Recruiting

OM-OH

Sponsor:

Massachusetts General Hospital

Code:

NCT06001814

Conditions

Hiv

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

One-Mind One-Heart

Education

Study Details

Brief 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. 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

Study ID

NCT06001814

Start date

Jul 21, 2025

Status verified date

Sep, 2025

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. age ≥50 years
2. clinical diagnosis of HIV per medical record or provision of current antiretroviral medication prescription
3. viral suppression - i.e., lower than detectable limit - per medical record or provision of viral load test from the past six months
4. current elevated psychological distress (score ≥10 on 10-item Kessler Psychological Distress Scale \[K10\]) screener)
5. ≥1 CVD risk factor (based on ACC/AHA Atherosclerotic Cardiovascular Disease Risk Score Calculator; e.g., diabetes, current smoker, hypertension, and high cholesterol
6. access to cell phone with text messaging capabilities

Exclusion Criteria:

1. non-English-speaking
2. cognitive impairments preventing informed consent
3. untreated or under-treated serious mental illness (i.e., psychosis and bipolar disorder) based on clinical interview

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: One-Mind One-Heart

One-Mind One-Heart (OM-OH) is intended to be a mindfulness-based, behavior change intervention to reduce psychological and behavioral cardiovascular disease risk.

active comparator: Education

The education session will provide information on behaviors important for cardiovascular disease risk reduction.

Interventions

One-Mind One-Heart

One-Mind One-Heart will include mindfulness and behavior change skills to address psychological distress, physical activity, diet, and substance use.

Education

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.

Primary outcome measure

  • Feasibility of recruitment [ Time Frame: Baseline (pre-intervention) ]
  • Feasibility of eligibility criteria [ Time Frame: Baseline (pre-intervention) ]
  • Feasibility of randomization [ Time Frame: Pre-intervention ]
  • Feasibility of the OM-OM intervention [ Time Frame: Duration of intervention ]
  • Feasibility of research assessments [ Time Frame: Duration of intervention; 0 and 12-week follow-up ]
  • Feasibility of blood draws [ Time Frame: Baseline; 12-week follow-up ]
  • Acceptability of OM-OH intervention [ Time Frame: 0-weeks post-intervention ]
  • Acceptability of text-enhanced delivery [ Time Frame: 0-weeks post-intervention ]
  • Acceptability of blood draws [ Time Frame: 0- and 12-weeks post-intervention ]

Central Contacts and Locations

Central contacts

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-09-22.