural | Intervention |
| Usual CareUsual social and clinical services provided to patients at the recruiting clinic | Other | Control |
Primary outcome
Change in blood pressure at baseline, week 8, and week 20
Time frame: baseline - week 8 - week 20
Measure blood pressure at baseline, end of intervention, and at 12-week follow-up
Change in Center for Epidemiological Studies Depression Scale Score
Time frame: baseline - week 8 - week 20
Higher score indicates more depressive symptoms (0-60 Range)
Change in Generalized Anxiety Disorder-7 Scale Score
Time frame: baseline - week 8 - week 20
Higher scores indicate greater symptoms of anxiety (0-21 Range)
Changes in Perceived Stress Scale Scores
Time frame: baseline - week 8 - week 20
Higher scores indicate greater perceived stress (0 - 40 Range)
Changes in Connor-Davidson Resilience Scale
Time frame: baseline - week 8 - week 20
Higher scores indicate greater resilience (0-100 Range)
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 28 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Management and Resiliency Training Program in people with Stress and Blood Pressure, run by University of Alabama at Birmingham 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 3 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 28 Sep 2026. 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 Jenni Wise, PhD, MSN (2059969459, jmwise@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure at baseline, week 8, and week 20 (time frame: baseline - week 8 - week 20). The study lists 5 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 28 Sep 2026.