Exploratory Analysis of the Relaxation Response (RR) and Mindfulness Based Stress Reduction (MBSR) for Stress Reduction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Perceived Stress Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Program A - Relaxation Response (RR)
One of the 2 stress reduction courses
Intervention: RR (Behavioral)
Program B - Mindfullness-based stress reduction (MBSR)
One of the 2 stress reduction courses
Intervention: MBSR (Behavioral)
Outcomes
Primary Outcomes
Perceived Stress Scale
Time Frame: 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
Time Frame: 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.
Brain Activity (fMRI) During the Body Scan Meditation
Time Frame: 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
Time Frame: 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.
Anxiety Severity Index
Time Frame: 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 Outcomes
- Self Compassion(Pre, week 8)
Investigators
Sara W Lazar
Associate Research Scientist
Massachusetts General Hospital