NCT04722367

Brief Summary

The purpose of this study is to observe and measure the impact of mindfulness and art pedagogy on stress levels amongst students.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 19, 2021

Last Update Submit

January 19, 2021

Conditions

Keywords

art pedagogymindfulness

Outcome Measures

Primary Outcomes (3)

  • 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).

    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).

    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).

    Baseline, 4 weeks

Secondary Outcomes (3)

  • Change in Longitudinal Impact of Being Present with Art Intervention on Stress

    Baseline, 4 weeks, 8 weeks

  • Change in Longitudinal Impact of Being Present with Art Intervention on Mindfulness

    Baseline, 4 weeks, 8 weeks

  • Change in Longitudinal Impact of Being Present with Art Intervention on Connectedness

    Baseline, 4 weeks, 8 weeks

Other Outcomes (3)

  • Pre vs. Post-Session Check-In: Investigating 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

    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

    Session One: Week 1, Week 2, Week 3, Week 4; Session Two: Week 5, Week 6, Week 7, Week 8

Study Arms (1)

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.

Behavioral: Art Pedagogy and Mindfulness

Interventions

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.

Art Pedagogy and Mindfulness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Laurie Santos

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 25, 2021

Study Start

September 28, 2020

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

January 25, 2021

Record last verified: 2021-01

Locations