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Dismantling Mindfulness: Contributions of Attention vs. Acceptance

Primary Purpose

Mild-moderate Unipolar Depression; Persistent Negative Affect

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Cognitive Therapy
Focused Attention (FA)
Open- Monitoring
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild-moderate Unipolar Depression; Persistent Negative Affect

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brown University Clinical and Affective Neuroscience Laboratory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Focused Attention (FA)

Open-Monitoring (OM)

Mindfulness-Based Cognitive Therapy (MBCT)

Arm Description

This 8 week program consists solely of focused attention practices, i.e. selected attention to an object (breath etc) and deselection of other stimuli

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

The 8 week MBCT program follows the 2nd Edition (2012) manual (Segal, Williams, Teasdale) and includes both focused attention and open- monitoring practices

Outcomes

Primary Outcome Measures

Change in Inventory of Depressive Symptomatology
30-item clinician administered interview about unipolar depression symptoms
change in Depression, Anxiety Stress Scale (DASS)
42-item self-report questionnaire on depression, anxiety and stress symptoms
change in Wellbeing Scale (WBS)
73-item self-report questionnaire of psychological wellbeing

Secondary Outcome Measures

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

Full Information

First Posted
April 10, 2013
Last Updated
November 1, 2018
Sponsor
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT01831362
Brief Title
Dismantling Mindfulness: Contributions of Attention vs. Acceptance
Official Title
Dismantling Mindfulness: Contributions of Attention vs. Acceptance
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 15, 2016 (Actual)
Study Completion Date
March 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild-moderate Unipolar Depression; Persistent Negative Affect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Focused Attention (FA)
Arm Type
Experimental
Arm Description
This 8 week program consists solely of focused attention practices, i.e. selected attention to an object (breath etc) and deselection of other stimuli
Arm Title
Open-Monitoring (OM)
Arm Type
Experimental
Arm Description
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
Arm Title
Mindfulness-Based Cognitive Therapy (MBCT)
Arm Type
Experimental
Arm Description
The 8 week MBCT program follows the 2nd Edition (2012) manual (Segal, Williams, Teasdale) and includes both focused attention and open- monitoring practices
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Cognitive Therapy
Intervention Type
Behavioral
Intervention Name(s)
Focused Attention (FA)
Intervention Type
Behavioral
Intervention Name(s)
Open- Monitoring
Primary Outcome Measure Information:
Title
Change in Inventory of Depressive Symptomatology
Description
30-item clinician administered interview about unipolar depression symptoms
Time Frame
baseline, 8 weeks, 20 weeks
Title
change in Depression, Anxiety Stress Scale (DASS)
Description
42-item self-report questionnaire on depression, anxiety and stress symptoms
Time Frame
baseline, week 2,4,6,8, 20
Title
change in Wellbeing Scale (WBS)
Description
73-item self-report questionnaire of psychological wellbeing
Time Frame
baseline, 8 weeks, 20 weeks
Secondary Outcome Measure Information:
Title
Change in alpha-theta EEG power from baseline to 8 weeks
Description
Resting/spontaneous EEG power in 5-9 Hz range
Time Frame
baseline and 8 weeks
Title
Change in Facial EMG power from baseline to 8 weeks
Description
Facial EMG response to emotional (IAPS) photos (reactivity + regulation)
Time Frame
baseline and 8 weeks
Title
Sustained Attention to response Task (SART)
Description
40 minuted sustained attention, go-no-go task
Time Frame
baseline, 8 weeks
Title
Difficulties in Emotion Regulation Scale (DERS)
Description
36-item self report of emotion regulation
Time Frame
baseline, 8 weeks, 20 weeks
Title
Attention Control Questionnaire (Derryberry & Reed, 2002)
Description
20-item self report measure of attentional abilities
Time Frame
baseline, 8 weeks, 20 weeks
Other Pre-specified Outcome Measures:
Title
Five Facet Mindfulness Questionnaire (FFMQ)
Description
39-item self-report questionnaire of mindfulness skill acquisition (attention, non-reactivity)
Time Frame
baseline, week 3,5,7,8,20
Title
Self-Compassion Scale (Neff 2003)
Description
26-item self report of attitudes towards oneself
Time Frame
baseline, 8 weeks, 20 weeks
Title
Positive and Negative Affect Scale (PANAS)
Description
60-item self report of emotional states
Time Frame
week 1,2,3,4,5,6,7,8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Brown University Clinical and Affective Neuroscience Laboratory
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33434227
Citation
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.
Results Reference
derived
PubMed Identifier
33038188
Citation
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.
Results Reference
derived
PubMed Identifier
29106898
Citation
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.
Results Reference
derived
Links:
URL
https://www.brown.edu/research/labs/britton/
Description
Brown University's Clinical and Affective Neuroscience Laboratory

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Dismantling Mindfulness: Contributions of Attention vs. Acceptance

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