HARP Mindfulness Study for Cardiovascular Diseases
This study is exploring if adding extra support helps people with heart disease or heart disease risk factors manage stress, anxiety, and depression. It's testing two types of support: monthly "Booster Mindfulness Sessions" and a "Website Support" tool. These are added to an 8-week program called MBCT-T, which combines mindfulness and cognitive-behavioral therapy. You could join if you are 18 or older and have ischemic heart disease (a type of heart disease) without recent hospitalizations, or if you have risk factors for heart disease. The study will measure your stress, depression, and anxiety levels at the beginning, after the 8-week program, and again six months later. The current status of this study is unclear.
- Study design
- This is an interventional study planning to enroll 160 participants. It uses a specific design to see if extra support improves the main mindfulness program.
- What's involved
- You would participate in an 8-week group-based program, with weekly 1-hour sessions. Some participants will also have monthly 1-hour booster sessions for 4 months and access to a study website.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your stress, depression, and anxiety levels will be measured at the beginning, after the 8-week program (Month 2), and again at Month 6.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
HARP Mindfulness Study
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Tanya Spruill, PhD · PRINCIPAL_INVESTIGATOR · NYU Langone Health
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Composite Score of 3 Questionnaires: Perceived Stress Scale 10-item Version (PSS-10); Patient Health Questionnaire 9-Item Version (PHQ-9); and Generalized Anxiety Disorder Questionnaire 7-Item Version (GAD-7) at BaselineBaseline
Composite score of 3 questionnaires. The total composite score is the sum of scores from the questionnaires and ranges from 0 to 88; lower scores indicate greater overall health. PSS-10 measures perceived stress over the past month. Items rated on a 5-point scale ranging from 0 (never) to 4 (very often). Total scores range from 0-40; higher scores indicate greater levels of perceived stress. PHQ-9 assesses depressive symptoms in the past two weeks. Items rated on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Total scores range from 0-27 with recommended cutoffs for mild (5-9), moderate (10-14), moderately severe (15-19) and severe (≥20) depressive symptoms. GAD-7 measures anxiety symptoms in the past 2 weeks. Items rated on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Total scores range from 0-21 with recommended cutoffs for mild (5-9), moderate (10-14), and severe (15-21) anxiety.
- Composite Score of 3 Questionnaires: PSS-10; PHQ-9; and GAD-7 at Post-InterventionMonth 2
Composite score of 3 questionnaires. The total composite score is the sum of scores from the questionnaires and ranges from 0 to 88; lower scores indicate greater overall health. PSS-10 measures perceived stress over the past month. Items rated on a 5-point scale ranging from 0 (never) to 4 (very often). Total scores range from 0-40; higher scores indicate greater levels of perceived stress. PHQ-9 assesses depressive symptoms in the past two weeks. Items rated on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Total scores range from 0-27 with recommended cutoffs for mild (5-9), moderate (10-14), moderately severe (15-19) and severe (≥20) depressive symptoms. GAD-7 measures anxiety symptoms in the past 2 weeks. Items rated on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Total scores range from 0-21 with recommended cutoffs for mild (5-9), moderate (10-14), and severe (15-21) anxiety.
- Composite Score of 3 Questionnaires: PSS-10; PHQ-9; and GAD-7 at Follow-UpMonth 6
Composite score of 3 questionnaires. The total composite score is the sum of scores from the questionnaires and ranges from 0 to 88; lower scores indicate greater overall health. PSS-10 measures perceived stress over the past month. Items rated on a 5-point scale ranging from 0 (never) to 4 (very often). Total scores range from 0-40; higher scores indicate greater levels of perceived stress. PHQ-9 assesses depressive symptoms in the past two weeks. Items rated on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Total scores range from 0-27 with recommended cutoffs for mild (5-9), moderate (10-14), moderately severe (15-19) and severe (≥20) depressive symptoms. GAD-7 measures anxiety symptoms in the past 2 weeks. Items rated on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Total scores range from 0-21 with recommended cutoffs for mild (5-9), moderate (10-14), and severe (15-21) anxiety.