Dual-Language B-MORE for Hypertension

NCT07623031 | Not Yet Recruiting

• 1 other identifier: STUDY00007273 Shepherd's Hope
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension (HTN); Chronic Stress

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (4)

• 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).

• 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).

• Treatment Expectancy for the B-MORE Intervention

  Measured through participant self-report at the completion of the B-MORE program (immediately post-intervention).

• 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).

Other Outcomes (9)

• Change in Psychological Stress (Physiological)

  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

  Measured through participant self-report at the completion of the B-MORE program (immediately post-intervention).

• Change in Diastolic Blood Pressure

  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.

Study Arms (1)

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.

Behavioral: Behavioral: B-MORE (Brief Mindfulness-Oriented Recovery Enhancement)

Interventions

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.

B-MORE (Brief Mindfulness-Oriented Recovery Enhancement)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18
• Having self-reported hypertension (BP ≥ 140/90)
• Understanding English or Spanish instructions fluently

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Shepherd's Hope Downtown Clinic

Orlando, Florida, 32805, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Adam Hanley, PhD

CONTACT

850-645-9557; adam.hanley@fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)