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Mechanisms of Mindfulness Training and Stress Reduction

30 gennaio 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

137

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

  • Stati Uniti
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stati Uniti, 15213
        • Carnegie Mellon University
      • Pittsburgh, Pennsylvania, Stati Uniti, 15232
        • University of Pittsburgh Medical Center- Center for Integrative Medicine
      • University Park, Pennsylvania, Stati Uniti, 16802
        • Pennsylvania State University

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

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

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: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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
Comportamentale: Mindfulness
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
Comparatore attivo: 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
Comportamentale: Mindfulness
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
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Daily life stress assessed via Ecological Momentary Assessment
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Daily life state attention and acceptance assessed via Ecological Momentary Assessment
Lasso di tempo: 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
Subjective stress in response to social evaluative threat
Lasso di tempo: assessed at post-intervention, which is an average of 14 weeks
assessed at post-intervention, which is an average of 14 weeks
Salivary Cortisol in response to social evaluative threat
Lasso di tempo: assessed at post-intervention, which is an average of 14, at time 0, and 25, 35, and 60 minutes post-stress challenge
assessed at post-intervention, which is an average of 14, at time 0, and 25, 35, and 60 minutes post-stress challenge
Blood Pressure reactivity to social evaluative threat (systolic and diastolic blood pressure)
Lasso di tempo: assessed at post-intervention, which is an average of 14 weeks, at 2-minute intervals during session
assessed at post-intervention, which is an average of 14 weeks, at 2-minute intervals during session
Sustained attention measured by the Dichotic Listening Task
Lasso di tempo: change from baseline to post-intervention, which is an average of 14 weeks
change from baseline to post-intervention, which is an average of 14 weeks
Sustained inattentional blindness measured by the Inattentional Blindness Task
Lasso di tempo: post-intervention only
post-intervention only

Altre misure di risultato

Misura del risultato
Lasso di tempo
Daily life affect assessed via Ecological Momentary Assessment
Lasso di tempo: 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
Lasso di tempo: 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
Perceived stress using the Perceived Stress Scale
Lasso di tempo: change from baseline to post-intervention, which is an average of 14 weeks
change from baseline to post-intervention, which is an average of 14 weeks
Attentional control using the Attentional Control Scale
Lasso di tempo: change from baseline to post-intervention, which is an average of 14 weeks
change from baseline to post-intervention, which is an average of 14 weeks
Treatment expectancies
Lasso di tempo: post-intervention an average of 14 weeks after the baseline
post-intervention an average of 14 weeks after the baseline
Subjective responses to the training program intervention
Lasso di tempo: composite of ratings made after each intervention lesson, an average of 10 weeks following baseline
composite of ratings made after each intervention lesson, an average of 10 weeks following baseline
Mindfulness using the Mindful Attention Awareness Scale
Lasso di tempo: change from baseline to post-intervention, which is an average of 14 weeks
change from baseline to post-intervention, which is an average of 14 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Carnegie Mellon University

Collaboratori

University of Pittsburgh
Penn State University

Investigatori

  • Cattedra di studio: Wendy Weber, Ph.D., National Center for Complementary and Integrative Health, National Institutes of Health

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

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

1 luglio 2015

Completamento primario (Effettivo)

1 gennaio 2017

Completamento dello studio (Effettivo)

1 gennaio 2017

Date di iscrizione allo studio

Primo inviato

7 luglio 2015

Primo inviato che soddisfa i criteri di controllo qualità

16 luglio 2015

Primo Inserito (Stima)

20 luglio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

1 febbraio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 gennaio 2017

Ultimo verificato

1 gennaio 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1R21AT008493-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)

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 .

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