Dismantling Mindfulness: Contributions of Attention vs. Acceptance

Sponsor
Brown University (Other)
Overall Status
Completed
CT.gov ID
NCT01831362
Collaborator
(none)
104
1
3
37.4
2.8

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness-Based Cognitive Therapy
  • Behavioral: Focused Attention (FA)
  • Behavioral: Open- Monitoring
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Dismantling Mindfulness: Contributions of Attention vs. Acceptance
Study Start Date :
Feb 1, 2013
Actual Primary Completion Date :
Mar 15, 2016
Actual Study Completion Date :
Mar 15, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Inventory of Depressive Symptomatology [baseline, 8 weeks, 20 weeks]

    30-item clinician administered interview about unipolar depression symptoms

  2. change in Depression, Anxiety Stress Scale (DASS) [baseline, week 2,4,6,8, 20]

    42-item self-report questionnaire on depression, anxiety and stress symptoms

  3. change in Wellbeing Scale (WBS) [baseline, 8 weeks, 20 weeks]

    73-item self-report questionnaire of psychological wellbeing

Secondary Outcome Measures

  1. Change in alpha-theta EEG power from baseline to 8 weeks [baseline and 8 weeks]

    Resting/spontaneous EEG power in 5-9 Hz range

  2. Change in Facial EMG power from baseline to 8 weeks [baseline and 8 weeks]

    Facial EMG response to emotional (IAPS) photos (reactivity + regulation)

  3. Sustained Attention to response Task (SART) [baseline, 8 weeks]

    40 minuted sustained attention, go-no-go task

  4. Difficulties in Emotion Regulation Scale (DERS) [baseline, 8 weeks, 20 weeks]

    36-item self report of emotion regulation

  5. Attention Control Questionnaire (Derryberry & Reed, 2002) [baseline, 8 weeks, 20 weeks]

    20-item self report measure of attentional abilities

Other Outcome Measures

  1. Five Facet Mindfulness Questionnaire (FFMQ) [baseline, week 3,5,7,8,20]

    39-item self-report questionnaire of mindfulness skill acquisition (attention, non-reactivity)

  2. Self-Compassion Scale (Neff 2003) [baseline, 8 weeks, 20 weeks]

    26-item self report of attitudes towards oneself

  3. Positive and Negative Affect Scale (PANAS) [week 1,2,3,4,5,6,7,8]

    60-item self report of emotional states

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brown University Clinical and Affective Neuroscience Laboratory Providence Rhode Island United States 02912

Sponsors and Collaborators

  • Brown University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Willoughby Britton, Assistant Professor of Psychiatry and Human Behavior, Brown University
ClinicalTrials.gov Identifier:
NCT01831362
Other Study ID Numbers:
  • K23AT006328-01A1
First Posted:
Apr 15, 2013
Last Update Posted:
Nov 5, 2018
Last Verified:
Nov 1, 2018
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 5, 2018