- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02419430
Mindfulness Based Resilience Training (MBRT)
14. maj 2016 opdateret af: Cynthia M. Stonnington, M.D., Mayo Clinic
Mindfulness Based Resilience Training for Employees at Mayo Clinic
The investigators aim to evaluate the Mindfulness Based Resilience Training (MBRT) intervention for Mayo Clinic employees in order to provide evidence for improved ability to cope with stress and decreased work-related burnout and stress-related symptoms as a result of MBRT training.
In addition, the investigators aim to compare the effects of MBRT + smartphone sleep feedback, a smartphone resilience intervention + smartphone sleep feedback, or waitlist control +smartphone sleep feedback in a randomized clinical trial in a sample of 75 Mayo Clinic employees.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The investigators aim to compare the effects of MBRT + smartphone sleep feedback, a smartphone resilience intervention + smartphone sleep feedback, or waitlist control +smartphone sleep feedback in a randomized clinical trial in a sample of 75 Mayo Clinic employees.
Specific self-report outcomes include: well-being, stress, anxiety, depression, fatigue, resilience, self-compassion, and burn-out, assessed at pre-, post- and 3-month followup.
Objective outcomes, derived from smartphone-driven self-monitoring, include sleep quality and emotional experiencing, assessed throughout the six-week intervention period.
The investigators will explore whether changes in objectively measured sleep quality and emotional experiencing will mediate treatment effects on self-report outcomes.
The investigators will also explore whether treatment effects are more robust in self-selected versus randomized groups by drawing on the investigators' existing data.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Arizona
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Scottsdale, Arizona, Forenede Stater, 85259
- Mayo Clinic in Arizona
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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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion:
- Stress subscale of the DASS-21 needs to be a score 5 or greater and
- Must have a smart Phone, and
- Ability to attend at least 5 complete sessions.
Exclusion :
- Stress subscale of the DASS-21 less than 5.
- Must have a smart Phone.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: MBRT ClassRoom and Phone Application
|
2 hours/week for 6 week, in classroom intervention involving mindfulness based resilience training.focused
on mindfulness and self-compassion training, including body awareness, breath awareness, mindful movement, awareness of thoughts, and awareness of emotion.
Core concepts included: normalizing experience of stress and changing one's relationship with an experience; learning to be a compassionate observer of self in order to appreciate the moment; recognizing undue efforts to control something that has already happened; shifting attention to felt body sense and away from the narrative; and redirecting attention to a value as a way of evoking positive states that enhance the present moment experience.
Participants also use the smartphone to track their sleep and subjective well-being.
|
Aktiv komparator: Phone application only
|
Participants will track their sleep and subjective well-being and also choose one of the following weekly challenges, which is completed via smartphone interactions:
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Aktiv komparator: Questionnaires
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At baseline, immediately after the last MBRT session (6 weeks) and again at 3 and 6 months, all participants will complete questionnaires, including: 1) WHO-5 Well-Being Index; 2) DASS-21; 3) VAS-Fatigue; 4) MBI-Human Services version; 5) Self-Compassion Scale; 6) Connor-Davidson 2-item resilience scale; 7) Compassion to others scale.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Changes in scores using the DASS-21(Depression Anxiety and Stress Scales) questionnaire
Tidsramme: Baseline to 6 months
|
Baseline to 6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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
1. april 2015
Primær færdiggørelse (Faktiske)
1. marts 2016
Studieafslutning (Faktiske)
1. marts 2016
Datoer for studieregistrering
Først indsendt
14. april 2015
Først indsendt, der opfyldte QC-kriterier
16. april 2015
Først opslået (Skøn)
17. april 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. maj 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. maj 2016
Sidst verificeret
1. maj 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 15-001492
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 .