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| ID | Type | Description | Link |
|---|---|---|---|
| R21AT003425-01A2 | U.S. NIH Grant/Contract | View source | |
| SL1 |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Program A - Relaxation Response (RR) | Active Comparator | One of the 2 stress reduction courses |
|
| Program B - Mindfullness-based stress reduction (MBSR) | Active Comparator | One of the 2 stress reduction courses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RR | Behavioral | 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 |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Lazar, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02119 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Relaxation Response (RR) | One of the 2 stress reduction courses 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 |
| FG001 | Mindfulness Based Stress Reduction (MBSR) | One of the 2 stress reduction courses 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Relaxation Response | One of the 2 stress reduction courses Relaxation Response: A well-validated 8 week stress reduction course. Participants will be asked to perform stress reduction techniques from the Relaxation Response Program each night for 20 minutes throughout the entire 8-week course |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | voxels | Week 8 |
|
2 months
Participants were given a daily log in which to record their daily meditation practice, overall stress levels, and any information about their practice or unusual occurances that they wished to share with the study team. Any individual who missed a class or dropped out of the study were contacted to determine the reason.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Relaxation Response | One of the 2 stress reduction courses Program A: A well-validated 8 week stress reduction course. Classes meet once a week from 5-8:30 PM. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara Lazar | Massachusetts General Hospital | 617-724-2256 | slazar@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D001519 | Behavior |
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|
| MBSR | Behavioral | 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 |
|
| Pre, 8 weeks |
| MBSR |
One of the 2 stress reduction courses MBSR: A well-validated 8 week stress reduction course. Classes meet once a week from 5-8:30 PM. Participants will be asked to perform stress reduction techniques from the MBSR program each night for 20 minutes throughout the entire 8-week course |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Mindfulness Based Stress Reduction (MBSR) | One of the 2 stress reduction courses 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 |
|
|
| Primary | 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. | Individuals who completed at least one measure at post | Posted | Mean | Standard Deviation | units on a scale | Pre, 8 weeks |
|
|
|
|
| Primary | 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 | Individuals who completed at least one measure at post | Posted | Mean | Standard Deviation | units on a scale | Pre, 8 weeks |
|
|
|
|
| Primary | 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. | Individuals who completed at least one measure at post | Posted | Mean | Standard Deviation | units on a scale | Pre, 8 weeks |
|
|
|
|
| Primary | 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. | Individuals who completed at least one measure at post | Posted | Mean | Standard Deviation | units on a scale | Pre, 8 weeks |
|
|
|
|
| Secondary | 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. | individuals who completed the measure at week 8 | Posted | Mean | Standard Deviation | units on a scale | Pre, week 8 |
|
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | MBSR | One of the 2 stress reduction courses Program B: A well-validated 8 week stress reduction course. Classes meet once a week from 5-8:30 PM. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course | 0 | 28 | 0 | 28 | 0 | 28 |
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| Other |
within group change from pre to week 8 |
| .53 |
| Other |
| <.001 |
| Other |