Dual-Language B-MORE for Hypertension
31 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Actif, ne recrute pas
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
20
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Florida
-
Orlando, Florida, États-Unis, 32805
- Shepherd's Hope Downtown Clinic
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Feasibility of the B-MORE intervention for Stress
Délai: 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
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Treatment Acceptability for the B-MORE intervention for Stress
Délai: 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
Délai: 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
Délai: 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
Délai: 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).
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Psychological Stress (Physiological)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
5 juin 2026
Achèvement primaire (Estimé)
1 novembre 2026
Achèvement de l'étude (Estimé)
1 décembre 2026
Dates d'inscription aux études
Première soumission
5 mai 2026
Première soumission répondant aux critères de contrôle qualité
1 juin 2026
Première publication (Réel)
3 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
2 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
31 août 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY00007273 Shepherd's Hope
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Individual participant data will be shared with qualified individuals upon request.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .