이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Dual-Language B-MORE for Hypertension

2026년 8월 31일 업데이트: Adam Hanley, Florida State University

B-MORE for Hypertension

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.

연구 개요

연구 유형

중재적

등록 (추정된)

20

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Florida
      • Orlando, Florida, 미국, 32805
        • Shepherd's Hope Downtown Clinic

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: B-MORE (Brief Mindfulness-Oriented Recovery Enhancement)
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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Feasibility of the B-MORE intervention for Stress
기간: 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.
The expected time frame is from baseline to study completion, an average of 10 weeks.
Feasibility of the B-MORE intervention for Blood Pressure
기간: 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.
The expected time frame is from baseline to study completion, an average of 10 weeks.

2차 결과 측정

결과 측정
측정값 설명
기간
Treatment Acceptability for the B-MORE intervention for Stress
기간: 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.
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
기간: 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.
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
기간: 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.
Measured through participant self-report at the completion of the B-MORE program (immediately post-intervention).
Treatment Satisfaction with the B-MORE Intervention
기간: 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.
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).

기타 결과 측정

결과 측정
측정값 설명
기간
Change in Psychological Stress (Physiological)
기간: Expected time frame is baseline to study completion, approximately 10 weeks. Heart rate and stress-related measures recorded daily.
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
기간: Measured through participant self-report at the completion of the B-MORE program (immediately post-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.
Measured through participant self-report at the completion of the B-MORE program (immediately post-intervention).
Change in Diastolic Blood Pressure
기간: 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.
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
기간: 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.
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
기간: Expected time frame is 2 weeks. Measured immediately before and after each of the 2 intervention sessions.
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
기간: 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.
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
기간: 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.
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
기간: 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.
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
기간: 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.
Changes in hypertension symptomology will be based on the Mini Cuestionario de Calidad de Vida en Hipertensión 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 5일

기본 완료 (추정된)

2026년 11월 1일

연구 완료 (추정된)

2026년 12월 1일

연구 등록 날짜

최초 제출

2026년 5월 5일

QC 기준을 충족하는 최초 제출

2026년 6월 1일

처음 게시됨 (실제)

2026년 6월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 31일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • STUDY00007273 Shepherd's Hope

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Individual participant data will be shared with qualified individuals upon request.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다