Dismantling Mindfulness: Contributions of Attention vs. Acceptance

Study Overview
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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.

Official Title
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Dismantling Mindfulness: Contributions of Attention vs. Acceptance

Conditions
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Mild-moderate Unipolar Depression; Persistent Negative Affect

Intervention / Treatment
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* Behavioral: Mindfulness-Based Cognitive Therapy
* Behavioral: Focused Attention (FA)
* Behavioral: Open- Monitoring


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Focused Attention (FA)<br>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)<br> <br> |
| Experimental: Open-Monitoring (OM)<br>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<br> <br> |
| Experimental: Mindfulness-Based Cognitive Therapy (MBCT)<br>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<br> <br> |

What is the study measuring?
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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 |