Quality of LifeNCT04745364
Mindful Kala: Virtual Bharatanatyam Wellness Program for Students
A study testing A 4-week Bharatanatyam course from the organization Mindful Kala in people with Quality of Life and Cultural Competence, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Cultural Competence, Stress
- What is being tested?
- A 4-week Bharatanatyam course from the organization Mindful Kala
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2021to 12 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Good Life Center, Yale University
New Haven, Connecticut, 06511
About this study
Official title: 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.
Read the 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.
- Conditions
- Quality of Life, Cultural Competence, Stress
- Being tested
- A 4-week Bharatanatyam course from the organization Mindful Kala
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A 4-week Bharatanatyam course from the organization Mindful KalaBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Session One | Experimental | Session One participants undergo the 4-week course from 2/21/2021 to 3/15/2021 Receives: 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 Receives: Behavioral: A 4-week Bharatanatyam course from the organization Mindful Kala |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline, 4 weeks
Secondary outcomes (5)
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.
Measured: Baseline, 4 weeks, 8 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start4 Feb 2021
- Primary completion12 Apr 2021
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurie Santos, Doctorate, Principal investigator, Yale UniversityElizabeth Goldfarb, Doctorate, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745364
- Sponsor's protocol ID
- 2000029766
- Status last verified
- Jun 2021
- First submitted
- 3 Feb 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26919395Koch 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.
PubMed 31481910Son 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.
PubMed 32805704Tavormina R, Tavormina MGM. Overcoming Depression with Dance Movement Therapy: A Case Report. Psychiatr Danub. 2018 Nov;30(Suppl 7):515-520.
PubMed 30439838Misra 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.
PubMed 32525390
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Kala: Investigating the Psychosocial Effects of a 4-Week Virtual Bharatanatyam Intervention for Students
- ClinicalTrials.gov ID
- NCT04745364
- Acronym / sponsor ID
- 2000029766
- Conditions
- Quality of Life, Cultural Competence, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Session One | Experimental | Behavioral: A 4-week Bharatanatyam course from the organization Mindful KalaSession One participants undergo the 4-week course from 2/21/2021 to 3/15/2021 |
| Session Two | Experimental | Behavioral: A 4-week Bharatanatyam course from the organization Mindful KalaSession Two participants undergo the 4-week course from 3/22/2021 to 4/12/2021 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A 4-week Bharatanatyam course from the organization Mindful KalaThe 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). | Behavioural | Session One, Session Two |
Primary outcome
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).
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).
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).
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).
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).
5 secondary outcomes
Longitudinal Impact of Mindful Kala on Stress
Time frame: Baseline, 4 weeks, 8 weeks
Longitudinal Impact of Mindful Kala on Well-Being
Time frame: Baseline, 4 weeks, 8 weeks
Longitudinal Impact of Mindful Kala on Mindfulness
Time frame: Baseline, 4 weeks, 8 weeks
Longitudinal Impact of Mindful Kala on Cultural Competence
Time frame: Baseline, 4 weeks, 8 weeks
Longitudinal Impact of Mindful Kala on Connectedness
Time frame: Baseline, 4 weeks, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Background: PubMed 26919395Khalsa 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.
- Background: PubMed 31481910Koch 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.
- Background: PubMed 32805704Son 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.
- Background: PubMed 30439838Tavormina R, Tavormina MGM. Overcoming Depression with Dance Movement Therapy: A Case Report. Psychiatr Danub. 2018 Nov;30(Suppl 7):515-520.
- Background: PubMed 32525390Misra 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie Santos, Doctorate principal investigator
Yale University
Elizabeth Goldfarb, Doctorate principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A 4-week Bharatanatyam course from the organization Mindful Kala in people with Quality of Life and Cultural Competence, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stress from Mindful Kala Intervention (time frame: Baseline, 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04745364, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.