Improving Physical, Mental, and Spiritual Health in Faith-Based Settings Through Creating a Healthy Culture in Bronx, NY

Mental Health Issue Clinical Trial

Official title:

Improving Physical, Mental, and Spiritual Health in Faith-Based Settings Through Creating a Healthy Culture in Bronx, NY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04353427
• Other study ID #: 19-01617
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: March 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed study "Improving Physical, Mental, and Spiritual Health in Faith- Based Settings through Creating a Healthy Culture in Bronx, NY" aims to assess the efficacy of a holistic health intervention that seeks to integrate physical, mental, spiritual, and community engagement processes into faith-based settings, compared to usual care in Bronx, NY. Briefly, the intervention involves a seven-session faith-based small group education program conducted by trained lay educators. A health ministry at each partner religious institution will be developed and sustained

Description:

The purpose of this research study is test a holistic health intervention that combines physical, mental, spiritual, and community processes into faith-based settings in Bronx, NY. The program involves a seven-session faith-based small group education sessions to be conducted by lay educators.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Intervention study participants

Inclusion Criteria:

• Age 18 and over

• Self-identify as a member of the religious institution for at least three months

• Able to read and speak in English, Vietnamese, or Khmer

Exclusion Criteria:

• Any serious health issue that may interfere with the study procedures

Key informants participants

Inclusion Criteria:

• Age 18 and over

• Must be a study implementation partner, a health ministry member, or lay educator

Exclusion Criteria:

• None

Focus group participants

Inclusion Criteria:

• Must be a participant in the intervention

• Attended at least 3 out of the 7 group education sessions as an intervention participant;

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Mental Health Issue

Intervention

Behavioral:
• The Seven Pathways to Healing, Health and Wellness curriculum
The curriculum seeks to increase civic engagement by fostering a sense of community and a sense of social and personal responsibility in community. There will be 7 monthly session that will be approximately 1 hour in duration. Session topics include: Education and Information (including mental health awareness, and a one-day certificate program in Mental Health First Aid) Connection with Others The Body as Temple Emotional Healing The Nature of Mind Life Assessment The Nature of Spirit

Locations

Country	Name	City	State
United States	NYU Langone	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in sociodemographic characteristics of participants	This will be measured by self reported participant survey about the aspects of personal and social responsibility for well-being.	baseline and 6 months visit
Secondary	Facilitators and Barriers in intervention process by Focus Group participants	A Focus group of a subset of participants will assess the facilitators and barriers in receiving the 7 sessions of the intervention. The focus groups at a private location convenient for participants. Interviews will not exceed two hours and will be audio-recorded. The focus group data will elicit facilitators and barriers to receiving the intervention and making change to improve well-being. The focus group will discuss topics such as how the group sessions impacted on the participants' physical or mental health, what was challenging or not useful and what types of tools were gained that were helpful to become more spiritually healthy.	6 months
Secondary	Facilitators and Barriers in intervention process by Key informants	The key informant interviews will contain questions that assess facilitators and barriers to implementing the intervention. The key informant interviews will be conducted once, immediately after completion of the intervention among intervention participants	6 months