Being Present With Art: The Impact of Mindful Engagement With Art on Awareness and Connection

January 19, 2021 updated by: Yale University
The purpose of this study is to observe and measure the impact of mindfulness and art pedagogy on stress levels amongst students.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study uses a waitlist control design. Participants will be randomly assigned to either session one or session two.

Regardless if they are registered for Session One or Session Two, each participant will be invited to self-report their stress levels, feelings of being aware of the present moment, and feelings of connection and belonging on a weekly basis. There will be a follow-up survey at the end of Session One and Session Two to compare changes between participants who have already received the intervention and those who have not. In this way, Session One participants act as a control group. This follow-up survey will be utilized once again after Session Two finishes in order to examine whether there is a lasting impact on Session One participants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Yale student
  • 18 years of age or older
  • Must complete all survey measures
  • Must be available Mondays 5-6 pm EST in October and November

Exclusion Criteria:

  • Not a Yale student
  • Not 18 years of age or older
  • Does not complete all survey measures
  • Not available Mondays 5-6 pm EST in October and November

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Art Pedagogy and Mindfulness
Each participant will take part in four 1-hour sessions. Study activities include guided meditation, close looking, drawing, writing, and storytelling. Each session will begin with a guided meditation that is followed by an exercise inspired by two works of art, and end with an opportunity for students to reflect on the experience.
Behavioral: Art Pedagogy and Mindfulness
Each participant will take part in four 1-hour sessions. Study activities include guided meditation, close looking, drawing, writing, and storytelling. Each session will begin with a guided meditation that is followed by an exercise inspired by two works of art, and end with an opportunity for students to reflect on the experience.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in stress from Impact of Being Present with Art Intervention
Time Frame: Baseline, 4 weeks
A primary objective of this study is to determine whether mindful engagement with art reduces student stress levels. This will be measured by the Perceived Stress Scale (min = 0; max = 4) which consists of 10 scale items. The higher the score, the more likely participants are stressed. Participants who received the intervention in Session One will be compared to the control (Session Two).
Baseline, 4 weeks
Change in mindfulness from Impact of Being Present with Art Intervention
Time Frame: Baseline, 4 weeks
A primary objective of this study is to determine whether mindful engagement with art increases mindful awareness in students. This will be measured by the Mindful Awareness Scale (min = 1; max = 6) which includes 15 questions. The higher the score, the more mindful participants are. Participants who received the intervention in Session One will be compared to the control (Session Two).
Baseline, 4 weeks
Change in Connectedness from Impact of Being Present with Art Intervention
Time Frame: Baseline, 4 weeks
A primary objective of this study is to determine whether mindful engagement with art increases feelings of connectedness in students. This will be measured by a scale created by the investigators to ask participants how connected they feel to the Yale community (min = 1; max = 5). This scale involves one question. The higher the score, the more connected participants feel to the Yale community. Participants who received the intervention in Session One will be compared to the control (Session Two).
Baseline, 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Longitudinal Impact of Being Present with Art Intervention on Stress
Time Frame: Baseline, 4 weeks, 8 weeks
A secondary objective of this study is to determine whether the Being Present with Art intervention resulted in a longitudinal decrease in stress for Session One participants. This outcome is measured by the Perceived Stress Scale (min = 0; max = 4) which consists of 10 scale items. The higher the score, the more stressed participants are.
Baseline, 4 weeks, 8 weeks
Change in Longitudinal Impact of Being Present with Art Intervention on Mindfulness
Time Frame: Baseline, 4 weeks, 8 weeks
A secondary objective of this study is to determine whether the Being Present with Art intervention resulted in a longitudinal increase in mindfulness for Session One participants. This outcome is measured by the Mindful Awareness Scale (min = 1; max = 6) which consists of 15 scale items. The higher the score, the more mindful participants are.
Baseline, 4 weeks, 8 weeks
Change in Longitudinal Impact of Being Present with Art Intervention on Connectedness
Time Frame: Baseline, 4 weeks, 8 weeks
A secondary objective of this study is to determine whether the Being Present with Art intervention resulted in a longitudinal increase in connectedness for Session One participants. This outcome is measured by connectedness scale we created for the purpose of this study (min = 1; max = 5) which consists of one question. Higher scores indicate increased participant feelings of connectedness to the Yale community.
Baseline, 4 weeks, 8 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pre vs. Post-Session Check-In: Investigating Stress
Time Frame: Session One: Week 1, Week 2, Week 3, Week 4; Session Two: Week 5, Week 6, Week 7, Week 8
Session One and Session Two participants each attended 4 consecutive weeks of the Being Present with Art programming. The investigators wanted to know whether stress measures before vs. after any one of these four sessions resulted in decreased stress for both Session One and Session Two participants. This was measured by asking students one question about how stressed they currently felt (min = 0; max = 4). Higher scores indicate increased participant stress.
Session One: Week 1, Week 2, Week 3, Week 4; Session Two: Week 5, Week 6, Week 7, Week 8
Pre vs. Post-Session Check-In: Investigating Mindfulness
Time Frame: Session One: Week 1, Week 2, Week 3, Week 4; Session Two: Week 5, Week 6, Week 7, Week 8
Session One and Session Two participants each attended 4 consecutive weeks of the Being Present with Art programming. The investigators wanted to know whether mindfulness measures before vs. after any one of these four sessions resulted in increased mindfulness for both Session One and Session Two participants. This was measured by asking students one question about how aware of the present moment they currently felt (min = 0; max = 4). Higher scores indicate increased mindful awareness.
Session One: Week 1, Week 2, Week 3, Week 4; Session Two: Week 5, Week 6, Week 7, Week 8
Pre vs. Post-Session Check-In: Investigating Connectedness
Time Frame: Session One: Week 1, Week 2, Week 3, Week 4; Session Two: Week 5, Week 6, Week 7, Week 8
Session One and Session Two participants each attended 4 consecutive weeks of the Being Present with Art programming. The investigators wanted to know whether connectedness measures before vs. after any one of these four sessions resulted in increased connectedness for both Session One and Session Two participants. This was measured by asking students one question about how connected to the Yale community they currently felt (min = 0; max = 4). Higher scores indicate increased feelings of connectedness.
Session One: Week 1, Week 2, Week 3, Week 4; Session Two: Week 5, Week 6, Week 7, Week 8

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laurie Santos, Yale University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000028825

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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