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ReclutandoNCT06001814Registro de ClinicalTrials.gov

Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV

Hiv · Cardiovascular Diseases

LO ESENCIAL

De qué trata este estudio

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Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
50 años - No especificado
Sexo admitido
Todos los sexos
Voluntarios sanos
Aceptados
Participantes
50 Estimado

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Acerca de la investigación

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.

¿Quién podría participar?

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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

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
Asignación al azar
Enmascaramiento
Enmascaramiento simple
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.

Behavioral: One-Mind One-Heart

Education

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

Other: Education

One-Mind One-Heart BEHAVIORAL

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

Education OTHER

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.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Feasibility of recruitment

Plazo: 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

Plazo: Baseline (pre-intervention)

Less than 20% of participants are ineligible due to each criterion

Feasibility of randomization

Plazo: Pre-intervention

70% or more of participants are randomized and complete the first intervention session

Feasibility of the OM-OM intervention

Plazo: Duration of intervention

70% or more of participants attend all sessions and complete all homework

Feasibility of research assessments

Plazo: 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

Plazo: Baseline; 12-week follow-up

70% of more are collected

Acceptability of OM-OH intervention

Plazo: 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

Plazo: 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

Plazo: 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

Medidas secundarias

Five Factor Mindfulness Questionnaire (FFMQ)

Plazo: 0 and 12-weeks post-intervention

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.

Patient Health Questionnaire - 9 (PHQ-9)

Plazo: 0 and 12-weeks post-intervention

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.

Generalized Anxiety Disorder - 7 (GAD-7)

Plazo: 0 and 12-weeks post-intervention

GAD-7 assesses anxiety symptoms. Total scores of 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety symptoms, respectively.

Perceived Stress Scale (PSS)

Plazo: 0 and 12-weeks post-intervention

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.

HIV/AIDS Stress Scale

Plazo: 0 and 12-weeks post-intervention

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.

Alcohol Use Disorder Identification Test - Concise (AUDIT-C)

Plazo: 0 and 12-weeks post-intervention

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.

Physical Activity and Sedentary Behavior Questionnaire (PASBQ)

Plazo: 0 and 12-weeks post-intervention

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.

Dietary Risk Assessment (DRA)

Plazo: 0 and 12-weeks post-intervention

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.

Fagerstrom Test For Nicotine Dependence (FTND)

Plazo: 0 and 12-weeks post-intervention

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.

Inflammation Biomarkers

Plazo: 0- and 12-weeks post-intervention

Interleukin-6 and C-reactive protein measured in picograms per milliliter of blood

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

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Centros de investigación (1)

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1 centros

Massachusetts General HospitalBoston, Massachusetts, United StatesReclutando
Jacklyn Foley, PhDCONTACT
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Equipo y fechas

Patrocinador principal
Massachusetts General Hospital
Inicio del estudio
21 jul 2025 Real
Finalización primaria
30 jun 2028 Estimado
Finalización del estudio
31 ago 2028 Estimado
Primera publicación
21 ago 2023 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

Jacklyn Foley, PhDCONTACTjdfoley@mgh.harvard.edu857-347-5312
Título oficial del estudio

Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026