Mechanisms of Mindfulness and Stress Resilience: A Mobile App Mindfulness Training Study

Study Overview
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Brief Summary
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The purpose of this study is to test the active components of mindfulness meditation for reducing psychological stress and improving biomarkers of health. This study compares the effects of three brief trainings: (1) training in both present-moment attention and mindful acceptance, (2) training in present-focused attention, and (3) an active psychological training with no mindfulness content.

Detailed Description
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Mindfulness meditation practices are widely used among the general public, with people seeking to reduce stress, pain, inflammation, depression, and disease symptoms. Moreover, randomized controlled trials have shown mindfulness training programs to be effective in improving a broad range of psychological and physical health outcomes, particularly among populations with high stress burdens. Still, little is known about the mechanisms underlying mindfulness training that drive these effects. This study tests the active components of mindfulness that impact stress responding and health biomarkers. The study separates attention and acceptance mindfulness instructions into three 14-day training programs delivered to a stressed adult population: (1) attention and acceptance instructions, (2) attentional monitoring instructions only, or (3) analytic thinking with no mindfulness instruction. Intervention programs are delivered on participants' own smartphones, providing a platform for maximal experimental control in testing the active ingredients of mindfulness training. Participants are recruited from the Pittsburgh community. At a baseline laboratory session, they complete psychosocial questionnaires and tasks and provide a dried blood spot sample. On their own, they complete pre- and post-intervention Ecological Momentary Assessment measures of stress, attention, and acceptance in daily life. Between these assessments, participants have 14 days to complete their randomly assigned 14-lesson intervention program. Participants return to the lab for post-intervention assessments (questionnaires, tasks, dried blood sample), listen to a final training session from their intervention program, and complete the Trier Social Stress Test. Participants are compensated.

Conditions
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Psychological Stress, Mindfulness

Intervention / Treatment
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* Behavioral: Mindfulness Training
* Behavioral: Mindful Attention Only Training
* Behavioral: Analytic Thinking Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking Moderate- to high-stress (4-item Perceived Stress Scale score of 6 or higher) Exclusion Criteria: Diagnosis of chronic mental (e.g., recurrent depression, schizophrenia, personality disorder) or physical disease (e.g., cancer, HIV, heart disease, diabetes, bleeding disorder) Hospitalization in past 3 months Medication use that interferes with HPA-axis activity (e.g., corticosteroids) Current oral contraceptive use Current antibiotic, antiviral, or antimicrobial treatment Travel outside the country within the past 6 months to any country on the CDC 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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No

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>14-lesson audio-guided mindfulness training program instructing present-moment attention and an orientation of acceptance | Behavioral: Mindfulness Training<br>* Mindfulness training intervention consisting of 14 x 20-minute audio-guided lessons that participants access on their smartphones during the 14-day intervention period.<br>|
| Active Comparator: Mindful Attention Only Training<br>14-lesson audio-guided mindfulness training program instructing present-moment attention only | Behavioral: Mindful Attention Only Training<br>* Mindful attention training intervention consisting of 14 x 20-minute audio-guided lessons that participants access on their smartphones during the 14-day intervention period.<br>|
| Active Comparator: Analytic Thinking Training<br>14-lesson audio-guided analytic thinking program encouraging reflection on one's thoughts, feelings, and behaviors, but not instructing mindfulness | Behavioral: Analytic Thinking Training<br>* Comparison analytic thinking intervention consisting of 14 x 20-minute audio-guided lessons that participants access on their smartphones during the 14-day intervention period.<br>|

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 2.5 weeks | 
| Inflammatory Biomarkers assessed via Dried Blood Spot | Five Dried Blood Spot samples are obtained from participants' finger for assessment of circulating markers of inflammation (CRP, IL-6). | change from baseline to post-intervention, which is an average of 3.5 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 2.5 weeks | 
| Subjective stress in response to social evaluative threat (TSST) |  | assessed at post-intervention, which is an average of 3.5 weeks | 
| Salivary Cortisol AUC in response to social evaluative threat (TSST) |  | assessed at post-intervention, which is an average of 3.5 weeks, at time 0, and 25, 35, and 60 minutes post-TSST | 
| Blood Pressure reactivity to social evaluative threat (TSST) |  | assessed at post-intervention, which is an average of 3.5 weeks, at 2-minute intervals during session | 
| Evening salivary cortisol |  | change from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks | 
| Sustained attention measured by the Dichotic Listening Task |  | change from baseline to post-intervention, which is an average of 3.5 weeks | 

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