Dismantling Mindfulness: Contributions of Attention vs. Acceptance

Brown University

Status: Completed

Conditions: Mild-moderate Unipolar Depression; Persistent Negative Affect

Treatments: Behavioral: Mindfulness-Based Cognitive Therapy; Behavioral: Open- Monitoring; Behavioral: Focused Attention (FA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01831362

K23AT006328-01A1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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104 participants in 3 patient groups

Focused Attention (FA)

Experimental group

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

Treatment:

Behavioral: Focused Attention (FA)

Open-Monitoring (OM)

Experimental group

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

Treatment:

Behavioral: Open- Monitoring

Mindfulness-Based Cognitive Therapy (MBCT)

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness-Based Cognitive Therapy