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Behavioural Intervention

Mindfulness-Based Intervention for Cardiovascular Health in Older Adults with HIV (OM-OH Trial)

N/A

Recruiting

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; 12-week follow-up

Awards & highlights

OM-OH Trial Summary

This trial aims to use evidence-based protocols to develop a new text message-enhanced intervention to reduce CVD risk in older people with HIV. The intervention will be tested for feasibility and acceptability, and its potential to reduce psychological distress, inflammation, and CVD risk.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this intervention involves mindfulness practices and education without medications, side effects may be minimal but could include discomfort from confronting personal issues during the process.

OM-OH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 and 12-weeks post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 and 12-weeks post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 and 12-weeks post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of OM-OH intervention

Acceptability of blood draws

Acceptability of text-enhanced delivery

+6 more

Secondary outcome measures

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

Dietary Risk Assessment (DRA)

Fagerstrom Test For Nicotine Dependence (FTND)

+7 more

OM-OH Trial Design

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,840 Previous Clinical Trials

47,852,074 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,935 Previous Clinical Trials

13,198,591 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate number of participants engaged in this investigation?

"Affirmative. According to clinicaltrials.gov, this experiment is currently enlisting participants and was first posted on September 1st 2023 before being amended on October 17th 2023. 50 individuals will be welcomed from one single medical site."

Answered by AI

Are medical personnel currently signing up participants for this clinical experiment?

"Affirmative. Clinicaltrials.gov reveals that the trial, which was initially published on September 1st 2023 and modified recently on October 17th 2023, is actively looking for participants. There are 50 openings at one particular site."

Answered by AI

What positive results are expected to come from this trial?

"This trial, which will be monitored over a 0 day intervention period and 12-week follow up duration, aims to evaluate the feasibility of obtaining blood samples. Secondary outcomes include Five Factor Mindfulness Questionnaire (FFMQ), Patient Health Questionnaire - 9 (PHQ-9) and Generalized Anxiety Disorder - 7 (GAD-7). FFMQ is used to measure trait mindfulness across five sub scales: observing, describing, acting with awareness, non-judging, and nonreactivity; PHQ-9 assesses depressive symptoms at different levels from mild to severe; GAD-7 evaluates anxiety intensity ranging from minor to substantial"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Jacklyn D. Foley, Ph.D 2023. "Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06001814.