Virginia Commonwealth University Stress Reduction Study

Study Overview
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Brief Summary
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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 and reactions to social conflict.

Detailed Description
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The full research project will be conducted over approximately 2-3 weeks, and will consist of two data collection sessions, one before and one after a 14-day stress reduction training course conducted via a smartphone that participants provide. This course entails instructor-facilitated stress reduction exercises previously shown to reduce stress and improve well-being. Participants will be randomly assigned to a mindfulness course or a cognitive reappraisal course. Both of these courses -mindfulness training (MT) and cognitive reappraisal training (RT) - involve expert-facilitated mental wellness techniques. MT emphasizes mindfulness-based techniques to reduce stress and promote wellbeing, whereas CT emphasizes reframing and reappraisal techniques to reduce stress and promote well-being.

Official Title
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Virginia Commonwealth University Stress Reduction Study

Conditions
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Stress

Intervention / Treatment
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* Behavioral: mindfulness training
* Behavioral: cognitive reappraisal training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Adults aged 18 - 55 years of age Right hand dominant (will not be advertised but screened) Personal SmartPhone (Android or iOS operating systems). Naive to meditation practice (will not be advertised but screened) At least a moderate level of perceived stress (scale score > 5 on the 4-item Perceived Stress Scale (PSS; reflects above-average perceived stress) Exclusion Criteria: left-handed are unwilling or unable to complete study assessments or treatments 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 � pack per day, alcohol intake in excess of 2 drinks per day) are prisoners no personal SmartPhone (Android or iOS operating systems)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 88 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 |
| --- | --- |
| Experimental: Mindfulness<br> | Behavioral: mindfulness training<br>* Participants will listen to 20-minute lessons each day for 14 days plus complete brief (3 to 10 minute) exercises daily via their personal smartphone. Each course will involve mental exercises to reduce stress in daily life, along with direct instruction from the course leader to help in learning and applying the stress reduction techniques.<br>|
| Active Comparator: Cognitive reappraisal<br> | Behavioral: cognitive reappraisal training<br>* Participants will listen to 20-minute lessons each day for 14 days plus complete brief (3 to 10 minute) exercises daily via their personal smartphone. Each course will involve mental exercises to reduce stress in daily life, along with direct instruction from the course leader to help in learning and applying the stress reduction techniques.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional near-infrared spectroscopy (fNIRS) hemodynamic signal change | Proportion of participants who show a statistically significant change in regional specificity, as measured by fNIRS-recorded blood oxygenation representing markers of emotion reactivity and regulation during observation of video stimuli. | Baseline and 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anger response | The Anger subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess s the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli. Lower scores indicate less anger and more emotion downregulation. Higher scores would indicate more anger and less emotion downregulation. | Baseline and 16 weeks | 
| Change in disgust response | The Disgust subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli. Lower scores indicate less disgust and more emotion downregulation. Higher scores would indicate more disgust and less emotion downregulation. | Baseline and 16 weeks | 
| Change in fear response | The Fear subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli. Lower scores indicate less fear and more emotion downregulation. Higher scores would indicate more fear and less emotion downregulation. | Baseline and 16 weeks | 
| Change in anxiety response | The Anxiety subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli. Lower scores indicate less anxiety and more emotion downregulation. Higher scores would indicate more anxiety and less emotion downregulation. | Baseline and 16 weeks | 
| Change in sadness response | The Sadness subscale of the Discrete Emotions Questionnaire (DEQ) will be used to assess the extent to which participants experience specific emotions on a scale from 1 (not at all) to 7 (an extreme amount) in response to video stimuli. Lower scores indicate less sadness and more emotion downregulation. Higher scores would indicate more sadness and less emotion downregulation. | Baseline and 16 weeks | 
| Change in intergroup attitudes | The Beliefs about Groups survey will be used to assess explicit intergroup attitudes. Participants answer 4 questions using a scale from 1 to 6. Higher scores indicate poorer attitude outcomes. | Baseline and 16 weeks | 
| Behavioral willingness to participate in a dyad-based future experiment | Number of participants who express willingness to participate in a dyad-based future experiment using a scale from 1 to 5. Higher scores indicate greater willingness or preference to participate. | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness