- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01831362
Dismantling Mindfulness: Contributions of Attention vs. Acceptance
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).
Aperçu de l'étude
Statut
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Rhode Island
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Providence, Rhode Island, États-Unis, 02912
- Brown University Clinical and Affective Neuroscience Laboratory
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Expérimental: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Inventory of Depressive Symptomatology
Délai: 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)
Délai: 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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in alpha-theta EEG power from baseline to 8 weeks
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Five Facet Mindfulness Questionnaire (FFMQ)
Délai: 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)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- K23AT006328-01A1 (Subvention/contrat des NIH des États-Unis)
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