Mechanisms of Mindfulness Training and Stress Reduction

Study Overview
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Brief Summary
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This study is a three-arm randomized controlled trial of a mindfulness stress reduction intervention, with the aim of dismantling the experience-monitoring and nonjudgmental-acceptance elements of mindfulness programs to determine the active treatment component. In addition to enhancing understanding of mechanisms underlying the effects of mindfulness interventions, identifying the therapeutic constituent(s) could inform development of targeted interventions as well as provide strategies to optimize adherence.

Detailed Description
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There is a growing body of randomized controlled trial (RCT) evidence indicating that mindfulness training interventions may reduce stress and improve stress-related disease outcomes. Yet little is known about the underlying active training mechanisms of mindfulness training. Although it is generally believed that mindfulness training interventions foster a capacity to monitor and accept present moment experience, debate currently focuses on whether it is the capacity to both monitor and non-judgmentally accept experience that drives the salutary effects observed in mindfulness training interventions. This project will test these putative active mechanisms by comparing two different types of mindfulness meditation training programs. N=135 stressed community adults will be recruited and randomized to either two different types of 8-week Mindfulness-Based Stress Reduction (MBSR) programs or a No Treatment Control (assessment only) comparison condition. Participants will complete 3 days of daily experience sampling (Ecological Momentary Assessment) immediately before and after the 8-week intervention period to measure attentional control and stress perceptions in daily life. In order to measure psychological and HPA-axis stress reactivity to a controlled stressor, participants will also complete a standardized acute stress challenge task (the Trier Social Stress Test, TSST) immediately following the 3-day post-intervention assessment period. This project provides the first dismantling study of mindfulness meditation training, it utilizes cutting-edge daily experience sampling of real life stress (using EMA) and stress biomarkers (salivary cortisol), and will provide important initial information for designing more effective (and efficient) mindfulness training interventions in at-risk stressed patient populations.

Official Title
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Mechanisms of Mindfulness Training and Stress Reduction

Conditions
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Mindfulness, Psychological Stress

Intervention / Treatment
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* Behavioral: Mindfulness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking Moderate- to high-stress Owns an internet-enabled smart phone Exclusion Criteria: Diagnosis of chronic mental (e.g. recurrent depression, schizophrenia, personality disorder) or physical disease (e.g. cancer, HIV, diabetes) Hospitalization in past 3 months Medication use that interferes with cortisol activity (e.g. corticosteroids) Current oral contraceptive use Pregnancy Current antibiotic, antiviral, or antimicrobial treatment Travel outside the country within the past 6 months to any country on the Center for Disease Control travel alert list Recreational drug use, excessive alcohol or tobacco use Significant experience with or daily practice of mindfulness meditation or related mind-body practice

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mindfulness Training<br>Mindfulness training intervention consisting of eight weekly 2.5 hour group sessions, a day-long retreat in the sixth week, and daily home mindfulness meditation | Behavioral: Mindfulness<br>* Mindfulness training practices aim to foster attention and acceptance toward one's present moment experience. Mindfulness consists of two components-- (1) deploying attention to monitor one's moment-to-moment experience, and (2) fostering an attitude of acceptance toward one's moment-to-moment experience<br>|
| Active Comparator: Mindful Attention Only Training<br>Mindful attention only training intervention consisting of eight weekly 2.5 hour group sessions, a day-long retreat in the sixth week, and daily home mindfulness meditation | Behavioral: Mindfulness<br>* Mindfulness training practices aim to foster attention and acceptance toward one's present moment experience. Mindfulness consists of two components-- (1) deploying attention to monitor one's moment-to-moment experience, and (2) fostering an attitude of acceptance toward one's moment-to-moment experience<br>|
| No Intervention: No Treatment Control Condition<br>No treatment participants will be informed that their participation is important and that they are requested to not seek out similar treatments during this waiting period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily life stress assessed via Ecological Momentary Assessment |  | change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily life state attention and acceptance assessed via Ecological Momentary Assessment |  | change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks | 
| Subjective stress in response to social evaluative threat |  | assessed at post-intervention, which is an average of 14 weeks | 
| Salivary Cortisol in response to social evaluative threat |  | assessed at post-intervention, which is an average of 14, at time 0, and 25, 35, and 60 minutes post-stress challenge | 
| Blood Pressure reactivity to social evaluative threat (systolic and diastolic blood pressure) |  | assessed at post-intervention, which is an average of 14 weeks, at 2-minute intervals during session | 
| Sustained attention measured by the Dichotic Listening Task |  | change from baseline to post-intervention, which is an average of 14 weeks | 
| Sustained inattentional blindness measured by the Inattentional Blindness Task |  | post-intervention only | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindfulness, psychological stress, wellness programs, cortisol