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).

Study Overview

• Status: Completed
• Conditions: Mild-moderate Unipolar Depression; Persistent Negative Affect
• Intervention / Treatment: Behavioral: Focused Attention (FA); Behavioral: Open- Monitoring; Behavioral: Mindfulness-Based Cognitive Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Brown University Clinical and Affective Neuroscience Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Focused Attention (FA)
Experimental: 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	Behavioral: Open- Monitoring
Experimental: 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	Behavioral: Mindfulness-Based Cognitive Therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in alpha-theta EEG power from baseline to 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	Facial EMG response to emotional (IAPS) photos (reactivity + regulation)	baseline and 8 weeks
Sustained Attention to response Task (SART)	40 minuted sustained attention, go-no-go task	baseline, 8 weeks
Difficulties in Emotion Regulation Scale (DERS)	36-item self report of emotion regulation	baseline, 8 weeks, 20 weeks
Attention Control Questionnaire (Derryberry & Reed, 2002)	20-item self report measure of attentional abilities	baseline, 8 weeks, 20 weeks

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brown University

Publications and helpful links

General Publications

• 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.

Helpful Links

• Brown University's Clinical and Affective Neuroscience Laboratory

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): March 15, 2016
• Study Completion (Actual): March 15, 2016

Study Registration Dates

• First Submitted: April 10, 2013
• First Submitted That Met QC Criteria: April 11, 2013
• First Posted (Estimate): April 15, 2013

Study Record Updates

• Last Update Posted (Actual): November 5, 2018
• Last Update Submitted That Met QC Criteria: November 1, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder
• Other Study ID Numbers: K23AT006328-01A1 (U.S. NIH Grant/Contract)