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This pilot study is a single-arm clinical feasibility trial evaluating the feasibility, acceptability, and preliminary efficacy of a brief adaptation of Mindfulness-Oriented Recovery Enhancement (B-MORE) for reducing stress and high blood pressure in hypertensive English- and Spanish-speaking patients (n=20). The intervention, a 2-hour online training in stress management and hypertension, will be delivered virtually in a small-group format over two 60-minute sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B-MORE (Brief Mindfulness-Oriented Recovery Enhancement) | Experimental | Participants will receive a remotely-delivered mindfulness-based intervention (B-MORE) consisting of two 60-minute small group sessions conducted over two weeks. The intervention includes mindfulness training, cognitive reappraisal, and positive emotion regulation techniques. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral: B-MORE (Brief Mindfulness-Oriented Recovery Enhancement) | Behavioral | B-MORE is a validated, two-hour adaptation of the evidence-based MORE program. It retains each of the three, core therapeutic elements of the traditional MORE program (mindfulness, reappraisal, savoring) and is organized for delivery in two, 1-hour sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the B-MORE intervention for Stress | The feasibility of the B-MORE intervention for managing stress in hypertensive patients will be assessed using recruitment metrics. Specifically, feasibility will be based on the recruitment rate, defined as the number of participants recruited and enrolled per week. Feasibility will also be based on session attendance metrics, defined as the percentage of participants who complete the first B-MORE session and the second B-MORE session. Finally, feasibility will be based on retention rates, defined as the percentage of participants completing all treatment sessions and study surveys. | The expected time frame is from baseline to study completion, an average of 10 weeks. |
| Feasibility of the B-MORE intervention for Blood Pressure | The feasibility of the B-MORE intervention for managing blood pressure in hypertensive patients will be assessed using recruitment metrics. Specifically, feasibility will be based on the recruitment rate, defined as the number of participants recruited and enrolled per week. Feasibility will also be based on session attendance metrics, defined as the percentage of participants who complete the first B-MORE session and the second B-MORE session. Finally, feasibility will be based on retention rates, defined as the percentage of participants completing all treatment sessions and study surveys. | The expected time frame is from baseline to study completion, an average of 10 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Acceptability for the B-MORE intervention for Stress | The acceptability of the B-MORE intervention for managing stress in hypertensive patients will be based on participant self-report at the completion of the B-MORE program and at the 2- and 6-week follow-up assessments. More specifically, a 4-item Treatment Acceptability and Preferences questionnaire rated on a 5-point Likert Scale ("Not at all" to "Very Much") will be used for treatment acceptability. The scores from these 4 items will be summed and averaged to calculate an average score between 1 and 5, with a higher average scores indicating greater treatment acceptability. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Psychological Stress (Physiological) | Physiological data, including heart rate variability (HRV) collected via Garmin watches. | Expected time frame is baseline to study completion, approximately 10 weeks. Heart rate and stress-related measures recorded daily. |
| Adverse Effects of the B-MORE Intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam Hanley, PhD | Contact | 850-645-9557 | adam.hanley@fsu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shepherd's Hope Downtown Clinic | Orlando | Florida | 32805 | United States |
Individual participant data will be shared with qualified individuals upon request.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Measured through participant self-report at the completion of the B-MORE program (immediately post-intervention and at 2-week and 6-week follow-up assessments). |
| Treatment Acceptability for the B-MORE intervention for Blood Pressure | The acceptability of the B-MORE intervention for managing blood pressure in hypertensive patients will be based on participant self-report at the completion of the B-MORE program and at the 2- and 6-week follow-up assessments. More specifically, a 4-item Treatment Acceptability and Preferences questionnaire rated on a 5-point Likert Scale ("Not at all" to "Very Much") will be used for treatment acceptability. The scores from these 4 items will be summed and averaged to calculate an average score between 1 and 5, with a higher average scores indicating greater treatment acceptability. | Measured through participant self-report at the completion of the B-MORE program (immediately post-intervention and at 2-week and 6-week follow-up assessments). |
| Treatment Expectancy for the B-MORE Intervention | Treatment expectancy for the B-MORE intervention will be based on participant self-report at the completion of the B-MORE program and at the 2- and 6-week follow-up assessments. More specifically, a 4-item Credibility/Expectancy Questionnaire rated on a sliding scale from "Not at all" to "Very Much" will be used for treatment expectancy and credibility, with higher ratings indicating greater treatment expectancy. | Measured through participant self-report at the completion of the B-MORE program (immediately post-intervention). |
| Treatment Satisfaction with the B-MORE Intervention | Treatment satisfaction with the B-MORE intervention will be based on participant self-report at the completion of the B-MORE program and at the 2- and 6-week follow-up assessments. More specifically, a 3-item questionnaire with qualitative questions on the patient experience (e.g., "Was the program accessible? If not, what barriers did you encounter?" and "What were the best or most useful elements of the program?") will be used for treatment satisfaction. | Measured through participant self-report at the completion of the B-MORE program (immediately post-intervention and at the 2- and 6-week follow up points). |
Adverse effects of the B-MORE intervention will be based on participant self-report at the completion of the B-MORE program and at the 2- and 6-week follow-up assessments. More specifically, a 2-item measure on unwanted or unpleasant experiences during or after the training sessions (e.g., "Did you experience any unwanted or unpleasant experiences during or after the training?") will be used for evaluating adverse effects. |
| Measured through participant self-report at the completion of the B-MORE program (immediately post-intervention). |
| Change in Diastolic Blood Pressure | Self-measured diastolic blood pressure using a provided blood pressure cuff. | Measured at baseline, before and after each intervention session, immediately post-intervention, and at 2-week and 6-week follow-up assessments. Daily BP measurements will also be taken. |
| Change in Systolic Blood Pressure | Self-measured systolic blood pressure using a provided blood pressure cuff. | Measured at baseline, before and after each intervention session, immediately post-intervention, and at 2-week and 6-week follow-up assessments. Daily BP measurements will also be taken. |
| Change in State Anxiety | Changes in state anxiety will be based on a single-item self-report question on acute anxiety symptoms ("How nervous, anxious, or on edge do you feel right now?"). It will be rated on a 0-10 numeric rating scale, with 0 being no anxiety at all and 10 being anxiety as bad as you can imagine. It will be measured immediately before and immediately after the B-MORE sessions. | Expected time frame is 2 weeks. Measured immediately before and after each of the 2 intervention sessions. |
| Change in Trait Anxiety | Changes in trait anxiety will be based on the Generalized Anxiety Disorder-2, a 2-item questionnaire rated on 4-point Likert scale from "Not at all" to "Nearly every day." The scores from these 2 items will be summed to calculate a total score between 0 and 6, with higher scores (3 or higher) indicating greater anxiety symptoms. It will be completed at baseline, immediately post-intervention, and at the 2- and 6-week follow-up assessments. | Expected time frame is baseline to study completion, approximately 10 weeks. Measured at baseline, immediately post-intervention, and at 2-week and 6-week follow-up assessments. |
| Change in Trait Depression | Changes in trait depression will be based on the Depression with the Patient Health Questionnaire-2, a 2-item questionnaire rated on 4-point Likert scale from "Not at all" to "Nearly every day." The scores from these 2 items will be summed to calculate a total score between 0 and 6, with higher scores (3 or higher) indicating greater depression symptoms. It will be completed at baseline, immediately post-intervention, and at the 2- and 6-week follow-up assessments. | Expected time frame is baseline to study completion, approximately 10 weeks. Measured at baseline, immediately post-intervention, and at 2-week and 6-week follow-up assessments. |
| Change in Quality of Life | Changes in quality of life will be based on the WHO-5 Well-Being Index, a 5-item questionnaire rated on a 0-5 numeric rating scale, with 0 being "At no time" and 5 being "All of the time." The scores from all 5 items will be summed to calculate a raw score between 0 and 25 and then multiplied to calculate a percentage score between 0 and 100, with higher percentages indicating greater mental well-being. It will be completed at baseline, immediately post-intervention, and at the 2- and 6-week follow-up assessments. | Expected time frame is baseline to study completion, approximately 10 weeks. Measured at baseline, immediately post-intervention, and at 2-week and 6-week follow-up assessments. |
| Change in Hypertension Symptomology | Changes in hypertension symptomology will be based on the Mini Cuestionario de Calidad de Vida en HipertensiĆ³n Arterial (MINICHAL), a 16-item questionnaire rated on a 4-point Likert scale from "No, not at all" (0) to "Yes, a lot" (3). Scores from items 1-10 will be summed to calculate a total score for the State of Mind Domain. This total score will range from 0 to 30, with higher scores indicating worse mental well-being due to hypertension. Scores from items 11-16 will be summed to calculate a total score for the Somatic Manifestations Domain. This total score will range from 0 to 18, with higher scores indicating more severe physical symptoms due to hypertension. It will be completed at baseline, immediately post-intervention, and at the 2- and 6-week follow-up assessments. | Expected time frame is baseline to study completion, approximately 10 weeks. Measured at baseline, immediately post-intervention, and at 2-week and 6-week follow-up assessments. |