Stress
Conditions
Keywords
Stress, meditation, stress reduction, fMRI, behavioral
Brief summary
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.
Interventions
BEHAVIORALRR
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
BEHAVIORALMBSR
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
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain Activity (fMRI) During the Body Scan Meditation | Week 8 | 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. |
| Five Facet Mindfulness Questionnaire | Pre, 8 weeks | 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. |
| Perceived Stress Scale | Pre, 8 weeks | 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 |
| Penn State Worry Questionnaire | Pre, 8 weeks | 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. |
| Anxiety Severity Index | Pre, 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self Compassion | Pre, week 8 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 22 |
| 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 | 28 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | schedule conflict | 2 | 8 |
Baseline characteristics
| Characteristic | Relaxation Response | MBSR | Total |
|---|---|---|---|
| Age, Continuous | 39 years STANDARD_DEVIATION 8.7 | 37 years STANDARD_DEVIATION 4.7 | 37.9 years STANDARD_DEVIATION 6.5 |
| Sex: Female, Male Female | 15 Participants | 18 Participants | 33 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 28 |
| other Total, other adverse events | 0 / 22 | 0 / 28 |
| serious Total, serious adverse events | 0 / 22 | 0 / 28 |
Outcome results
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.
Time frame: Pre, 8 weeks
Population: Individuals who completed at least one measure at post
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relaxation Response (RR) | Anxiety Severity Index | Pre | 29.8 units on a scale | Standard Deviation 7.3 |
| Relaxation Response (RR) | Anxiety Severity Index | week 8 | 25.4 units on a scale | Standard Deviation 5.7 |
| Mindfulness Based Stress Reduction (MBSR) | Anxiety Severity Index | Pre | 31.9 units on a scale | Standard Deviation 9.4 |
| Mindfulness Based Stress Reduction (MBSR) | Anxiety Severity Index | week 8 | 30.9 units on a scale | Standard Deviation 8.6 |
Comparison: within group change from pre to week 8p-value: 0.015t-test, 2 sided
Comparison: within group change from pre to week 8p-value: 0.53t-test, 2 sided
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.
Time frame: Week 8
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relaxation Response (RR) | Brain Activity (fMRI) During the Body Scan Meditation | 74 voxels |
| Mindfulness Based Stress Reduction (MBSR) | Brain Activity (fMRI) During the Body Scan Meditation | 82 voxels |
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.
Time frame: Pre, 8 weeks
Population: Individuals who completed at least one measure at post
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relaxation Response (RR) | Five Facet Mindfulness Questionnaire | Pre | 130.8 units on a scale | Standard Deviation 17.7 |
| Relaxation Response (RR) | Five Facet Mindfulness Questionnaire | week 8 | 144.2 units on a scale | Standard Deviation 20.6 |
| Mindfulness Based Stress Reduction (MBSR) | Five Facet Mindfulness Questionnaire | Pre | 125.3 units on a scale | Standard Deviation 17.7 |
| Mindfulness Based Stress Reduction (MBSR) | Five Facet Mindfulness Questionnaire | week 8 | 139.1 units on a scale | Standard Deviation 21.1 |
Comparison: ANOVA for group by time interactionp-value: >0.1ANOVA
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.
Time frame: Pre, 8 weeks
Population: Individuals who completed at least one measure at post
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relaxation Response (RR) | Penn State Worry Questionnaire | Pre | 42.6 units on a scale | Standard Deviation 11.9 |
| Relaxation Response (RR) | Penn State Worry Questionnaire | week 8 | 37.7 units on a scale | Standard Deviation 10.1 |
| Mindfulness Based Stress Reduction (MBSR) | Penn State Worry Questionnaire | Pre | 50.5 units on a scale | Standard Deviation 13.1 |
| Mindfulness Based Stress Reduction (MBSR) | Penn State Worry Questionnaire | week 8 | 44.3 units on a scale | Standard Deviation 12 |
Comparison: within group change pre to week 8p-value: 0.022t-test, 2 sided
p-value: <0.001t-test, 2 sided
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
Time frame: Pre, 8 weeks
Population: Individuals who completed at least one measure at post
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relaxation Response (RR) | Perceived Stress Scale | Pre | 14.1 units on a scale | Standard Deviation 6.6 |
| Relaxation Response (RR) | Perceived Stress Scale | week 8 | 11.3 units on a scale | Standard Deviation 5.5 |
| Mindfulness Based Stress Reduction (MBSR) | Perceived Stress Scale | Pre | 18.4 units on a scale | Standard Deviation 6.7 |
| Mindfulness Based Stress Reduction (MBSR) | Perceived Stress Scale | week 8 | 12.3 units on a scale | Standard Deviation 5.3 |
p-value: 0.103ANOVA
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.
Time frame: Pre, week 8
Population: individuals who completed the measure at week 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relaxation Response (RR) | Self Compassion | week 8 | 3.2 units on a scale | Standard Deviation 0.72 |
| Relaxation Response (RR) | Self Compassion | pre | 2.9 units on a scale | Standard Deviation 0.67 |
| Mindfulness Based Stress Reduction (MBSR) | Self Compassion | week 8 | 3.6 units on a scale | Standard Deviation 0.7 |
| Mindfulness Based Stress Reduction (MBSR) | Self Compassion | pre | 3.1 units on a scale | Standard Deviation 0.6 |
Comparison: within group change from pre to week 8p-value: 0.06t-test, 2 sided
Comparison: within group change from pre to postp-value: <0.001t-test, 2 sided