Mindfulness-Based Intervention for Cardiovascular Health in Older Adults with HIV
(OM-OH Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Massachusetts General Hospital
Must be taking: Antiretrovirals
Disqualifiers: Non-English, Cognitive impairments, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests a new program called 'One Mind One Heart' (OM-OH) that uses mindfulness and behavior change techniques sent via text messages. It aims to help older people with HIV who are stressed and at risk for heart disease. The program hopes to reduce stress and inflammation, improving heart health.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the treatment One Mind One Heart (OM-OH) for cardiovascular health in older adults with HIV?
Research shows that mindfulness-based interventions, like the One Mind One Heart treatment, can help reduce stress and improve emotional well-being in people living with HIV. Additionally, yoga, a component of mindfulness practices, has been shown to lower blood pressure in HIV-infected adults with cardiovascular risk factors.
12345Is mindfulness-based intervention safe for people with HIV?
Mindfulness-based interventions, like Mindfulness-Based Stress Reduction (MBSR), have been studied in people with HIV and are generally considered safe. These interventions have shown benefits in reducing stress and improving emotional well-being without reported safety concerns.
12467How is the One Mind One Heart treatment different from other treatments for cardiovascular health in older adults with HIV?
The One Mind One Heart treatment is unique because it focuses on mindfulness-based interventions, which aim to reduce stress and improve emotional well-being, potentially benefiting cardiovascular health. Unlike standard medical treatments, this approach emphasizes mental and emotional health as a way to support physical health in people living with HIV.
12348Eligibility Criteria
This trial is for people over 50 with HIV who have controlled viral loads and are experiencing psychological distress. They must also have at least one risk factor for heart disease, like diabetes or high blood pressure, and be able to receive text messages on their cell phone.Inclusion Criteria
Current elevated psychological distress (score ≥10 on 10-item Kessler Psychological Distress Scale [K10] screener)
I am 50 years old or older.
I have at least one risk factor for heart disease, like diabetes, smoking, high blood pressure, or high cholesterol.
+3 more
Exclusion Criteria
I am able to understand and give informed consent.
Untreated or under-treated serious mental illness (i.e., psychosis and bipolar disorder) based on clinical interview
I do not speak English.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Open Pilot
An open pilot with exit interviews and pre-post self-report assessments to inform the initial acceptability of OM-OH
4 weeks
Weekly visits (in-person or virtual)
Pilot Randomized Controlled Trial (RCT)
A pilot RCT to evaluate feasibility and acceptability of OM-OH compared to enhanced usual care
12 weeks
Bi-weekly visits (in-person or virtual)
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 weeks
2 visits (in-person)
Participant Groups
The 'One Mind One Heart' (OM-OH) program combines mindfulness and behavior change techniques delivered via text message to help reduce stress and lower the risk of heart disease in older adults with HIV. The study will compare OM-OH's effectiveness against standard care.
2Treatment groups
Experimental Treatment
Active Control
Group I: One-Mind One-HeartExperimental Treatment1 Intervention
One-Mind One-Heart (OM-OH) is intended to be a mindfulness-based, behavior change intervention to reduce psychological and behavioral cardiovascular disease risk.
Group II: EducationActive Control1 Intervention
The education session will provide information on behaviors important for cardiovascular disease risk reduction.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
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Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Yoga lifestyle intervention reduces blood pressure in HIV-infected adults with cardiovascular disease risk factors. [2021]People living with HIV infection are at increased risk for developing cardiovascular disease (CVD). Safe and effective interventions for lowering CVD risk in HIV infection are high priorities. We conducted a prospective, randomized, controlled study to evaluate whether a yoga lifestyle intervention improves CVD risk factors, virological or immunological status, or quality of life (QOL) in HIV-infected adults relative to standard of care treatment in a matched control group.
Mindfulness-based stress reduction for people living with HIV/AIDS: preliminary review of intervention trial methodologies and findings. [2018]In the context of successful antiretroviral therapy (ART) for the management of HIV infection, the harmful effects of stress remain a significant threat. Stress may increase viral replication, suppress immune response, and impede adherence to ART. Stressful living conditions of poverty, facing a chronic life-threatening illness and stigma all exacerbate chronic stress in HIV-affected populations. Stress-reduction interventions are urgently needed for the comprehensive care of people living with HIV. Mindfulness-based stress reduction (MBSR) is one approach that has shown promise as an intervention for patients facing other medical conditions for reducing disease progression, psychological distress and maladaptive behaviours. In this systematic review, we identified 11 studies that have examined MBSR as an intervention for HIV-positive populations. Of the studies, six were randomised designs, one was a quasi-experimental design, and the remaining four were pre- and post-test designs. The preliminary outcomes support MBSR to decrease emotional distress with mixed evidence for impact on disease progression. Effect sizes were generally small to moderate in magnitude. The early findings from this emerging literature must be considered preliminary and support moving forward with more rigorous controlled trials, evaluated with objective assessments in longer-term follow-ups to determine the efficacy of MBSR for people living with HIV.
Telephone-Delivered Mindfulness Training to Promote Medication Adherence and Reduce Sexual Risk Behavior Among Persons Living with HIV: An Exploratory Clinical Trial. [2022]This study explored whether telephone-delivered mindfulness training (MT) to promote medication adherence and reduce sexual risk behavior was feasible for and acceptable to people living with HIV. Participants (N = 42; 50% female; M age = 47.5 years) were randomized to MT or health coaching (HC). Pre- and post-intervention, and at 3-month follow-up, we assessed adherence to ART, sexual risk behavior, and hypothesized mediators; we also conducted individual interviews to obtain qualitative data. Results showed that 55% of patients assigned to MT completed ≥ 50% of the training calls compared with 86% of HC patients (p
Effectiveness of Mindfulness-Based Cognitive Therapy on the Quality of Life, Emotional Status, and CD4 Cell Count of Patients Aging with HIV Infection. [2019]Long-term diagnosed and treated HIV-infected patients have to cope with a wide range of challenges that threaten their ability to age successfully. We report the results of a randomized controlled trial testing the effects of a mindfulness-based cognitive therapy (MBCT) program on quality of life (QoL), emotional status, and immune status over a 3-month period. Forty HIV-infected patients diagnosed prior to 1996 and on cART for a minimum of 5 years were randomized to follow an MBCT program (n = 20) or remain as controls (routine follow-up) (n = 20). A regression analysis was performed, and the measurement of effect size was estimated using Cohen's d. QoL, psychological stress, depressive symptoms, and anxiety symptoms improved in the MBCT group compared with the control group. During follow-up, patients in the MBCT group had a significantly increased CD4 cell count. Effect sizes for MBCT on the variables assessed were large (d = 0.8). The findings suggest that this program may help to promote successful aging in these patients.
Effect of Yoga on Antiretroviral Adherence Postincarceration in HIV+ Individuals. [2023]The negative impacts of stress on antiretroviral therapy (ART) adherence and the many stressors faced by people returning from incarceration support the need for stress reduction interventions for this population. We hypothesized that 37 returning citizens living with HIV and substance use problems randomized to a 12-session weekly yoga intervention would experience improved ART adherence, lower viral loads, and lower heart rate and blood pressure as compared to 36 people randomized to treatment as usual (TAU). We found that ART adherence increased for yoga participants and decreased for TAU participants. There were no significant changes for viral load, heart rate, or blood pressure. The lack of statistically significant effects may be due to a small sample size and enrollment of people largely in HIV treatment. Studies with larger sample sizes and participants exhibiting low ART adherence are warranted to better understand yoga's impact.
Mindfulness meditation training effects on CD4+ T lymphocytes in HIV-1 infected adults: a small randomized controlled trial. [2021]Mindfulness meditation training has stress reduction benefits in various patient populations, but its effects on biological markers of HIV-1 progression are unknown. The present study tested the efficacy of an 8-week Mindfulness-based stress reduction (MBSR) meditation program compared to a 1-day control seminar on CD4+ T lymphocyte counts in stressed HIV infected adults. A single-blind randomized controlled trial was conducted with enrollment and follow-up occurring between November 2005 and December 2007. A diverse community sample of 48 HIV-1 infected adults was randomized and entered treatment in either an 8-week MBSR or a 1-day control stress reduction education seminar. The primary outcome was circulating counts of CD4+ T lymphocytes. Participants in the 1-day control seminar showed declines in CD4+ T lymphocyte counts whereas counts among participants in the 8-week MBSR program were unchanged from baseline to post-intervention (time x treatment condition interaction, p=.02). This effect was independent of antiretroviral (ARV) medication use. Additional analyses indicated that treatment adherence to the mindfulness meditation program, as measured by class attendance, mediated the effects of mindfulness meditation training on buffering CD4+ T lymphocyte declines. These findings provide an initial indication that mindfulness meditation training can buffer CD4+ T lymphocyte declines in HIV-1 infected adults.
The application of mindfulness for individuals living with HIV in South Africa: A hybrid effectiveness-implementation pilot study. [2020]Despite the recent growth of mindfulness research worldwide, there remains little research examining the application of mindfulness-based interventions in resource-limited, international settings. This study examined the application of Mindfulness Based Stress Reduction (MBSR) for HIV-infected individuals in South Africa, where rates of HIV are highest in the world. Mixed methods were used to examine the following over a three-month follow up: (1) feasibility, acceptability, and preliminary adaptation of MBSR for this new context; and (2) effects of MBSR on immune functioning, self-reported mindfulness (MAAS, FFMQ), depression, anxiety, and stress (DASS-21). Ten individuals initiated MBSR, and seven completed all eight sessions. Results indicated medium effect size improvements in immune functioning (CD4 count and t-cell count; d = .5) through the three-month follow up, though the small sample size limited power to detect a statistically significant effect. From baseline to post-treatment, improvements in "Observing" and "Non-reactivity" (FFMQ) approached statistical significance with large effect sizes (observing: d = 1.5; p = .08; non-reactivity: d = .7; p = .07). There were no statistically significant changes in depression, anxiety, or stress throughout the study period. Primary areas for adaptation of MBSR included emphasis on informal practice, ways to create "space" without much privacy, and ways to concretize the concepts and definitions of mindfulness. Feedback from participants can shape future adaptations to MBSR for this and similar populations. Findings provide preliminary evidence regarding the implementation of MBSR for individuals living with HIV in South Africa. A future randomized clinical trial with a larger sample size is warranted.
Mindfulness-Based Interventions for Adults Living with HIV/AIDS: A Systematic Review and Meta-analysis. [2023]This meta-analysis examined the effects of mindfulness-based interventions (MBIs) on stress, psychological symptoms, and biomarkers of disease among people living with HIV/AIDS (PLWHA). Comprehensive searches identified 16 studies that met the inclusion criteria (N = 1059; M age = 42 years; 20% women). Participants had been living with HIV for an average of 8 years (range =