- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04745364
Mindful Kala: Virtual Bharatanatyam Wellness Program for Students
June 17, 2021 updated by: Yale University
Mindful Kala: Investigating the Psychosocial Effects of a 4-Week Virtual Bharatanatyam Intervention for Students
In the current study, the researchers propose to develop and pilot test a Bharatanatyam (i.e.
Indian classical dance) program called Mindful Kala with the hopes of decreasing stress and increasing psychosocial well-being, mindfulness, cultural competence, and connectedness amongst a group of college students.
The investigators hope that this program can help students cultivate well-being during the challenging and stressful time of COVID-19.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Objectives:
- Evaluate the effects of the Mindful Kala program on outcomes of health-related measures such as mindfulness, stress, connectedness, and wellbeing amongst students. The investigators hypothesize that participants will experience fewer symptoms of stress, increased mindfulness, increased well-being, and increased connectedness.
- Evaluate the effects of the Mindful Kala program on changes in measures of cultural competence. The investigators hypothesize that the level of cultural competence will increase among the students.
- Develop and examine the feasibility and acceptability of a 4-week Mindful Kala program for college students.
Study Type
Interventional
Enrollment (Actual)
53
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
-
-
Connecticut
-
New Haven, Connecticut, United States, 06511
- Good Life Center, 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
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
- Is available for all of the designated Session One & Session Two dates and times
- Attends all of the designated Session One & Session Two dates and times
Exclusion Criteria:
- Not a Yale student
- Not 18 years of age or older
- Does not complete all survey measures
- Is not available for all of the designated Session One & Session Two dates and times
- Does not attend all of the designated Session One & Session Two dates and times
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Session One
Session One participants undergo the 4-week course from 2/21/2021 to 3/15/2021
|
The 4-week Mindful Kala program focuses on three components of Bharatanatyam: nritta (i.e.
technical movements), natya (i.e.
storytelling), and nritya (i.e. a combination of movements and narration; nritta + natya).
|
Experimental: Session Two
Session Two participants undergo the 4-week course from 3/22/2021 to 4/12/2021
|
The 4-week Mindful Kala program focuses on three components of Bharatanatyam: nritta (i.e.
technical movements), natya (i.e.
storytelling), and nritya (i.e. a combination of movements and narration; nritta + natya).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in stress from Mindful Kala Intervention
Time Frame: Baseline, 4 weeks
|
A primary objective of this study is to determine whether the Mindful Kala program 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 subjective well-being from Mindful Kala Intervention
Time Frame: Baseline, 4 weeks
|
A primary objective of this study is to determine whether the Mindful Kala program increases subjective well-being.
This will be measured by the PERMA Scale (min = 0; max = 10) which consists of 15 scale items.
The higher the score, the higher participant well-being.
Participants who received the intervention in Session One will be compared to the control (Session Two).
|
Baseline, 4 weeks
|
Change in mindful awareness from Mindful Kala Intervention
Time Frame: Baseline, 4 weeks
|
A primary objective of this study is to determine whether the Mindful Kala program increases mindful awareness of the present moment.
This will be measured by the State Mindfulness Scale for Physical Activity (min = 0; max = 4) which consists of 11 scale items.
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 cultural competence from Mindful Kala Intervention
Time Frame: Baseline, 4 weeks
|
A primary objective of this study is to determine whether the Mindful Kala program increases cultural competence.
This will be measured by the Cultural Competencies Self-Assessment Survey (min = 0; max = 5) which consists of 26 scale items.
The higher the score, the more culturally competent 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 Mindful Kala Intervention
Time Frame: Baseline, 4 weeks
|
A primary objective of this study is to determine whether the Mindful Kala program increases connectedness.
This will be measured by one question asking questions how connected they feel to the Yale community (min = 1; max = 5).
The higher the score, the more connected participants feel.
Participants who received the intervention in Session One will be compared to the control (Session Two).
|
Baseline, 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Longitudinal Impact of Mindful Kala on Stress
Time Frame: Baseline, 4 weeks, 8 weeks
|
A secondary objective of this study is to determine whether the Mindful Kala 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
|
Longitudinal Impact of Mindful Kala on Well-Being
Time Frame: Baseline, 4 weeks, 8 weeks
|
A secondary objective of this study is to determine whether the Mindful Kala intervention resulted in a longitudinal increase in well-being for Session One participants.
This outcome is measured by the PERMA Scale (min = 0; max = 10) which consists of 15 scale items.
The higher the score, the higher well-being participants have.
|
Baseline, 4 weeks, 8 weeks
|
Longitudinal Impact of Mindful Kala on Mindfulness
Time Frame: Baseline, 4 weeks, 8 weeks
|
A secondary objective of this study is to determine whether the Mindful Kala intervention resulted in a longitudinal increase in mindfulness for Session One participants.
This outcome is measured by the Mindfulness Scale for Physical Activity (min = 0; max = 4) which consists of 11 scale items.
The higher the score, the more mindful participants are.
|
Baseline, 4 weeks, 8 weeks
|
Longitudinal Impact of Mindful Kala on Cultural Competence
Time Frame: Baseline, 4 weeks, 8 weeks
|
A secondary objective of this study is to determine whether the Mindful Kala intervention resulted in a longitudinal increase in cultural competence for Session One participants.
This outcome is measured by the Cultural Competencies Self-Assessment Survey (min = 0; max = 5) which consists of 26 scale items.
The higher the score, the more culturally competent participants are.
|
Baseline, 4 weeks, 8 weeks
|
Longitudinal Impact of Mindful Kala on Connectedness
Time Frame: Baseline, 4 weeks, 8 weeks
|
A secondary objective of this study is to determine whether the Mindful Kala intervention resulted in a longitudinal increase in connectedness for Session One participants.
This outcome is measured by one question asking questions how connected they feel to the Yale community (min = 1; max = 5).
The higher the score, the more connected participants feel.
|
Baseline, 4 weeks, 8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility & Acceptability of Mindful Kala
Time Frame: 8 weeks
|
A tertiary objective of this study is to determine the feasibility & acceptability of the Mindful Kala program for college students.
This will be measured by asking participants the Feasibility & Acceptability scale (min = 1; max = 5) which consists of 2 scale items, 2 open-ended questions, and 4 multiple choice questions.
The higher the score on the scale items, the more participants enjoyed their experience in the Mindful Kala program and the more likely they are to practice Bharatanatyam on their own.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Laurie Santos, Doctorate, Yale University
- Principal Investigator: Elizabeth Goldfarb, Doctorate, Yale University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Khalsa SB, Butzer B. Yoga in school settings: a research review. Ann N Y Acad Sci. 2016 Jun;1373(1):45-55. doi: 10.1111/nyas.13025. Epub 2016 Feb 25.
- Koch SC, Riege RFF, Tisborn K, Biondo J, Martin L, Beelmann A. Effects of Dance Movement Therapy and Dance on Health-Related Psychological Outcomes. A Meta-Analysis Update. Front Psychol. 2019 Aug 20;10:1806. doi: 10.3389/fpsyg.2019.01806. eCollection 2019.
- Son C, Hegde S, Smith A, Wang X, Sasangohar F. Effects of COVID-19 on College Students' Mental Health in the United States: Interview Survey Study. J Med Internet Res. 2020 Sep 3;22(9):e21279. doi: 10.2196/21279.
- Tavormina R, Tavormina MGM. Overcoming Depression with Dance Movement Therapy: A Case Report. Psychiatr Danub. 2018 Nov;30(Suppl 7):515-520.
- Misra S, Le PD, Goldmann E, Yang LH. Psychological impact of anti-Asian stigma due to the COVID-19 pandemic: A call for research, practice, and policy responses. Psychol Trauma. 2020 Jul;12(5):461-464. doi: 10.1037/tra0000821. Epub 2020 Jun 11.
Helpful Links
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)
February 4, 2021
Primary Completion (Actual)
April 12, 2021
Study Completion (Actual)
April 12, 2021
Study Registration Dates
First Submitted
February 3, 2021
First Submitted That Met QC Criteria
February 3, 2021
First Posted (Actual)
February 9, 2021
Study Record Updates
Last Update Posted (Actual)
June 21, 2021
Last Update Submitted That Met QC Criteria
June 17, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2000029766
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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