- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06513871
Evaluating Social Perception Dynamics
Evaluating the Impact of Community-Based Mindfulness and Musical Programs on Psychiatric Measures, Social Perception Tasks 2d.
Mental health vulnerability due to stress is increased in People of African Descent (PADs) in America due to disproportionate effects of racism, poverty, education, and criminal justice sentencing. Various meditation and mindfulness approaches have provided evidence of measured reductions in multiple negative dimensions of stress. However, the majority of these studies do not have an adequate representation of PADs or other marginalized groups and are not designed to be culturally relevant or community based. Music has been shown to alleviate multiple symptoms of stress and has been shown to be a preferred and effective support for meditation and mindfulness. However, its role in stress management in PADs engaged in meditation or mindfulness is seldom studied. This study aims to evaluate the effects of a virtual, community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19.
Component 2d. Social Perception Tasks: Participants may be asked to take part in social perception tasks in which they will be asked to indicate their social perception and connection felt with various partners.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators also propose a study to investigate the effects of communal drumming in reducing anxiety and increasing connectedness within drum circle community. Investigators hypothesize that these intervention will lead to reductions in scores on stress scales and will provide preliminary data for studies evaluating these types of community programs as an adjunct to the standard of care.
Paradigms will be designed such that participants experience speed-dating like interactions with individuals in which they are not allowed to verbally communicate. After silently interacting with each partner, subjects will be prompted to answer survey questions about their perceptions of their partner and their interaction. This task will take place in a variety of settings.
This task was developed to quantify group dynamics. Participants that are enrolled and consented in a study are given a participant ID number. Each participant sits 2 feet across from another participant. They are paired with that participant for 30 seconds. They are instructed that they can look freely across at their own will. After 30 seconds they are asked to answer the following questions on a Likert scale 1-7 about the interaction with the other participant:
What is your partner's ID? How connected do you feel to this partner? (very unconnected-very connected) How approachable do you think this person is? (very unapproachable-very approachable) How likely is this person to be in your socioeconomic class? (very unlikely-very likely) How likely is this person to share your political views? (very unlikely-very likely) How willing are you to discuss a controversial subject with this partner? (very unwilling - very willing) How willing are you to compromise to solve a complex problem with this partner? (very unwilling - very willing)
Following this they are paired with another participant in the group and complete the same questions. This continues until they have been matched with all other participants.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06515
- BLOOM
-
New Haven, Connecticut, United States, 06520
- Musical Intervention Studios
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ages 16 and older
Exclusion Criteria:
- ages 15 and younger
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Component 2d. Social Perception Tasks
Participants will take part in social perception tasks in speed-dating like interactions with individuals in which they are not allowed to verbally communicate.
After silently interacting with each partner, subjects will be prompted to answer survey questions about their perceptions of their partner and their interaction.
This task will take place in a variety of settings.
|
social perception tasks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean score individual subjective rating of social connection during session
Time Frame: baseline on day of study and 5 minutes after intervention
|
Rating of subjective connectedness will be assessed using a Likert scale with total score range from 1-5, with higher scores indicating more connectedness.
|
baseline on day of study and 5 minutes after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean score group subjective rating of social connection post session
Time Frame: baseline on day of study and 5 minutes after intervention
|
Rating of subjective connectedness will be assessed using a Likert scale with total score range from 1-5, with higher scores indicating more connectedness.
|
baseline on day of study and 5 minutes after intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: AZA Allsop, MD, PhD, Yale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000028866_d
- 2R25MH071584-11 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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