Use of a Functional Neuroimaging Battery for the Evaluation of a Meditation Retreat (FETZER)

July 20, 2022 updated by: Thomas Jefferson University

Use of a Functional Neuroimaging Battery for the Evaluation of a Meditation

Over 2 decades scientists have been studying the effect on brain function from meditation practices. The purpose of this study is to measure the effect of a meditation retreat program on serotonin and dopamine transporter binding and changes in cerebral blood flow. The retreat program that will be followed is a week-long retreat called the Ignatian Retreat.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will utilize DaTscan single photon emission computed tomography (SPECT) and functional magnetic resonance imaging (fMRI) in healthy subjects within one month of entering the retreat. The study uses DaTscan to measure the effect on serotonin and dopamine transporter binding, and functional magnetic resonance imaging (fMRI) to measure the effect on cerebral blood flow. The Ignatian Retreat is a weeklong retreat which involves meditation and prayer.

Additionally, study participants will complete a variety of questionnaires and scales to measure psychological and spirituality states. The scans and questionnaires will be completed before and after the participant has completed the retreat. The ultimate goal of the study is to analyze and compare pre and post imaging and neuropsychological and spirituality changes in healthy controls who participate in this retreat.

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

At present, study participants are recruited from a variety of meditation programs and through the Center of Integrative Medicine. All subjects will be healthy adults.

Description

Inclusion Criteria:

  • Able to give informed consent and willing to complete the study.
  • Willing to undergo the full imaging procedures.
  • Women of childbearing potential with a negative serum pregnancy test.

Exclusion Criteria:

  • Any neurological or psychiatric disorders, including drug or alcohol abuse, that may interfere with cerebral blood flow as determined by the principal investigator.
  • Any medical conditions that may interfere with cerebral blood flow as determined by the principal investigator.
  • Currently taking medication that might affect cerebral blood flow (i.e. antidepressants, antipsychotics, anxiolytics, benzodiazepines, sedatives, antiseizure medications)
  • Subject is unable or unwilling to lie still in the scanner (i.e. due to claustrophobia or weight > 350 pounds)
  • Subject has metal in their body or other reason that they cannot undergo magnetic resonance imaging.
  • Previous brain surgery or intracranial abnormalities they may complicate interpretation of the brain scans. (e.g. stroke, tumor, vascular abnormality).
  • Pregnancy
  • Allergy to iodine or shellfish.
  • Concurrent participation in another research protocol that might affect the outcome of this study as determined by the principle Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Subjects
Healthy subjects will attend the weeklong meditation retreat.
Weeklong retreat which includes meditation and prayer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Single Photon Emission Computed Tomography (SPECT) Imaging (DaTScan)
Time Frame: Within one month of the retreat
To detect changes in dopamine and serotonin before and after a meditation retreat program in serotonin transporter and dopamine transporter binding.
Within one month of the retreat

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional MRI
Time Frame: Within one month of the retreat
To detect changes in cerebral blood flow before and after a meditation retreat program.
Within one month of the retreat

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speilberger State Trait Anxiety Inventory (STAI)
Time Frame: Within one month of the retreat
This validated questionnaire will be used as one of the evaluation questionnaires for the study. The Speilberger State Trait Anxiety Inventory (STAI) contains a total of 40 questions, half of which relate to the way subjects are feeling at the moment and half of which ask them to describe how they usually feel.
Within one month of the retreat
Profile of Moods Scale (POMS)
Time Frame: Within one month of the retreat
The Profile of Mood States (POMS) is a validated questionnaire of 65 single word items that asks "How have you been feeling in the past week including today." The subjects will select their response to each word that describes a mood or feeling on a Likert scale from 1= Not at All, 2= A Little, 3=Moderately, 4=Quite a lot, to 5=Extremely. The responses are scored to generate values for Tension, Anger, Confusion, Depression and Vigor. The higher scores indicate a greater presence of that mood or state.
Within one month of the retreat
Beck Depression Inventory (Beck 1972)
Time Frame: Within one month of the retreat
This validated questionnaire will be used as one of the evaluation questionnaires for the study. The Beck Depression Inventory (Beck 1972) is a standard 21 item questionnaire probing cognitive and somatic symptoms of depression. The higher scores indicate a greater presence of depression.
Within one month of the retreat
Standard Form-12 (SF-12)
Time Frame: Within one month of the retreat
This 12-item validated questionnaire will be used as one of the evaluation questionnaires for the study. The subjects will select their response to each word that describes a mood or feeling on a Likert scale.
Within one month of the retreat
Hood Mysticism Scale (Lifetime)
Time Frame: Within one month of the retreat
This validated scale will be used as one of the evaluation questionnaires for the study. Items are rated on a five-point scale with negatively worded items reverse scored. The responses are scored to generate values for Extrovertive Mysticism, Religious Interpretation, and Introvertive Mysticism.
Within one month of the retreat
Brief Multidimensional Measure of Religiousness/Spirituality
Time Frame: Within one month of the retreat
This 30-item validated questionnaire will be used as one of the evaluation questionnaires for the study. The responses are scored to generate values for Suffering, Positing Sharing, Crying, Emotional Attention, Feel for Others, and Emotional Contagion.
Within one month of the retreat
Gratitude Questionnaire
Time Frame: Within one month of the retreat
This validated questionnaire will be used as one of the evaluation questionnaires for the study. The subjects will select their response on a Likert scale. The higher scores indicate a greater sense of gratitude.
Within one month of the retreat
Daily Spiritual Experience Scale
Time Frame: Within one month of the retreat
This validated questionnaire will be used as one of the evaluation questionnaires for the study. This assessment measures ordinary, or daily, spiritual experiences.
Within one month of the retreat
The Assessment of Spirituality and Religious Sentiments (ASPIRES )
Time Frame: Within one month of the retreat
This validated questionnaire will be used as one of the evaluation questionnaires for the study. This assessment measures Religious sentiments and Spiritual Transcendence.
Within one month of the retreat
Index of Core Spiritual Experiences (INSPIRIT)
Time Frame: Within one month of the retreat
This validated questionnaire will be used as one of the evaluation questionnaires for the study to evaluate the presence or frequency of certain religions.
Within one month of the retreat
Functional Assessment of Chronic Illness Therapy Spiritual Well-Being (FACIT-Sp-12)
Time Frame: Within one month of the retreat
This validated questionnaire will be used as one of the evaluation questionnaires for the study. The 12-item assessment is used to measure spiritual well-being by asking patients to describe aspects of spirituality and/or religious faith that contribute to health related quality of life.
Within one month of the retreat
Cloninger Self-Transcendence Scale
Time Frame: Within one month of the retreat
This validated questionnaire will be used as one of the evaluation questionnaires for the study. The subjects will select their response on a Likert scale. The higher scores indicate a greater presence to self-transcendence and well being.
Within one month of the retreat
Five Facet Mindfulness Questionnaire
Time Frame: Within one month of the retreat
This validated questionnaire will be used as one of the evaluation questionnaires for the study.The analysis yielded five factors that appear to represent elements of mindfulness as it is currently conceptualized.The five facets are observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
Within one month of the retreat

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2012

Primary Completion (Actual)

March 2, 2017

Study Completion (Actual)

March 2, 2017

Study Registration Dates

First Submitted

February 6, 2015

First Submitted That Met QC Criteria

May 11, 2015

First Posted (Estimate)

May 14, 2015

Study Record Updates

Last Update Posted (Actual)

July 25, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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