- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02443766
Use of a Functional Neuroimaging Battery for the Evaluation of a Meditation Retreat (FETZER)
Use of a Functional Neuroimaging Battery for the Evaluation of a Meditation
Study Overview
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy Subjects
Healthy subjects will attend the weeklong meditation retreat.
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Weeklong retreat which includes meditation and prayer.
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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
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To detect changes in dopamine and serotonin before and after a meditation retreat program in serotonin transporter and dopamine transporter binding.
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Within one month of the retreat
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
functional MRI
Time Frame: Within one month of the retreat
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To detect changes in cerebral blood flow before and after a meditation retreat program.
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Within one month of the retreat
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speilberger State Trait Anxiety Inventory (STAI)
Time Frame: Within one month of the retreat
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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.
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Within one month of the retreat
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Profile of Moods Scale (POMS)
Time Frame: Within one month of the retreat
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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.
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Within one month of the retreat
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Beck Depression Inventory (Beck 1972)
Time Frame: Within one month of the retreat
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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.
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Within one month of the retreat
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Standard Form-12 (SF-12)
Time Frame: Within one month of the retreat
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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.
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Within one month of the retreat
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Hood Mysticism Scale (Lifetime)
Time Frame: Within one month of the retreat
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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.
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Within one month of the retreat
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Brief Multidimensional Measure of Religiousness/Spirituality
Time Frame: Within one month of the retreat
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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.
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Within one month of the retreat
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Gratitude Questionnaire
Time Frame: Within one month of the retreat
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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.
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Within one month of the retreat
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Daily Spiritual Experience Scale
Time Frame: Within one month of the retreat
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This validated questionnaire will be used as one of the evaluation questionnaires for the study.
This assessment measures ordinary, or daily, spiritual experiences.
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Within one month of the retreat
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The Assessment of Spirituality and Religious Sentiments (ASPIRES )
Time Frame: Within one month of the retreat
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This validated questionnaire will be used as one of the evaluation questionnaires for the study.
This assessment measures Religious sentiments and Spiritual Transcendence.
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Within one month of the retreat
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Index of Core Spiritual Experiences (INSPIRIT)
Time Frame: Within one month of the retreat
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This validated questionnaire will be used as one of the evaluation questionnaires for the study to evaluate the presence or frequency of certain religions.
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Within one month of the retreat
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Functional Assessment of Chronic Illness Therapy Spiritual Well-Being (FACIT-Sp-12)
Time Frame: Within one month of the retreat
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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.
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Within one month of the retreat
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Cloninger Self-Transcendence Scale
Time Frame: Within one month of the retreat
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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.
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Within one month of the retreat
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Five Facet Mindfulness Questionnaire
Time Frame: Within one month of the retreat
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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.
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Within one month of the retreat
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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