Stress Reduction Training for Emotion Regulation and Well-Being

Study Overview
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Brief Summary
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This study will examine whether stress reduction training - which a growing body of research indicates has manifold benefits for behavior regulation, emotion regulation, and other salutary outcomes of relevance to this proposal - predicts lab-based and daily life-based neural and behavioral outcomes indicative of reduced stress, including emotions, desires, and reactions to adverse events such as social conflict.

Detailed Description
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This research study seeks to understand how stress reduction training influences neural responses (brain activation) and behavior related to stress, including emotions, desires, and reactions to adverse events such as social conflict. The full research project will be conducted over approximately 4-6 weeks, and will consist of two data collection sessions on the Virginia Commonwealth University (VCU) campus, one before and one after a 14-day stress reduction training course conducted via mobile phone (SmartPhone). The two courses entail instructor-facilitated stress reduction exercises previously shown to reduce stress and improve well-being. Participants will be randomly assigned to a mindfulness course or an active coping course. Both of these courses - mindfulness training (MT) and coping training (CT) - involve expert-facilitated mental wellness techniques. MT emphasizes mindfulness-based techniques to reduce stress and promote well-being, whereas CT emphasizes established emotion regulation techniques to reduce stress and promote well-being. Some study details are purposely omitted at this time to preserve scientific integrity.

Official Title
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The Virginia Commonwealth University (VCU) Stress Reduction Study

Conditions
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Stress Reduction

Intervention / Treatment
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* Behavioral: Mindfulness Training (MT)
* Behavioral: Active Coping Training (CT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking (will not be advertised but screened) Stable medication regiment for 8 weeks prior to enrollment if taking antidepressant or anxiolytic medications. (will not be advertised but screened) Free of major, uncorrected sensory impairments and cognitive deficits Free of a certain psychiatric disorders or history thereof; specifically, a new diagnosis of a (non-acute) medical or psychiatric condition within the last 3 months, report a hospitalization over the last 3 months, report current drug abuse (e.g., recreational drug use, alcohol intake in excess of 2 drinks per day). Personal SmartPhone (Android or Apple operating systems). Exclusion Criteria: non-English speaking are unwilling or unable to complete study assessments or treatments present fMRI safety risks (e.g., ferromagnetic implants, body weight > 300 lbs) report a new diagnosis of a (non-acute) medical or psychiatric condition within the last 3 months report a hospitalization over the last 3 months report current drug abuse (e.g., recreational drug use, smoke more than ½ pack per day, alcohol intake in excess of 2 drinks per day) are prisoners or pregnant women no personal SmartPhone (Android or Apple operating systems)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Training (MT)<br> | Behavioral: Mindfulness Training (MT)<br>* 2 week SmartPhone-based mindfulness training<br>|
| Experimental: Active Coping Training (CT)<br> | Behavioral: Active Coping Training (CT)<br>* 2 week SmartPhone-based structurally equivalent coping training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of lab-based emotion regulation (behavior) | Measured by affective face matching task | Baseline, post-test (within 3 weeks after intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neural activation associated with emotion regulation | Measured by functional magnetic resonance imaging (fMRI) during affective face matching task | Baseline, post-test (within 3 weeks after intervention) | 
| Change in level of stress, desires, social conflict in daily life | Measured by ecological momentary assessments of stress, desires, social interactions | Baseline, post-test (within 3 weeks after intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress, mindfulness, active coping