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

Healthy Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02443766
• Other study ID #: 11G.488
• Status: Completed
• Start date: January 5, 2012
• Est. completion date: March 2, 2017

Study information

• Verified date: July 2022
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 2, 2017
• Est. primary completion date: March 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Meditation Retreat
Weeklong retreat which includes meditation and prayer.

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Speilberger State Trait Anxiety Inventory (STAI)	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
Other	Profile of Moods Scale (POMS)	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
Other	Beck Depression Inventory (Beck 1972)	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
Other	Standard Form-12 (SF-12)	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
Other	Hood Mysticism Scale (Lifetime)	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
Other	Brief Multidimensional Measure of Religiousness/Spirituality	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
Other	Gratitude Questionnaire	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
Other	Daily Spiritual Experience Scale	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
Other	The Assessment of Spirituality and Religious Sentiments (ASPIRES )	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
Other	Index of Core Spiritual Experiences (INSPIRIT)	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
Other	Functional Assessment of Chronic Illness Therapy Spiritual Well-Being (FACIT-Sp-12)	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
Other	Cloninger Self-Transcendence Scale	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
Other	Five Facet Mindfulness Questionnaire	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
Primary	Single Photon Emission Computed Tomography (SPECT) Imaging (DaTScan)	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	functional MRI	To detect changes in cerebral blood flow before and after a meditation retreat program.	Within one month of the retreat

External Links

•   Publication from study results