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Mindful Kala: Virtual Bharatanatyam Wellness Program for Students

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04745364
Recruitment Status : Completed
First Posted : February 9, 2021
Last Update Posted : June 21, 2021
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Quality of Life Cultural Competence Stress Behavioral: A 4-week Bharatanatyam course from the organization Mindful Kala Not Applicable

Detailed Description:

Objectives:

  1. 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.
  2. 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.
  3. Develop and examine the feasibility and acceptability of a 4-week Mindful Kala program for college students.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study uses a waitlist control design. The "call for participants" will be included in the Good Life Center newsletters sent the week of February 8th (if possible) and February 15th. Students will register by 11:59 pm on Friday, February 19th . If they are eligible, within the registration survey, participants will then progress to baseline assessments of stress, well-being, mindful awareness, cultural competence, and feelings of connectedness to the Yale community. Participants will be randomly assigned to either Session One or Session Two.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Mindful Kala: Investigating the Psychosocial Effects of a 4-Week Virtual Bharatanatyam Intervention for Students
Actual Study Start Date : February 4, 2021
Actual Primary Completion Date : April 12, 2021
Actual Study Completion Date : April 12, 2021

Arm Intervention/treatment
Experimental: Session One
Session One participants undergo the 4-week course from 2/21/2021 to 3/15/2021
Behavioral: A 4-week Bharatanatyam course from the organization Mindful Kala
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
Behavioral: A 4-week Bharatanatyam course from the organization Mindful Kala
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).




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04745364


Locations
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United States, Connecticut
Good Life Center, Yale University
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Laurie Santos, Doctorate Yale University
Principal Investigator: Elizabeth Goldfarb, Doctorate Yale University
Additional Information:
Publications:
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04745364    
Other Study ID Numbers: 2000029766
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: June 21, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No