Comparison of Two Behavioral Treatments for Stress Reduction

Study Overview
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Brief Summary
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Currently there are 2 popular stress reduction courses that are widely used in the US. Although they use somewhat similar techniques, it is currently unknown whether or not they work the same way, or if they are similarly effective at reducing stress. The study will directly compare these 2 courses. Participants will undergo approximately 4-5 hours of testing before and after each 8-week course.

Official Title
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Exploratory Analysis of the Relaxation Response (RR) and Mindfulness Based Stress Reduction (MBSR) for Stress Reduction

Conditions
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Stress

Intervention / Treatment
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* Behavioral: RR
* Behavioral: MBSR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 25 to 60 years old Good general health Able to attend all 8 sessions of the course and practice the techniques each night for 25 minutes Exclusion Criteria: Psychiatric medications Significant medical or psychological illness Metalic implants (such as a pacemaker or artificial joints) that are not MRI compatible. Claustrophobia Pregnancy Previous head trauma or neurological disorder Previous experience with yoga or meditation

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Program A - Relaxation Response (RR)<br>One of the 2 stress reduction courses | Behavioral: RR<br>* A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing relaxation<br>|
| Active Comparator: Program B - Mindfullness-based stress reduction (MBSR)<br>One of the 2 stress reduction courses | Behavioral: MBSR<br>* A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing mindfulness<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain Activity (fMRI) During the Body Scan Meditation | Seed based functional connectivity analysis was performed using the Connectivity Toolbox (CONN) implemented within the Statistical Parametric Mapping program (SPM8; Welcome Department of Cognitive Neurology). Our seeds were located in the right inferior frontal gyrus pars opercularis (MNI coordinates: 54, 14, 16) and the dorsal anterior insula (MNI coordinates: 32, 20, 0). Note - MRI data from some subjects was either missing, not collected, or corrupted, and so the analyses were performed on just the subject of subjects who had complete datasets. This assessment reflects the total number of voxels per group. | Week 8 | 
| Five Facet Mindfulness Questionnaire | The Five Facet Mindfulness Questionnaire (FFMQ) has been developed as a reliable and valid comprehensive instrument for assessing different aspects of mindfulness in community samples. Scores range from 39-195 with higher scores meaning more mindfulness. | Pre, 8 weeks | 
| Perceived Stress Scale | The PSS is brief, validated and widely used psychological instrument for assessing a subject's perception of stress change. Scores range from 0-40 with higher scores meaning more stress | Pre, 8 weeks | 
| Penn State Worry Questionnaire | The Penn State Worry Questionnaire (PSWQ) is a standard self-report questionnaire that is designed to assess symptoms of General Anxiety Disorder. scores range from 16-80 with higher scores meaning more stress. | Pre, 8 weeks | 
| Anxiety Severity Index | the Anxiety Sensitivity Index (ASI) is a measure of individuals discomfort with a variety of sensations associated with anxiety and panic and tends to be substantially higher in those with panic disorder (and attacks) than in those with General Anxiety Disorder. Scores range from 0 - 64. Lower scores mean lower anxiety. | Pre, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self Compassion | This scale assesses one's ability to be forgiving and kind to oneself in difficult circumstances. Scores range from 1-5. Higher scores mean more self compassion. | Pre, week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress, meditation, stress reduction, fMRI, behavioral