HivOM-OHNCT06001814
Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV
A study testing One-Mind One-Heart and Education in people with Hiv and Cardiovascular Diseases, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Older people with HIV (OPWH) are disproportionately impacted by cardiovascular disease (CVD) attributable to behavioral risk factors, and chronic HIV immune dysregulation resulting inflammation. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv, Cardiovascular Diseases
- What is being tested?
- One-Mind One-Heart and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2025to 31 Aug 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥50 years
- clinical diagnosis of HIV per medical record or provision of current antiretroviral medication prescription
- viral suppression - i.e., lower than detectable limit - per medical record or provision of viral load test from the past six months
- current elevated psychological distress (score ≥10 on 10-item Kessler Psychological Distress Scale [K10]) screener)
- ≥1 CVD risk factor (based on ACC/AHA Atherosclerotic Cardiovascular Disease Risk Score Calculator; e.g., diabetes, current smoker, hypertension, and high cholesterol
- access to cell phone with text messaging capabilities
Who cannot join
- non-English-speaking
- cognitive impairments preventing informed consent
- untreated or under-treated serious mental illness (i.e., psychosis and bipolar disorder) based on clinical interview
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
Massachusetts General Hospital
Boston, Massachusetts, 02114
Jacklyn Foley, PhD
About this study
Older people with HIV (OPWH) are disproportionately impacted by cardiovascular disease (CVD) attributable to behavioral risk factors, and chronic HIV immune dysregulation resulting inflammation. Systemic inflammation is exacerbated by psychological distress via activating the immune response and driving pro-inflammatory CVD risk behaviors. There is promising evidence to suggest that mindfulness could be an effective intervention to reduce psychological distress and support behaviorally- and inflammatory-mediated CVD risk reduction. This project aims to refine and synthesize mindfulness and behavior change content from evidence-based protocols (mindfulness-based stress reduction and diabetes prevention program) to develop and pilot test a new text message-enhanced intervention called "One Mind One Heart" (OM-OH) using feedback from semi-structured interviews with OPWH in psychological distress (N=20), and my multidisciplinary mentorship team (Aim 1). An open pilot (N=5) with exit interviews and pre-post self-report assessments, will inform the initial acceptability of OM-OH and further refine OM-OH as needed (Aim 2). Finally, a pilot randomized controlled trial (RCT; N=50) will be conducted to a.) evaluate benchmarks of feasibility and acceptability of study methods and refined OM-OH compared to enhanced usual care, and b.) investigate potential for effects on psychological distress, inflammation, and behavioral CVD risk (Aim 3). Findings will provide the foundation for an R01 application to conduct an efficacy trial of OM-OH to reduce inflammatory-mediated CVD risk among OPWH.
- Conditions
- Hiv, Cardiovascular Diseases
- Being tested
- One-Mind One-Heart, Education
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-Mind One-HeartBehavioural
One-Mind One-Heart will include mindfulness and behavior change skills to address psychological distress, physical activity, diet, and substance use.
EducationOther
Education will be provided on behavioral cardiovascular disease risk reduction strategies, such as increasing physical activity, reducing salt intake in diet, and reduce/stop alcohol and tobacco-use.
| Study group | Role | What they receive |
|---|---|---|
| One-Mind One-Heart | Experimental | One-Mind One-Heart (OM-OH) is intended to be a mindfulness-based, behavior change intervention to reduce psychological and behavioral cardiovascular disease risk. Receives: Behavioral: One-Mind One-Heart |
| Education | Active comparator | The education session will provide information on behaviors important for cardiovascular disease risk reduction. Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
70% or more of participants consent to screening, meet screening criteria, are eligible, and agree to participate in the study
Measured: Baseline (pre-intervention)
Feasibility of eligibility criteria
Less than 20% of participants are ineligible due to each criterion
Measured: Baseline (pre-intervention)
Feasibility of randomization
70% or more of participants are randomized and complete the first intervention session
Measured: Pre-intervention
Feasibility of the OM-OM intervention
70% or more of participants attend all sessions and complete all homework
Measured: Duration of intervention
Feasibility of research assessments
70% or more of weekly and follow-up research assessments are completed
Measured: Duration of intervention; 0 and 12-week follow-up
Feasibility of blood draws
70% of more are collected
Measured: Baseline; 12-week follow-up
Acceptability of OM-OH intervention
Rating of 7.5 or greater/10 on: session satisfaction, helpfulness, and utility; overall program satisfaction; plan to use the skills; and would recommend the intervention program to a friend
Measured: 0-weeks post-intervention
Acceptability of text-enhanced delivery
Rating of 7.5 or greater/10 on: ease, and confidence of use; and rating of 2 or less/10 on interference of technical problems
Measured: 0-weeks post-intervention
Acceptability of blood draws
Rating of 7.5 or greater/10 on ease of collection; and rating of 2 or less/10 on pain
Measured: 0- and 12-weeks post-intervention
Secondary outcomes (10)
Five Factor Mindfulness Questionnaire (FFMQ)
The FFQ assesses trait mindfulness.There are five sub scales: observing, describing, acting with awareness, non-judging, and non-reactivity. The FFMQ sub scale summary scores can be calculated by dividing the total in each category by the number of items in that category. The FFMQ sum score can be divided by 39 to get an average item score. Higher scores indicated greater trait mindfulness.
Measured: 0 and 12-weeks post-intervention
Patient Health Questionnaire - 9 (PHQ-9)
PHQ-9 assesses depressive symptoms. Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depressive symptoms, respectively.
Measured: 0 and 12-weeks post-intervention
Generalized Anxiety Disorder - 7 (GAD-7)
GAD-7 assesses anxiety symptoms. Total scores of 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety symptoms, respectively.
Measured: 0 and 12-weeks post-intervention
Perceived Stress Scale (PSS)
The PSS assessed perceived stress. Scores on the PSS range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Measured: 0 and 12-weeks post-intervention
HIV/AIDS Stress Scale
The HIV/AIDS Stress Scale assesses HIV-related stress. The total score ranges from 0-68, with higher scores indicating higher levels of HIV-related stress.
Measured: 0 and 12-weeks post-intervention
Alcohol Use Disorder Identification Test - Concise (AUDIT-C)
The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive for hazardous drinking; in women, a score of 3 or more is considered positive for hazardous drinking. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.
Measured: 0 and 12-weeks post-intervention
Physical Activity and Sedentary Behavior Questionnaire (PASBQ)
The PASBQ assesses frequency and time spent in physical activity and sedentary behaviors. These time will be compared to Centers for Disease Control and Prevention (CDC) to determine if current guidelines are being met (yes/no) for 150 minutes of moderate aerobic activity (or 75 minutes of vigorous aerobic activity) and 2 or more days of muscle strengthening activities.
Measured: 0 and 12-weeks post-intervention
Dietary Risk Assessment (DRA)
The DRA assesses dietary patterns. A total DRA score and 4 subscales (Nuts, Oils, Dressings, and Spreads; Vegetables, Fruit, Whole Grains, and Beans; Drinks, Desserts, Snacks, Eating Out, and Salt; and Fish, Meat, Poultry, Dairy, and Eggs) can be derived. Subscales are scored independently by assigning score values accordingly: 2 for response choices in the "Desirable" column; 1 for response choices in the "Could be improved" column; and 0 for response choices in the "Needs to be improved" column. Sum the 4 subscales to obtain a total DRA score ranging 0 to 46. For all scoring, a higher score represents a more healthful dietary pattern.
Measured: 0 and 12-weeks post-intervention
Fagerstrom Test For Nicotine Dependence (FTND)
The FTND assesses dependence on nicotine. Scores for all item are summed. Scores of �1-2: low dependence; 3-4 low to moderate dependence; 5-7 moderate dependence; 8+ high dependence.
Measured: 0 and 12-weeks post-intervention
Inflammation Biomarkers
Interleukin-6 and C-reactive protein measured in picograms per milliliter of blood
Measured: 0- and 12-weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start21 Jul 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jacklyn D. Foley, Ph.D, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001814
- Sponsor's protocol ID
- 2023P002014
- Other IDs
- PA20-206, 1K23HL167650-01A1
- Acronym
- OM-OH
- Status last verified
- Sep 2025
- First submitted
- 3 Aug 2023
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We plan to share aggregated data only.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV
- ClinicalTrials.gov ID
- NCT06001814
- Acronym / sponsor ID
- OM-OH / 2023P002014
- Conditions
- Hiv, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 21 Aug 2023 (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.
Older people with HIV (OPWH) are disproportionately impacted by cardiovascular disease (CVD) attributable to behavioral risk factors, and chronic HIV immune dysregulation resulting inflammation. Systemic inflammation is exacerbated by psychological distress via activating the immune response and driving pro-inflammatory CVD risk behaviors. There is promising evidence to suggest that mindfulness could be an effective intervention to reduce psychological distress and support behaviorally- and inflammatory-mediated CVD risk reduction. This project aims to refine and synthesize mindfulness and behavior change content from evidence-based protocols (mindfulness-based stress reduction and diabetes prevention program) to develop and pilot test a new text message-enhanced intervention called "One Mind One Heart" (OM-OH) using feedback from semi-structured interviews with OPWH in psychological distress (N=20), and my multidisciplinary mentorship team (Aim 1). An open pilot (N=5) with exit interviews and pre-post self-report assessments, will inform the initial acceptability of OM-OH and further refine OM-OH as needed (Aim 2). Finally, a pilot randomized controlled trial (RCT; N=50) will be conducted to a.) evaluate benchmarks of feasibility and acceptability of study methods and refined OM-OH compared to enhanced usual care, and b.) investigate potential for effects on psychological distress, inflammation, and behavioral CVD risk (Aim 3). Findings will provide the foundation for an R01 application to conduct an efficacy trial of OM-OH to reduce inflammatory-mediated CVD risk among OPWH.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-Mind One-Heart | Experimental | Behavioral: One-Mind One-HeartOne-Mind One-Heart (OM-OH) is intended to be a mindfulness-based, behavior change intervention to reduce psychological and behavioral cardiovascular disease risk. |
| Education | Active comparator | Other: EducationThe education session will provide information on behaviors important for cardiovascular disease risk reduction. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age ≥50 years
- clinical diagnosis of HIV per medical record or provision of current antiretroviral medication prescription
- viral suppression - i.e., lower than detectable limit - per medical record or provision of viral load test from the past six months
- current elevated psychological distress (score ≥10 on 10-item Kessler Psychological Distress Scale [K10]) screener)
- ≥1 CVD risk factor (based on ACC/AHA Atherosclerotic Cardiovascular Disease Risk Score Calculator; e.g., diabetes, current smoker, hypertension, and high cholesterol
Key exclusion criteria (3 listed)
- non-English-speaking
- cognitive impairments preventing informed consent
- untreated or under-treated serious mental illness (i.e., psychosis and bipolar disorder) based on clinical interview
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 |
|---|---|---|
| One-Mind One-HeartOne-Mind One-Heart will include mindfulness and behavior change skills to address psychological distress, physical activity, diet, and substance use. | Behavioural | One-Mind One-Heart |
| EducationEducation will be provided on behavioral cardiovascular disease risk reduction strategies, such as increasing physical activity, reducing salt intake in diet, and reduce/stop alcohol and tobacco-use. | Other | Education |
Primary outcome
Feasibility of recruitment
Time frame: Baseline (pre-intervention)
70% or more of participants consent to screening, meet screening criteria, are eligible, and agree to participate in the study
Feasibility of eligibility criteria
Time frame: Baseline (pre-intervention)
Less than 20% of participants are ineligible due to each criterion
Feasibility of randomization
Time frame: Pre-intervention
70% or more of participants are randomized and complete the first intervention session
Feasibility of the OM-OM intervention
Time frame: Duration of intervention
70% or more of participants attend all sessions and complete all homework
Feasibility of research assessments
Time frame: Duration of intervention; 0 and 12-week follow-up
70% or more of weekly and follow-up research assessments are completed
Feasibility of blood draws
Time frame: Baseline; 12-week follow-up
70% of more are collected
Acceptability of OM-OH intervention
Time frame: 0-weeks post-intervention
Rating of 7.5 or greater/10 on: session satisfaction, helpfulness, and utility; overall program satisfaction; plan to use the skills; and would recommend the intervention program to a friend
Acceptability of text-enhanced delivery
Time frame: 0-weeks post-intervention
Rating of 7.5 or greater/10 on: ease, and confidence of use; and rating of 2 or less/10 on interference of technical problems
Acceptability of blood draws
Time frame: 0- and 12-weeks post-intervention
Rating of 7.5 or greater/10 on ease of collection; and rating of 2 or less/10 on pain
10 secondary outcomes
Five Factor Mindfulness Questionnaire (FFMQ)
Time frame: 0 and 12-weeks post-intervention
Patient Health Questionnaire - 9 (PHQ-9)
Time frame: 0 and 12-weeks post-intervention
Generalized Anxiety Disorder - 7 (GAD-7)
Time frame: 0 and 12-weeks post-intervention
Perceived Stress Scale (PSS)
Time frame: 0 and 12-weeks post-intervention
HIV/AIDS Stress Scale
Time frame: 0 and 12-weeks post-intervention
Alcohol Use Disorder Identification Test - Concise (AUDIT-C)
Time frame: 0 and 12-weeks post-intervention
Physical Activity and Sedentary Behavior Questionnaire (PASBQ)
Time frame: 0 and 12-weeks post-intervention
Dietary Risk Assessment (DRA)
Time frame: 0 and 12-weeks post-intervention
Fagerstrom Test For Nicotine Dependence (FTND)
Time frame: 0 and 12-weeks post-intervention
Inflammation Biomarkers
Time frame: 0- and 12-weeks post-intervention
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 22 Sep 2025.
- Individual participant dataSharing planned: No. We plan to share aggregated data only.
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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 One-Mind One-Heart and Education in people with Hiv and Cardiovascular Diseases, run by Massachusetts General Hospital 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 6 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 22 Sep 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 Jacklyn Foley, PhD (857-347-5312, jdfoley@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: Baseline (pre-intervention)). The study lists 9 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 22 Sep 2025.