Trials / Completed
CompletedNCT02657382
Mental Stress Ischemia: Biofeedback Study
Effects of Biofeedback on Myocardial Blood Flow Changes During Mental Stress in Patients With Coronary Artery Disease
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Emory University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the blood flow to the heart during stress and assess changes in blood flow after psychological treatment in participants with coronary artery disease. The aims of the study are to assess the effects of heart rate variability (HRV) biofeedback (versus usual care) on global and regional myocardial blood flow (MBF), peripheral vascular function, and autonomic changes during mental stress.
Detailed description
The purpose of this study is to evaluate the blood flow to the heart during stress and assess changes in blood flow after psychological treatment in participants with coronary artery disease. This is a randomized controlled study. The aims of the study are to assess the effects of heart rate variability (HRV) biofeedback (versus usual care) on global and regional myocardial blood flow (MBF), peripheral vascular function, and autonomic changes during mental stress. All participants will undergo myocardial flow/perfusion imaging with positron emission tomography (PET) imaging at rest and after a standardized arithmetic mental stress test. Participants will then undergo repeat testing after 6 weeks. At 12 weeks, participants will also undergo a limited examination without myocardial perfusion imaging. The intervention group will receive biofeedback after enrollment, and the wait-list control group will receive the intervention between week 6 and week 12 study visits (without imaging).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Heart Rate Variability (HRV) Biofeedback (BF) | Heart Rate Variability (HRV) biofeedback involves deep breathing, mindfulness (focusing on one's emotions and thoughts) and cognitive therapy (identifying and changing unhelpful or inaccurate thinking and distressing emotional responses). It is a 6-week training with one hour sessions with a certified biofeedback coach once per week. A handheld personal stress reliever device will be provided to the patients to practice at home for 20 minutes a day. |
| OTHER | Mental Stress Protocol | Mental stress will consist of a 3-min math serial subtraction paradigm.The participants will be asked to serially subtract 7 from number specified by the researcher. For participants who have difficulty with this task, easier serial subtraction will be provided for. Throughout the task, to increase stressfulness and titrate difficulty, the participant will be prompted for faster performance and the starting number from which they were subtracting will be periodically changed. Finally, to add an evaluation component, participants will be given negative feedback during the test. |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2020-06-24
- Completion
- 2020-06-24
- First posted
- 2016-01-15
- Last updated
- 2020-09-14
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02657382. Inclusion in this directory is not an endorsement.