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Dismantling Mindfulness: Contributions of Attention vs. Acceptance

1. november 2018 opdateret af: Willoughby Britton, Brown University

This study addresses NCCAM's request for research that investigates the neuropsychological mechanisms underlying mind-body therapies, and for precise criteria and better delineation of meditation practices.

The purpose of this study is to assess the clinical efficacy and mechanism of action of 2 component practices of "mindfulness meditation", i.e. focused awareness (FA) and open monitoring (OM) in comparison to each other and to the standard package, Mindfulness-Based Cognitive Therapy (MBCT).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Meditation, particularly mindfulness meditation, is one of the most popular Complementary and Alternative Medicine (CAM) therapies for alleviating emotional stress, depression and anxiety. While standardized meditation-based treatment packages like Mindfulness Based Stress Reduction (MBSR) and Mindfulness-based Cognitive Therapy (MBCT) have reliably shown sustained improvements in emotional disturbances and wellbeing, they contain so many different components and practices that the active ingredient cannot be ascertained. What is commonly called "Mindfulness" meditation is actually comprised of two separate practices: 1) focused awareness practice (FA), and 2) open-monitoring practice (OM). This project aims to create separate 8 week programs for FA and OM meditations, compare their clinical efficacy and investigate their separate mechanisms of action in individuals with clinically significant levels of persistent negative affect and depression. The clinical benefit and mechanism of action of focused awareness (FA) vs open-monitoring (OM) vs MBCT will be examined with a 3-armed randomized control trial of these 8 week interventions. Outcome variables include negative affect (depression, anxiety, stress) and wellbeing. Hypothesized mediating processes include objectively measured attention, emotion regulation and the basic wakefulness on which they depend.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

104

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
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02912
        • Brown University Clinical and Affective Neuroscience Laboratory

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 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • English-speaking
  • ages 18-65
  • mild-severe levels of depression or high level of negative affect

Exclusion Criteria:

  • Current:

    • age <18 or >65
    • inability to read and write in English
    • Extremely severe levels of depression
    • active suicidal ideation
    • presence of Axis I personality disorder
    • panic disorder
    • post-traumatic stress disorder
    • obsessive-compulsive disorder
    • eating disorder, or substance abuse/dependence
    • current psychotherapy
    • change in antidepressant medication type or dosage in the last 8 weeks.

Lifetime history exclusions:

  • bipolar disorder
  • psychotic disorders
  • persistent antisocial behavior or repeated self-harm,
  • borderline personality disorder,
  • organic brain damage
  • regular meditation 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: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Focused Attention (FA)
This 8 week program consists solely of focused attention practices, i.e. selected attention to an object (breath etc) and deselection of other stimuli
Adfærdsmæssigt: Focused Attention (FA)
Eksperimentel: Open-Monitoring (OM)
This 8-week program consists solely of open monitoring practices, or noticing and/or labeling the contents of ongoing experience ( thoughts, body sensations, emotions, seeing, hearing etc) without focusing on or deselecting any stimuli
Adfærdsmæssigt: Open- Monitoring
Eksperimentel: Mindfulness-Based Cognitive Therapy (MBCT)
The 8 week MBCT program follows the 2nd Edition (2012) manual (Segal, Williams, Teasdale) and includes both focused attention and open- monitoring practices
Adfærdsmæssigt: Mindfulness-Based Cognitive Therapy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Inventory of Depressive Symptomatology
Tidsramme: baseline, 8 weeks, 20 weeks
30-item clinician administered interview about unipolar depression symptoms
baseline, 8 weeks, 20 weeks
change in Depression, Anxiety Stress Scale (DASS)
Tidsramme: baseline, week 2,4,6,8, 20
42-item self-report questionnaire on depression, anxiety and stress symptoms
baseline, week 2,4,6,8, 20
change in Wellbeing Scale (WBS)
Tidsramme: baseline, 8 weeks, 20 weeks
73-item self-report questionnaire of psychological wellbeing
baseline, 8 weeks, 20 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in alpha-theta EEG power from baseline to 8 weeks
Tidsramme: baseline and 8 weeks
Resting/spontaneous EEG power in 5-9 Hz range
baseline and 8 weeks
Change in Facial EMG power from baseline to 8 weeks
Tidsramme: baseline and 8 weeks
Facial EMG response to emotional (IAPS) photos (reactivity + regulation)
baseline and 8 weeks
Sustained Attention to response Task (SART)
Tidsramme: baseline, 8 weeks
40 minuted sustained attention, go-no-go task
baseline, 8 weeks
Difficulties in Emotion Regulation Scale (DERS)
Tidsramme: baseline, 8 weeks, 20 weeks
36-item self report of emotion regulation
baseline, 8 weeks, 20 weeks
Attention Control Questionnaire (Derryberry & Reed, 2002)
Tidsramme: baseline, 8 weeks, 20 weeks
20-item self report measure of attentional abilities
baseline, 8 weeks, 20 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Five Facet Mindfulness Questionnaire (FFMQ)
Tidsramme: baseline, week 3,5,7,8,20
39-item self-report questionnaire of mindfulness skill acquisition (attention, non-reactivity)
baseline, week 3,5,7,8,20
Self-Compassion Scale (Neff 2003)
Tidsramme: baseline, 8 weeks, 20 weeks
26-item self report of attitudes towards oneself
baseline, 8 weeks, 20 weeks
Positive and Negative Affect Scale (PANAS)
Tidsramme: week 1,2,3,4,5,6,7,8
60-item self report of emotional states
week 1,2,3,4,5,6,7,8

Samarbejdspartnere og efterforskere

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

Sponsor

Brown University

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

Hjælpsomme links

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. februar 2013

Primær færdiggørelse (Faktiske)

15. marts 2016

Studieafslutning (Faktiske)

15. marts 2016

Datoer for studieregistrering

Først indsendt

10. april 2013

Først indsendt, der opfyldte QC-kriterier

11. april 2013

Først opslået (Skøn)

15. april 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. november 2018

Sidst verificeret

1. november 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • K23AT006328-01A1 (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 .

Kliniske forsøg med Mild-moderate Unipolar Depression; Persistent Negative Affect

Kliniske forsøg med Focused Attention (FA)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Greece

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner