NCT04745364

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable quality-of-life

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable quality-of-life

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

February 4, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2021

Completed
Last Updated

June 21, 2021

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

February 3, 2021

Last Update Submit

June 17, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (5)

  • Longitudinal Impact of Mindful Kala on Stress

    Baseline, 4 weeks, 8 weeks

  • Longitudinal Impact of Mindful Kala on Well-Being

    Baseline, 4 weeks, 8 weeks

  • Longitudinal Impact of Mindful Kala on Mindfulness

    Baseline, 4 weeks, 8 weeks

  • Longitudinal Impact of Mindful Kala on Cultural Competence

    Baseline, 4 weeks, 8 weeks

  • Longitudinal Impact of Mindful Kala on Connectedness

    Baseline, 4 weeks, 8 weeks

Other Outcomes (1)

  • Feasibility & Acceptability of Mindful Kala

    8 weeks

Study Arms (2)

Session One

EXPERIMENTAL

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

Session Two

EXPERIMENTAL

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

Interventions

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).

Session OneSession Two

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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Good Life Center, Yale University

New Haven, Connecticut, 06511, United States

Location

Related 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.

    PMID: 26919395BACKGROUND
  • 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.

    PMID: 31481910BACKGROUND
  • 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.

    PMID: 32805704BACKGROUND
  • Tavormina R, Tavormina MGM. Overcoming Depression with Dance Movement Therapy: A Case Report. Psychiatr Danub. 2018 Nov;30(Suppl 7):515-520.

    PMID: 30439838BACKGROUND
  • 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.

    PMID: 32525390BACKGROUND

Related Links

Study Officials

  • Laurie Santos, Doctorate

    Yale University

    PRINCIPAL INVESTIGATOR
  • Elizabeth Goldfarb, Doctorate

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 9, 2021

Study Start

February 4, 2021

Primary Completion

April 12, 2021

Study Completion

April 12, 2021

Last Updated

June 21, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations