Dismantling Mindfulness: Contributions of Attention vs. Acceptance

Not Applicable

Completed

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

• Registration Number: NCT01831362
• Lead Sponsor: Brown University

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-15
• Primary Completion: 2016-03-15
• Study Completion: 2016-03-15
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-01
• Last Update Posted: 2018-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Mindfulness-Based Cognitive Therapy (MBCT)	Mindfulness-Based Cognitive Therapy	The 8 week MBCT program follows the 2nd Edition (2012) manual (Segal, Williams, Teasdale) and includes both focused attention and open- monitoring practices
Focused Attention (FA)	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
Open-Monitoring (OM)	Open- Monitoring	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

Primary Outcome Measures

Name	Time	Method
Change in Inventory of Depressive Symptomatology	baseline, 8 weeks, 20 weeks	30-item clinician administered interview about unipolar depression symptoms
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
change in Wellbeing Scale (WBS)	baseline, 8 weeks, 20 weeks	73-item self-report questionnaire of psychological wellbeing

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Brown University Clinical and Affective Neuroscience Laboratory; 🇺🇸 Providence, Rhode Island, United States