StressNCT04722367
Being Present With Art: The Impact of Mindful Engagement With Art on Awareness and Connection
A study testing Art Pedagogy and Mindfulness in people with Stress, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to observe and measure the impact of mindfulness and art pedagogy on stress levels amongst students. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Art Pedagogy and Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2020to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to observe and measure the impact of mindfulness and art pedagogy on stress levels amongst students.
Read the 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.
- Conditions
- Stress
- Being tested
- Art Pedagogy and Mindfulness
- Keywords
- art pedagogy, mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art Pedagogy and MindfulnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Art Pedagogy and Mindfulness | Experimental | 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. Receives: Behavioral: Art Pedagogy and Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stress from Impact of Being Present with Art Intervention
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).
Measured: Baseline, 4 weeks
Change in mindfulness from Impact of Being Present with Art Intervention
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).
Measured: Baseline, 4 weeks
Change in Connectedness from Impact of Being Present with Art Intervention
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).
Measured: Baseline, 4 weeks
Secondary outcomes (3)
Change in Longitudinal Impact of Being Present with Art Intervention on Stress
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.
Measured: Baseline, 4 weeks, 8 weeks
Change in Longitudinal Impact of Being Present with Art Intervention on Mindfulness
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.
Measured: Baseline, 4 weeks, 8 weeks
Change in Longitudinal Impact of Being Present with Art Intervention on Connectedness
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.
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start28 Sep 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurie Santos, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722367
- Sponsor's protocol ID
- 2000028825
- Status last verified
- Jan 2021
- First submitted
- 19 Jan 2021
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Being Present With Art: The Impact of Mindful Engagement With Art on Awareness and Connection
- ClinicalTrials.gov ID
- NCT04722367
- Acronym / sponsor ID
- 2000028825
- Conditions
- Stress
- Keywords
- art pedagogy, mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to observe and measure the impact of mindfulness and art pedagogy on stress levels amongst students.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Art Pedagogy and Mindfulness | Experimental | Behavioral: Art Pedagogy and MindfulnessEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Art Pedagogy and MindfulnessEach 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. | Behavioural | Art Pedagogy and Mindfulness |
Primary outcome
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).
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).
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).
3 secondary outcomes
Change in Longitudinal Impact of Being Present with Art Intervention on Stress
Time frame: Baseline, 4 weeks, 8 weeks
Change in Longitudinal Impact of Being Present with Art Intervention on Mindfulness
Time frame: Baseline, 4 weeks, 8 weeks
Change in Longitudinal Impact of Being Present with Art Intervention on Connectedness
Time frame: Baseline, 4 weeks, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie Santos principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art Pedagogy and Mindfulness in people with Stress, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stress from Impact of Being Present with Art Intervention (time frame: Baseline, 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.