Dismantling Mindfulness: Contributions of Attention vs. Acceptance

NCT ID: NCT01831362

Last Updated: 2018-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-03-15

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Mild-moderate Unipolar Depression; Persistent Negative Affect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Focused Attention (FA)

Intervention Type BEHAVIORAL

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

Group Type EXPERIMENTAL

Open- Monitoring

Intervention Type BEHAVIORAL

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

Group Type EXPERIMENTAL

Mindfulness-Based Cognitive Therapy

Intervention Type BEHAVIORAL

Interventions

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Mindfulness-Based Cognitive Therapy

Intervention Type BEHAVIORAL

Focused Attention (FA)

Intervention Type BEHAVIORAL

Open- Monitoring

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brown University

OTHER

Sponsor Role lead

Responsible Party

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Willoughby Britton

Assistant Professor of Psychiatry and Human Behavior

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brown University Clinical and Affective Neuroscience Laboratory

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33434227 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33038188 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29106898 (View on PubMed)

Related Links

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https://www.brown.edu/research/labs/britton/

Brown University's Clinical and Affective Neuroscience Laboratory

Other Identifiers

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K23AT006328-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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