Dual-Language B-MORE for Hypertension
31 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
20
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Florida
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Orlando, Florida, Stati Uniti, 32805
- Shepherd's Hope Downtown Clinic
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Feasibility of the B-MORE intervention for Stress
Lasso di tempo: 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
Lasso di tempo: 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.
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The expected time frame is from baseline to study completion, an average of 10 weeks.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Treatment Acceptability for the B-MORE intervention for Stress
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Psychological Stress (Physiological)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
5 giugno 2026
Completamento primario (Stimato)
1 novembre 2026
Completamento dello studio (Stimato)
1 dicembre 2026
Date di iscrizione allo studio
Primo inviato
5 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
1 giugno 2026
Primo Inserito (Effettivo)
3 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
2 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
31 agosto 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- STUDY00007273 Shepherd's Hope
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
Individual participant data will be shared with qualified individuals upon request.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .