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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04745364
Other study ID # 2000029766
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 4, 2021
Est. completion date April 12, 2021

Study information

Verified date June 2021
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date April 12, 2021
Est. primary completion date April 12, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
United States Good Life Center, Yale University New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Tavormina R, Tavormina MGM. Overcoming Depression with Dance Movement Therapy: A Case Report. Psychiatr Danub. 2018 Nov;30(Suppl 7):515-520. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Feasibility & Acceptability of Mindful Kala 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
Primary Change in stress from Mindful Kala Intervention 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
Primary Change in subjective well-being from Mindful Kala Intervention 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
Primary Change in mindful awareness from Mindful Kala Intervention 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
Primary Change in cultural competence from Mindful Kala Intervention 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
Primary Change in connectedness from Mindful Kala Intervention 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 Longitudinal Impact of Mindful Kala on Stress 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
Secondary Longitudinal Impact of Mindful Kala on Well-Being 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
Secondary Longitudinal Impact of Mindful Kala on Mindfulness 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
Secondary Longitudinal Impact of Mindful Kala on Cultural Competence 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
Secondary Longitudinal Impact of Mindful Kala on Connectedness 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
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