- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04632875
Online Trial of Meditation and Behavior
June 11, 2021 updated by: Georgetown University
Identifying Neural Correlates of Altruism
This study investigates how different types of meditation may affect behaviors and emotions.
The study is conducted entirely online and involves listening to 4-weeks of a guided meditation training.
The meditation involves either Loving-Kindness or Relaxation techniques.
The purpose of the study is to assess changes in behaviors and emotions using standard questionnaires, reports of real-world behavior, and online behavioral tasks.
The overarching goal is to help clarify how mind-body practices may improve some aspects of well-being.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
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
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20007
- Georgetown 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 to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Is a medically healthy individual
- Lives in the United States
- Has reliable internet access and the ability to join a Zoom video chat
Exclusion Criteria:
- Has experience with meditation or other mind-body practices
- Has a neurological disease
- Has a current psychiatric disorder
- Is on medication that affects the central nervous system (e.g. psychotropic drugs)
- Has recurrent or chronic pain
- Is pregnant or planning to become pregnant
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
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Loving-Kindness Meditation
4-week guided Loving-Kindness Meditation training (administered online).
|
Approximately 15-minute sessions are administered 6 days per week
Other Names:
|
Experimental: Relaxation Meditation
4-week guided Relaxation Meditation training (administered online).
|
Approximately 15-minute sessions are administered 6 days per week
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social functioning
Time Frame: 4-5 weeks
|
Participants will complete a questionnaire about their real-world social behaviors.
An aggregate score will be computed; higher scores will indicate better social functioning.
|
4-5 weeks
|
Affective responses
Time Frame: 4-5 weeks
|
Participants will perform a wall-sit test and responses will be measured using a 0-100 Visual Analog Scale of intensity.
|
4-5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychological well-being related to COVID-19
Time Frame: 4-5 weeks
|
Participants will complete a questionnaire related to the psychological impact of COVID-19 social distancing.
Higher scores will indicate worse psychological impact of COVID-19.
|
4-5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 4, 2020
Primary Completion (Actual)
June 10, 2021
Study Completion (Actual)
June 10, 2021
Study Registration Dates
First Submitted
November 10, 2020
First Submitted That Met QC Criteria
November 16, 2020
First Posted (Actual)
November 17, 2020
Study Record Updates
Last Update Posted (Actual)
June 14, 2021
Last Update Submitted That Met QC Criteria
June 11, 2021
Last Verified
November 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 2010-180-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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