Dismantling Mindfulness: Contributions of Attention vs. Acceptance
1. november 2018 oppdatert av: 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).
Studieoversikt
Status
Fullført
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
104
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Rhode Island
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Providence, Rhode Island, Forente stater, 02912
- Brown University Clinical and Affective Neuroscience Laboratory
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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
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Eksperimentell: 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
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Eksperimentell: 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
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Inventory of Depressive Symptomatology
Tidsramme: baseline, 8 weeks, 20 weeks
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30-item clinician administered interview about unipolar depression symptoms
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baseline, 8 weeks, 20 weeks
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change in Depression, Anxiety Stress Scale (DASS)
Tidsramme: baseline, week 2,4,6,8, 20
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42-item self-report questionnaire on depression, anxiety and stress symptoms
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baseline, week 2,4,6,8, 20
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change in Wellbeing Scale (WBS)
Tidsramme: baseline, 8 weeks, 20 weeks
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73-item self-report questionnaire of psychological wellbeing
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baseline, 8 weeks, 20 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in alpha-theta EEG power from baseline to 8 weeks
Tidsramme: baseline and 8 weeks
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Resting/spontaneous EEG power in 5-9 Hz range
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baseline and 8 weeks
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Change in Facial EMG power from baseline to 8 weeks
Tidsramme: baseline and 8 weeks
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Facial EMG response to emotional (IAPS) photos (reactivity + regulation)
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baseline and 8 weeks
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Sustained Attention to response Task (SART)
Tidsramme: baseline, 8 weeks
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40 minuted sustained attention, go-no-go task
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baseline, 8 weeks
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Difficulties in Emotion Regulation Scale (DERS)
Tidsramme: baseline, 8 weeks, 20 weeks
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36-item self report of emotion regulation
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baseline, 8 weeks, 20 weeks
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Attention Control Questionnaire (Derryberry & Reed, 2002)
Tidsramme: baseline, 8 weeks, 20 weeks
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20-item self report measure of attentional abilities
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baseline, 8 weeks, 20 weeks
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Five Facet Mindfulness Questionnaire (FFMQ)
Tidsramme: baseline, week 3,5,7,8,20
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39-item self-report questionnaire of mindfulness skill acquisition (attention, non-reactivity)
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baseline, week 3,5,7,8,20
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Self-Compassion Scale (Neff 2003)
Tidsramme: baseline, 8 weeks, 20 weeks
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26-item self report of attitudes towards oneself
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baseline, 8 weeks, 20 weeks
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Positive and Negative Affect Scale (PANAS)
Tidsramme: week 1,2,3,4,5,6,7,8
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60-item self report of emotional states
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week 1,2,3,4,5,6,7,8
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Cullen B, Eichel K, Lindahl JR, Rahrig H, Kini N, Flahive J, Britton WB. The contributions of focused attention and open monitoring in mindfulness-based cognitive therapy for affective disturbances: A 3-armed randomized dismantling trial. PLoS One. 2021 Jan 12;16(1):e0244838. doi: 10.1371/journal.pone.0244838. eCollection 2021.
- Canby NK, Eichel K, Peters SI, Rahrig H, Britton WB. Predictors of Out-of-Class Mindfulness Practice Adherence During and After a Mindfulness-Based Intervention. Psychosom Med. 2021 Jul-Aug 01;83(6):655-664. doi: 10.1097/PSY.0000000000000873.
- Britton WB, Davis JH, Loucks EB, Peterson B, Cullen BH, Reuter L, Rando A, Rahrig H, Lipsky J, Lindahl JR. Dismantling Mindfulness-Based Cognitive Therapy: Creation and validation of 8-week focused attention and open monitoring interventions within a 3-armed randomized controlled trial. Behav Res Ther. 2018 Feb;101:92-107. doi: 10.1016/j.brat.2017.09.010. Epub 2017 Sep 28.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2013
Primær fullføring (Faktiske)
15. mars 2016
Studiet fullført (Faktiske)
15. mars 2016
Datoer for studieregistrering
Først innsendt
10. april 2013
Først innsendt som oppfylte QC-kriteriene
11. april 2013
Først lagt ut (Anslag)
15. april 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. november 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. november 2018
Sist bekreftet
1. november 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- K23AT006328-01A1 (U.S. NIH-stipend/kontrakt)
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