Comparison of Two Behavioral Treatments for Stress Reduction

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00625807
• Other study ID #: R21AT003425-01A2
• Secondary ID: R21AT003425-01A2
• Status: Completed
• Phase: N/A
• Start date: January 2008
• Est. completion date: October 2009

Study information

• Verified date: July 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress

Intervention

Behavioral:
• RR
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
• MBSR
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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Week 8
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.	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	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.	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.	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.	Pre, week 8