Dual-Language B-MORE for Hypertension
2026年8月31日 更新者: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.
調査の概要
状態
積極的、募集していない
研究の種類
介入
入学 (推定)
20
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Florida
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Orlando、Florida、アメリカ、32805
- Shepherd's Hope Downtown Clinic
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:他の
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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.
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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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Feasibility of the B-MORE intervention for Stress
時間枠:The expected time frame is from baseline to study completion, an average of 10 weeks.
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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.
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The expected time frame is from baseline to study completion, an average of 10 weeks.
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Feasibility of the B-MORE intervention for Blood Pressure
時間枠:The expected time frame is from baseline to study completion, an average of 10 weeks.
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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.
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The expected time frame is from baseline to study completion, an average of 10 weeks.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Treatment Acceptability for the B-MORE intervention for Stress
時間枠: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).
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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.
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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).
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Treatment Acceptability for the B-MORE intervention for Blood Pressure
時間枠: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).
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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.
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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).
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Treatment Expectancy for the B-MORE Intervention
時間枠:Measured through participant self-report at the completion of the B-MORE program (immediately post-intervention).
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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.
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Measured through participant self-report at the completion of the B-MORE program (immediately post-intervention).
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Treatment Satisfaction with the B-MORE Intervention
時間枠: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).
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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.
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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).
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Psychological Stress (Physiological)
時間枠:Expected time frame is baseline to study completion, approximately 10 weeks. Heart rate and stress-related measures recorded daily.
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Physiological data, including heart rate variability (HRV) collected via Garmin watches.
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Expected time frame is baseline to study completion, approximately 10 weeks. Heart rate and stress-related measures recorded daily.
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Adverse Effects of the B-MORE Intervention
時間枠:Measured through participant self-report at the completion of the B-MORE program (immediately post-intervention).
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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.
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Measured through participant self-report at the completion of the B-MORE program (immediately post-intervention).
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Change in Diastolic Blood Pressure
時間枠: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.
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Self-measured diastolic blood pressure using a provided blood pressure cuff.
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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.
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Change in Systolic Blood Pressure
時間枠: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.
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Self-measured systolic blood pressure using a provided blood pressure cuff.
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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.
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Change in State Anxiety
時間枠:Expected time frame is 2 weeks. Measured immediately before and after each of the 2 intervention sessions.
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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.
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Expected time frame is 2 weeks. Measured immediately before and after each of the 2 intervention sessions.
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Change in Trait Anxiety
時間枠: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.
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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.
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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.
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Change in Trait Depression
時間枠: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.
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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.
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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.
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Change in Quality of Life
時間枠: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.
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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.
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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.
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Change in Hypertension Symptomology
時間枠: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.
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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.
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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.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月5日
一次修了 (推定)
2026年11月1日
研究の完了 (推定)
2026年12月1日
試験登録日
最初に提出
2026年5月5日
QC基準を満たした最初の提出物
2026年6月1日
最初の投稿 (実際)
2026年6月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月2日
QC基準を満たした最後の更新が送信されました
2026年8月31日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。