Mechanisms of Mindfulness Training and Stress Reduction
30. januar 2017 opdateret af: Carnegie Mellon University
This study is a three-arm randomized controlled trial of a mindfulness stress reduction intervention, with the aim of dismantling the experience-monitoring and nonjudgmental-acceptance elements of mindfulness programs to determine the active treatment component.
In addition to enhancing understanding of mechanisms underlying the effects of mindfulness interventions, identifying the therapeutic constituent(s) could inform development of targeted interventions as well as provide strategies to optimize adherence.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
There is a growing body of randomized controlled trial (RCT) evidence indicating that mindfulness training interventions may reduce stress and improve stress-related disease outcomes.
Yet little is known about the underlying active training mechanisms of mindfulness training.
Although it is generally believed that mindfulness training interventions foster a capacity to monitor and accept present moment experience, debate currently focuses on whether it is the capacity to both monitor and non-judgmentally accept experience that drives the salutary effects observed in mindfulness training interventions.
This project will test these putative active mechanisms by comparing two different types of mindfulness meditation training programs.
N=135 stressed community adults will be recruited and randomized to either two different types of 8-week Mindfulness-Based Stress Reduction (MBSR) programs or a No Treatment Control (assessment only) comparison condition.
Participants will complete 3 days of daily experience sampling (Ecological Momentary Assessment) immediately before and after the 8-week intervention period to measure attentional control and stress perceptions in daily life.
In order to measure psychological and HPA-axis stress reactivity to a controlled stressor, participants will also complete a standardized acute stress challenge task (the Trier Social Stress Test, TSST) immediately following the 3-day post-intervention assessment period.
This project provides the first dismantling study of mindfulness meditation training, it utilizes cutting-edge daily experience sampling of real life stress (using EMA) and stress biomarkers (salivary cortisol), and will provide important initial information for designing more effective (and efficient) mindfulness training interventions in at-risk stressed patient populations.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
137
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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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Carnegie Mellon University
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Pittsburgh, Pennsylvania, Forenede Stater, 15232
- University of Pittsburgh Medical Center- Center for Integrative Medicine
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University Park, Pennsylvania, Forenede Stater, 16802
- Pennsylvania State University
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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 til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- English speaking
- Moderate- to high-stress
- Owns an internet-enabled smart phone
Exclusion Criteria:
- Diagnosis of chronic mental (e.g. recurrent depression, schizophrenia, personality disorder) or physical disease (e.g. cancer, HIV, diabetes)
- Hospitalization in past 3 months
- Medication use that interferes with cortisol activity (e.g. corticosteroids)
- Current oral contraceptive use
- Pregnancy
- Current antibiotic, antiviral, or antimicrobial treatment
- Travel outside the country within the past 6 months to any country on the Center for Disease Control travel alert list
- Recreational drug use, excessive alcohol or tobacco use
- Significant experience with or daily practice of mindfulness meditation or related mind-body practice
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Mindfulness Training
Mindfulness training intervention consisting of eight weekly 2.5 hour group sessions, a day-long retreat in the sixth week, and daily home mindfulness meditation
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Mindfulness training practices aim to foster attention and acceptance toward one's present moment experience.
Mindfulness consists of two components-- (1) deploying attention to monitor one's moment-to-moment experience, and (2) fostering an attitude of acceptance toward one's moment-to-moment experience
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Aktiv komparator: Mindful Attention Only Training
Mindful attention only training intervention consisting of eight weekly 2.5 hour group sessions, a day-long retreat in the sixth week, and daily home mindfulness meditation
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Mindfulness training practices aim to foster attention and acceptance toward one's present moment experience.
Mindfulness consists of two components-- (1) deploying attention to monitor one's moment-to-moment experience, and (2) fostering an attitude of acceptance toward one's moment-to-moment experience
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Ingen indgriben: No Treatment Control Condition
No treatment participants will be informed that their participation is important and that they are requested to not seek out similar treatments during this waiting period.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Daily life stress assessed via Ecological Momentary Assessment
Tidsramme: change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
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change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Daily life state attention and acceptance assessed via Ecological Momentary Assessment
Tidsramme: change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
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change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
|
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Subjective stress in response to social evaluative threat
Tidsramme: assessed at post-intervention, which is an average of 14 weeks
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assessed at post-intervention, which is an average of 14 weeks
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Salivary Cortisol in response to social evaluative threat
Tidsramme: assessed at post-intervention, which is an average of 14, at time 0, and 25, 35, and 60 minutes post-stress challenge
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assessed at post-intervention, which is an average of 14, at time 0, and 25, 35, and 60 minutes post-stress challenge
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Blood Pressure reactivity to social evaluative threat (systolic and diastolic blood pressure)
Tidsramme: assessed at post-intervention, which is an average of 14 weeks, at 2-minute intervals during session
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assessed at post-intervention, which is an average of 14 weeks, at 2-minute intervals during session
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Sustained attention measured by the Dichotic Listening Task
Tidsramme: change from baseline to post-intervention, which is an average of 14 weeks
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change from baseline to post-intervention, which is an average of 14 weeks
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Sustained inattentional blindness measured by the Inattentional Blindness Task
Tidsramme: post-intervention only
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post-intervention only
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Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Daily life affect assessed via Ecological Momentary Assessment
Tidsramme: change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
|
change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
|
|
Daily life social interactions assessed via Ecological Momentary Assessment
Tidsramme: change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
|
change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
|
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Perceived stress using the Perceived Stress Scale
Tidsramme: change from baseline to post-intervention, which is an average of 14 weeks
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change from baseline to post-intervention, which is an average of 14 weeks
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Attentional control using the Attentional Control Scale
Tidsramme: change from baseline to post-intervention, which is an average of 14 weeks
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change from baseline to post-intervention, which is an average of 14 weeks
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Treatment expectancies
Tidsramme: post-intervention an average of 14 weeks after the baseline
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post-intervention an average of 14 weeks after the baseline
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Subjective responses to the training program intervention
Tidsramme: composite of ratings made after each intervention lesson, an average of 10 weeks following baseline
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composite of ratings made after each intervention lesson, an average of 10 weeks following baseline
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Mindfulness using the Mindful Attention Awareness Scale
Tidsramme: change from baseline to post-intervention, which is an average of 14 weeks
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change from baseline to post-intervention, which is an average of 14 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Wendy Weber, Ph.D., National Center for Complementary and Integrative Health, National Institutes of Health
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
- Chin B, Lindsay EK, Greco CM, Brown KW, Smyth JM, Wright AGC, Creswell JD. Mindfulness interventions improve momentary and trait measures of attentional control: Evidence from a randomized controlled trial. J Exp Psychol Gen. 2021 Apr;150(4):686-699. doi: 10.1037/xge0000969. Epub 2020 Sep 24.
- Chin B, Lindsay EK, Greco CM, Brown KW, Smyth JM, Wright AGC, Creswell JD. Psychological mechanisms driving stress resilience in mindfulness training: A randomized controlled trial. Health Psychol. 2019 Aug;38(8):759-768. doi: 10.1037/hea0000763. Epub 2019 May 23.
- Lindsay EK, Chin B, Greco CM, Young S, Brown KW, Wright AGC, Smyth JM, Burkett D, Creswell JD. How mindfulness training promotes positive emotions: Dismantling acceptance skills training in two randomized controlled trials. J Pers Soc Psychol. 2018 Dec;115(6):944-973. doi: 10.1037/pspa0000134.
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. juli 2015
Primær færdiggørelse (Faktiske)
1. januar 2017
Studieafslutning (Faktiske)
1. januar 2017
Datoer for studieregistrering
Først indsendt
7. juli 2015
Først indsendt, der opfyldte QC-kriterier
16. juli 2015
Først opslået (Skøn)
20. juli 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
1. februar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. januar 2017
Sidst verificeret
1. januar 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1R21AT008493-01A1 (U.S. NIH-bevilling/kontrakt)
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 .