Clinical trial NCT01831362: Dismantling Mindfulness: Contributions of Attention vs. Acceptance
Official title: Dismantling Mindfulness: Contributions of Attention vs. Acceptance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild-moderate Unipolar Depression; Persistent Negative Affect
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2013-04-15
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Inventory of Depressive Symptomatology
timeFrame: baseline, 8 weeks, 20 weeks
measure: change in Depression, Anxiety Stress Scale (DASS)
timeFrame: baseline, week 2,4,6,8, 20
measure: change in Wellbeing Scale (WBS)
timeFrame: baseline, 8 weeks, 20 weeks
Secondary outcomes:
measure: Change in alpha-theta EEG power from baseline to 8 weeks
timeFrame: baseline and 8 weeks
measure: Change in Facial EMG power from baseline to 8 weeks
timeFrame: baseline and 8 weeks
measure: Sustained Attention to response Task (SART)
timeFrame: baseline, 8 weeks
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: baseline, 8 weeks, 20 weeks
measure: Attention Control Questionnaire (Derryberry & Reed, 2002)
timeFrame: baseline, 8 weeks, 20 weeks
Other outcomes:
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: baseline, week 3,5,7,8,20
measure: Self-Compassion Scale (Neff 2003)
timeFrame: baseline, 8 weeks, 20 weeks
measure: Positive and Negative Affect Scale (PANAS)
timeFrame: week 1,2,3,4,5,6,7,8
Locations:
city: Providence
country: United States
facility: Brown University Clinical and Affective Neuroscience Laboratory
state: Rhode Island
Study officials:
References:
citation: Cullen B, Eichel K, Lindahl JR, Rahrig H, Kini N, Flahive J, Britton WB. The contributions of focused attention and open monitoring in mindfulness-based cognitive therapy for affective disturbances: A 3-armed randomized dismantling trial. PLoS One. 2021 Jan 12;16(1):e0244838. doi: 10.1371/journal.pone.0244838. eCollection 2021.
citation: Canby NK, Eichel K, Peters SI, Rahrig H, Britton WB. Predictors of Out-of-Class Mindfulness Practice Adherence During and After a Mindfulness-Based Intervention. Psychosom Med. 2021 Jul-Aug 01;83(6):655-664. doi: 10.1097/PSY.0000000000000873.
citation: Britton WB, Davis JH, Loucks EB, Peterson B, Cullen BH, Reuter L, Rando A, Rahrig H, Lipsky J, Lindahl JR. Dismantling Mindfulness-Based Cognitive Therapy: Creation and validation of 8-week focused attention and open monitoring interventions within a 3-armed randomized controlled trial. Behav Res Ther. 2018 Feb;101:92-107. doi: 10.1016/j.brat.2017.09.010. Epub 2017 Sep 28.