StressNCT00625807

Comparison of Two Behavioral Treatments for Stress Reduction

A study testing RR and MBSR in people with Stress, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 25 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Stress
What is being tested?: RR and MBSR
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Jan 2008to Oct 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02119

Other trials in United States

About this study

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

Conditions: Stress
Being tested: RR, MBSR
Keywords: Stress, meditation, stress reduction, fMRI, behavioral
Medical subject headings: Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RRBehavioural
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
MBSRBehavioural
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

Study groups in NCT00625807
Study group	Role	What they receive
Program A - Relaxation Response (RR)	Active comparator	One of the 2 stress reduction courses Receives: Behavioral: RR
Program B - Mindfullness-based stress reduction (MBSR)	Active comparator	One of the 2 stress reduction courses Receives: Behavioral: MBSR

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Pre, 8 weeks

Secondary outcomes (1)

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.
Measured: Pre, week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Oct 2009

First posted28 Feb 2008 (estimated)
Study startJan 2008
Primary completionOct 2009
Study completionOct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for StressStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00625807
Sponsor's protocol ID: R21AT003425-01A2
Other IDs: R21AT003425-01A2, SL1
Status last verified: Jul 2018
First submitted: 26 Feb 2008
Last updated: 7 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stress trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploratory Analysis of the Relaxation Response (RR) and Mindfulness Based Stress Reduction (MBSR) for Stress Reduction
ClinicalTrials.gov ID: NCT00625807
Acronym / sponsor ID: R21AT003425-01A2
Conditions: Stress
Keywords: Stress, meditation, stress reduction, fMRI, behavioral
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: Jan 2008
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 28 Feb 2008 (estimated)
Results: Posted 7 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Program A - Relaxation Response (RR)	Active comparator	Behavioral: RROne of the 2 stress reduction courses
Program B - Mindfullness-based stress reduction (MBSR)	Active comparator	Behavioral: MBSROne of the 2 stress reduction courses

Who may qualify

Ages: 25 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

Psychiatric medications
Significant medical or psychological illness
Metalic implants (such as a pacemaker or artificial joints) that are not MRI compatible.
Claustrophobia
Pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RRA 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	Behavioural	Program A - Relaxation Response (RR)
MBSRA 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	Behavioural	Program B - Mindfullness-based stress reduction (MBSR)

Primary outcome

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.
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.
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.

1 secondary outcome

Self Compassion
Time frame: Pre, week 8

Results and safety

Results posted to the registry on 7 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Relaxation Response (RR)	22	20
Mindfulness Based Stress Reduction (MBSR)	28	20

Primary outcome: Brain Activity (fMRI) During the Body Scan Meditation

Time frame: Week 8. Number. Unit: voxels

Measure	Relaxation Response (RR) n = 16	Mindfulness Based Stress Reduction (MBSR) n = 18
Value	74	82

Primary outcome: Five Facet Mindfulness Questionnaire

Time frame: Pre, 8 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Relaxation Response n = 20	MBSR n = 20
Pre	130.8 (17.7)	125.3 (17.7)
week 8	144.2 (20.6)	139.1 (21.1)

Relaxation Response vs MBSR: p > 0.1, ANOVA

Population analysed: Individuals who completed at least one measure at post

Primary outcome: Perceived Stress Scale

Time frame: Pre, 8 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Relaxation Response n = 20	MBSR n = 20
Pre	14.1 (6.6)	18.4 (6.7)
week 8	11.3 (5.5)	12.3 (5.3)

Relaxation Response vs MBSR: p = 0.103, ANOVA

Population analysed: Individuals who completed at least one measure at post

Primary outcome: Penn State Worry Questionnaire

Time frame: Pre, 8 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Relaxation Response n = 19	MBSR n = 18
Pre	42.6 (11.9)	50.5 (13.1)
week 8	37.7 (10.1)	44.3 (12.0)

Relaxation Response: p = .022, t-test, 2 sided
MBSR: p <.001, t-test, 2 sided

Population analysed: Individuals who completed at least one measure at post

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Relaxation Response	0 of 22 (0%)	0 of 22 (0%)	0 of 22
MBSR	0 of 28 (0%)	0 of 28 (0%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sara Lazar, PhD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing RR and MBSR in people with Stress, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain Activity (fMRI) During the Body Scan Meditation (time frame: Week 8). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00625807.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.