Dismantling Mindfulness: Contributions of Attention vs. Acceptance

Mild-moderate Unipolar Depression; Persistent Negative Affect Clinical Trial

Official title:

Dismantling Mindfulness: Contributions of Attention vs. Acceptance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01831362
• Other study ID #: K23AT006328-01A1
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: March 15, 2016

Study information

• Verified date: November 2018
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: March 15, 2016
• Est. primary completion date: March 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Mild-moderate Unipolar Depression; Persistent Negative Affect

Intervention

Behavioral:
• Mindfulness-Based Cognitive Therapy

• Focused Attention (FA)

• Open- Monitoring

Locations

Country	Name	City	State
United States	Brown University Clinical and Affective Neuroscience Laboratory	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Five Facet Mindfulness Questionnaire (FFMQ)	39-item self-report questionnaire of mindfulness skill acquisition (attention, non-reactivity)	baseline, week 3,5,7,8,20
Other	Self-Compassion Scale (Neff 2003)	26-item self report of attitudes towards oneself	baseline, 8 weeks, 20 weeks
Other	Positive and Negative Affect Scale (PANAS)	60-item self report of emotional states	week 1,2,3,4,5,6,7,8
Primary	Change in Inventory of Depressive Symptomatology	30-item clinician administered interview about unipolar depression symptoms	baseline, 8 weeks, 20 weeks
Primary	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
Primary	change in Wellbeing Scale (WBS)	73-item self-report questionnaire of psychological wellbeing	baseline, 8 weeks, 20 weeks
Secondary	Change in alpha-theta EEG power from baseline to 8 weeks	Resting/spontaneous EEG power in 5-9 Hz range	baseline and 8 weeks
Secondary	Change in Facial EMG power from baseline to 8 weeks	Facial EMG response to emotional (IAPS) photos (reactivity + regulation)	baseline and 8 weeks
Secondary	Sustained Attention to response Task (SART)	40 minuted sustained attention, go-no-go task	baseline, 8 weeks
Secondary	Difficulties in Emotion Regulation Scale (DERS)	36-item self report of emotion regulation	baseline, 8 weeks, 20 weeks
Secondary	Attention Control Questionnaire (Derryberry & Reed, 2002)	20-item self report measure of attentional abilities	baseline, 8 weeks, 20 weeks

External Links

•   Brown University's Clinical and Affective Neuroscience Laboratory