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Dual-Language B-MORE for Hypertension

31. august 2026 opdateret af: 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.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Aktiv, ikke rekrutterende

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
20

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Studiesteder

  • Forenede Stater
    • Florida
      • Orlando, Florida, Forenede Stater, 32805
        • Shepherd's Hope Downtown Clinic

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: 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.
Adfærdsmæssigt: Behavioral: B-MORE (Brief Mindfulness-Oriented Recovery Enhancement)
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.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of the B-MORE intervention for Stress
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment Acceptability for the B-MORE intervention for Stress
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).

Andre resultatmål

Andre resultatmål

For kliniske forsøg en planlagt måling beskrevet i protokollen, der bruges til at bestemme effekten af ​​en intervention/behandling på deltagerne. Til observationsstudier, en måling eller observation, der bruges til at beskrive mønstre af sygdomme eller egenskaber eller sammenhænge med eksponeringer, risikofaktorer eller behandling. Typer af resultatmål omfatter primært resultatmål og sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Psychological Stress (Physiological)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Florida State University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
5. juni 2026

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
1. november 2026

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
1. december 2026

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
5. maj 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
1. juni 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
2. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
31. august 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • STUDY00007273 Shepherd's Hope

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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