Dual-Language B-MORE for Hypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFlorida State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18
Having self-reported hypertension (BP ≥ 140/90)
Understanding English or Spanish instructions fluently
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Behavioral: B-MORE (Brief Mindfulness-Oriented Recovery Enhancement)
BehavioralB-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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: B-MORE (Brief Mindfulness-Oriented Recovery Enhancement)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
The expected time frame is from baseline to study completion, an average of 10 weeks.2
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.
Time frame
The expected time frame is from baseline to study completion, an average of 10 weeks.Secondary outcomes
1
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.
Time frame
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).2
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.
Time frame
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).3
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.
Time frame
Measured through participant self-report at the completion of the B-MORE program (immediately post-intervention).4
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.
Time frame
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).Other outcomes
1
Change in Psychological Stress (Physiological)
Physiological data, including heart rate variability (HRV) collected via Garmin watches.
Time frame
Expected time frame is baseline to study completion, approximately 10 weeks. Heart rate and stress-related measures recorded daily.2
Adverse Effects of the B-MORE Intervention
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.
Time frame
Measured through participant self-report at the completion of the B-MORE program (immediately post-intervention).3
Change in Diastolic Blood Pressure
Self-measured diastolic blood pressure using a provided blood pressure cuff.
Time frame
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.4
Change in Systolic Blood Pressure
Self-measured systolic blood pressure using a provided blood pressure cuff.
Time frame
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.Sponsors and contacts
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Source ClinicalTrials.gov
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