Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

MINDFUL-PC for Portuguese Speakers Pilot Study 2020

9. februar 2021 opdateret af: Cambridge Health Alliance

MINDFUL-PC for Portuguese Speakers Pilot #2 Study 2020 (Integrating Mindfulness Into the Patient-Centered Medical Home)

The study evaluates the effects of the Mindfulness Training for Primary Care (MTPC) Portuguese-adapted version on heart rate variability during a demanding cognitive task. The study also evaluates the effects on mental health, quality of life, self-regulation and behavior outcomes. The study will also complete the MTPC cultural adaptation process for Brazilian culture.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This single-arm, pre-post, non-randomized, unblinded, pilot trial evaluates the effects of Mindfulness Training for Primary Care (MTPC) Portuguese-adapted version on heart rate variability during a demanding cognitive task, i.e., Sustained Attention to Response Task (SART). Secondary aims are the following: 1) to measure pre/post outcomes for a) mental health (anxiety, depression, stress); b) quality of life; c) self-regulation (self-compassion, mindfulness, interoceptive awareness, difficulties in emotion regulation); and to determine the rate of d) chronic disease self-management action plan initiation; and 2) to complete the MTPC cultural adaptation for Brazilian culture through a) Satisfaction and Suggestions Survey; and b) Interviews of MTPC Group Leaders about their experience teaching the program Portuguese-adapted version.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Somerville, Massachusetts, Forenede Stater, 02143
        • Cambridge Health Alliance

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

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Current CHA patient with an enrolled CHA primary care doctor.
  • CHA patients 18 years of age and older.
  • Able to tolerate and participate in interviews and engage in all procedures.
  • Diagnosis eligible to be covered by insurance for group visits (e.g., anxiety disorder, depression, stress disorders including adjustment disorder related to chronic illness, pain, insomnia, etc.).
  • Must be able to fill out the study questionnaires on a computer or compatible mobile device.
  • Must be willing to attend the two computer task sessions.
  • Able to give written consent in Portuguese

Exclusion Criteria:

  • Any cognitive impairment that precludes informed consent.
  • Patients who, in the opinion of the Principal Investigator, pose an imminent risk of suicide or danger to self or others.
  • Likelihood of potential incarceration such as a conviction or pending charges that may potentially result in imprisonment.
  • Behaviors that may cause disruption to a mindfulness group.
  • Patients with symptoms of psychosis, thought disorder, and/or severe mental illness, including schizophrenia, schizoaffective, bipolar disorder, or a current severe episode of major depressive disorder.
  • Refusal of insurance to cover group psychotherapy treatment may lead to exclusion from participation in groups.
  • Patients in their third trimester of pregnancy who foresee conflicts that preclude their commitment to completing all activities.
  • Patients with highly unstable medical problems that put them at a high risk of hospitalization.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Mindfulness Training for Primary Care
Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers
Adfærdsmæssigt: Mindfulness træning for primærpleje
MTPC er et henvisningsbaseret, 8-ugers program, der refunderes af forsikring, leveret som gruppepsykoterapi af Patient-Centered Medical Home-integrerede adfærdsklinikere eller som et 8-ugers primært gruppebesøg leveret af en primær plejeudbyder. MTPC-grupper er 2 timer i 8 uger med en 7-timers weekenddag med stille praksis. MTPC lægger vægt på mindfulness-orienterede færdigheder til selvregulering, selvhåndtering af kronisk sygdom og sundhedsadfærdsændring. Alle deltagere udfylder en handlingsplan i løbet af uge 7. Deltagerne bliver kaldt hver anden uge i de første otte uger til 5-10 minutters engagementsopkald, som fokuserer på at hjælpe deltagerne med at opdyrke et forhold til studiepersonalet, give deltagerne et sted at stille spørgsmål og støtte deltagerne ved at gennemføre studiebesøg.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
High-Frequency power (HF) - Heart Rate Variability (HRV) during Sustained Attention to Response Task (SART) last 5 minutes
Tidsramme: Week 9
High-Frequency power (HF) - Heart Rate Variability (HRV) during Sustained Attention to Response Task (SART) last 5 minutes will be measured using Biostamp nPoint® medical device. During SART participants complete a computerized test measuring sustained attention and response inhibition. They are asked to press a key in response to rapidly displayed integers (1-9) and withhold a response to a designated "no-go" integer.
Week 9

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Perceived Stress Scale (PSS-14)
Tidsramme: Uge 8
Perceived Stress Scale (PSS-14) (14 punkter) måler i hvilken grad situationer i livet er stressende. Elementer er designet til at vurdere, hvor overbelastet, uforudsigeligt og ukontrollerbart man finder sit liv. Hvert emne bedømmes på en 5-punkts Likert-skala fra 0 (Aldrig) til 4 (Meget ofte).
Uge 8
Patientrapporterede udfaldsmålingsinformationssystem - Angst Short Form (PROMIS-ASF)
Tidsramme: Uge 8
Informationssystemet til måling af patientrapporterede resultater - Angst Short Form 8a (PROMIS-ASF) er en skala med 8 punkter, der bruges til at vurdere patientrapporteret helbredsstatus for angst. PROMIS-instrumenter er finansieret af National Institutes of Health (NIH) og bruges til pålideligt og validt at måle patientrapporterede resultater for klinisk forskning og praksis. Deltagerne bliver bedt om at vurdere deres oplevelse af emnet inden for de seneste syv dage på en 5-trins skala fra 1 (Aldrig) til 5 (Altid).
Uge 8
Patientrapporterede udfaldsmålingsinformationssystem - Depression Short Form (PROMIS-DSF)
Tidsramme: Uge 8
Informationssystemet til måling af patientrapporterede resultater - Depression Short Form 8a (PROMIS-DSF) er en skala med 8 punkter, der bruges til at vurdere patientrapporteret helbredsstatus for depression. PROMIS-instrumenter er finansieret af National Institutes of Health (NIH) og bruges til pålideligt og validt at måle patientrapporterede resultater for klinisk forskning og praksis. Deltagerne bliver bedt om at vurdere deres oplevelse af emnet inden for de seneste syv dage på en 5-trins skala fra 1 (Aldrig) til 5 (Altid).
Uge 8
Root Mean Square of the Successive Differences (RMSSD) - Heart Rate Variability (HRV) during Sustained Attention to Response Task (SART) last 5 minutes
Tidsramme: Week 9
Root Mean Square of the Successive Differences (RMSSD) - Heart Rate Variability (HRV) during Sustained Attention to Response Task (SART) last 5 minutes will be measured using Biostamp nPoint® medical device. During SART participants complete a computerized test measuring sustained attention and response inhibition. They are asked to press a key in response to rapidly displayed integers (1-9) and withhold a response to a designated "no-go" integer.
Week 9

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sværhedsgrad i Emotion Regulation Scale (DERS)
Tidsramme: Uge 8
Difficulties in Emotion Regulation (DERS)-skalaen er en 36-punkts selvrapporteringsskala designet til at vurdere følelsesmæssig dysregulering ved hjælp af en 5-punkts Likert-skala. Skalaen vurderer 6 aspekter af følelsesmæssig dysregulering: ikke-accept af følelsesmæssige reaktioner, vanskeligheder med at engagere sig i målrettet adfærd, impulskontrolvanskeligheder, mangel på følelsesmæssig bevidsthed, begrænset adgang til følelsesreguleringsstrategier og mangel på følelsesmæssig klarhed. Underskalaer summeres, og en lavere samlet score repræsenterer et bedre resultat.
Uge 8
Multidimensional vurdering af interoceptiv bevidsthed (MAIA)
Tidsramme: Uge 8
Multidimensional Assessment of Interoceptive Awareness (MAIA) er en 32-elements selvrapporteringsskala designet til at vurdere flere aspekter af interoception og interoceptiv bevidsthed. 6-punkts Likert-skalaen (spænder fra 0-6) vurderer 8 aspekter af interoceptiv bevidsthed: bemærke, ikke-distraherende, ikke-bekymrende, opmærksomhedsregulering, følelsesmæssig bevidsthed, selvregulering, kropslytning og tillid. Underskalaer er gennemsnittet, og en højere samlet score repræsenterer et bedre resultat.
Uge 8
Fem facetter mindfulness spørgeskema (FFMQ)
Tidsramme: Uge 8
The Five Facet Mindfulness Questionnaire (FFMQ) er en 39-element skala, der undersøger fem faktorer, der repræsenterer aspekter af den nuværende empiriske opfattelse af mindfulness. Disse fem facetter inkluderer: "at observere, beskrive, handle med bevidsthed, ikke-bedømme indre oplevelse og ikke-reaktivitet over for indre oplevelse." Deltagerne vurderer deres grad af overensstemmelse med hvert af punkterne på en Likert-skala, der spænder fra 1 (Aldrig eller meget sjældent sandt) til 5 (Meget ofte eller altid sandt), med højere score, der indikerer højere oplevelse af mindfulness.
Uge 8
High-Frequency power (HF) - Heart Rate Variability (HRV) during four 5-minute Sustained Attention to Response Task (SART) time blocks
Tidsramme: Week 9
High-Frequency power (HF) - Heart Rate Variability (HRV) during four 5-minute Sustained Attention to Response Task (SART) time blocks will be measured using Biostamp nPoint® medical device. During SART participants complete a computerized test measuring sustained attention and response inhibition. They are asked to press a key in response to rapidly displayed integers (1-9) and withhold a response to a designated "no-go" integer. Relationship between HF-HRV and SART performance will be evaluated and the effect of over time during the demanding SART task will also be evaluated.
Week 9
Root Mean Square of the Successive Differences (RMSSD) - Heart Rate Variability (HRV) during four 5-minute Sustained Attention to Response Task (SART) time blocks
Tidsramme: Week 9
Root Mean Square of the Successive Differences (RMSSD) - Heart Rate Variability (HRV) during four 5-minute Sustained Attention to Response Task (SART) time blocks will be measured using Biostamp nPoint® medical device. During SART participants complete a computerized test measuring sustained attention and response inhibition. They are asked to press a key in response to rapidly displayed integers (1-9) and withhold a response to a designated "no-go" integer. Relationship between RMSSD and SART performance will be evaluated and the effect of over time during the demanding SART task will also be evaluated.
Week 9
Action Plan Initiation Survey (APIS-5)
Tidsramme: Week 9
Patient self-reported Action Plan Initiation is based on two-item in the APIS-5 self-report survey in which patients are asked to list their action plan SMART goal, if they met the goal and how much control they had over meeting the goal. The main outcome is a single-item response determining whether they met or did not meet the goal using a 7-point Likert scale (ranging from 1-7) with scores >=5 representing self-reported initiation of the goal.
Week 9
World Health Organization Quality of Life- BREF (WHOQOL-BREF)
Tidsramme: Week 8
The World Health Organization has developed a quality of life instrument, the WHOQOL, which captures many subjective aspects of quality of life. The WHOQOL-BREF is a WHOQOL shorter version, comprises 26 items that produces scores for four domains related to quality of life: physical health, psychological, social relationships and environment. It also includes one facet on overall quality of life and general health.
Week 8
Self-Compassion Scale (SCS)
Tidsramme: Week 8
The Self-Compassion Scale is composed by 26 items measuring six components of self-compassion: self-kindness, self-judgment, common humanity, isolation, mindfulness and over-identification.The items are rated on a five-point response scale ranging from 1 (almost never) to 5 (almost always).
Week 8
Satisfaction Survey
Tidsramme: Week 8
Satisfaction Survey is an 18-item survey contains two parts. First is a series of 12 questions scored on a 5-point Likert scale from 1 (Strongly Disagree/Poor) to 5 (Strongly Agree/Excellent), with statements such as "I found this program helpful." Next is a series of six open-ended questions in which patients enter a written response to statements including "The most important thing I learned during this program."
Week 8
Suggestions Survey
Tidsramme: Week 8
The Suggestions Survey consist of 4 questions focusing on the intervention cultural aspects.
Week 8

Samarbejdspartnere og efterforskere

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

Sponsor

Cambridge Health Alliance

Samarbejdspartnere

National Center for Complementary and Integrative Health (NCCIH)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

21. januar 2020

Primær færdiggørelse (Faktiske)

10. april 2020

Studieafslutning (Faktiske)

10. april 2020

Datoer for studieregistrering

Først indsendt

11. februar 2020

Først indsendt, der opfyldte QC-kriterier

11. februar 2020

Først opslået (Faktiske)

13. februar 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. februar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. februar 2021

Sidst verificeret

1. februar 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CambridgeHA
  • UH3AT009145 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Depression

Kliniske forsøg med Mindfulness træning for primærpleje

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Benin

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner