Chronic Stress, Hypertension (HTN)
Conditions
Brief summary
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.
Interventions
BEHAVIORALBehavioral: B-MORE (Brief Mindfulness-Oriented Recovery Enhancement)
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.
Sponsors
Florida State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 * Having self-reported hypertension (BP ≥ 140/90) * Understanding English or Spanish instructions fluently
Exclusion criteria
* Known or planned pregnancy in the next 3 months assessed via self-report * Cognitive impairment preventing completion of study procedures. * Have previous, formal mindfulness training (e.g., MBSR) * Other unstable illness judged by medical staff to interfere with study involvement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the B-MORE intervention for Stress | The expected time frame is from baseline to study completion, an average of 10 weeks. | 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. |
| Feasibility of the B-MORE intervention for Blood Pressure | The expected time frame is from baseline to study completion, an average of 10 weeks. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Acceptability for the B-MORE intervention for Stress | 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). | 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. |
| Treatment Acceptability for the B-MORE intervention for Blood Pressure | 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). | 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. |
| Treatment Expectancy for the B-MORE Intervention | Measured through participant self-report at the completion of the B-MORE program (immediately post-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. |
| Treatment Satisfaction with the B-MORE Intervention | 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). | 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. |
Countries
United States
Outcome results
None listed