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Completed

NCT Number: NCT02443766

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

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Meditation Retreat

Other

Weeklong retreat which includes meditation and prayer.

Primary outcomes

  1. 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.

Secondary outcomes

  1. functional MRI

    Time frame: Within one month of the retreat

    To detect changes in cerebral blood flow before and after a meditation retreat program.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

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

Acronym: FETZER

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
May 14, 2015
Registry last updated
Jul 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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