Mental Health IssueNCT04353427
Improving Physical, Mental, and Spiritual Health in Faith-Based Settings Through Creating a Healthy Culture in Bronx, NY
A study testing The Seven Pathways to Healing, Health and Wellness curriculum in people with Mental Health Issue, run by NYU Langone Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- The Seven Pathways to Healing, Health and Wellness curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2020to 1 Feb 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Age 18 and over
- Must be a study implementation partner, a health ministry member, or lay educator
- Must be a participant in the intervention
- Attended at least 3 out of the 7 group education sessions as an intervention participant;
Who cannot join
- Any serious health issue that may interfere with the study procedures
- Key informants participants
- None
- Focus group participants
- None
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed 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.
- Conditions
- Mental Health Issue
- Being tested
- The Seven Pathways to Healing, Health and Wellness curriculum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Seven Pathways to Healing, Health and Wellness curriculumBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Faith based educational group | Experimental | A seven-session faith-based small group educational program using the "The Seven Pathways to Healing, Health and Wellness" curriculum will be delivered. Receives: Behavioral: The Seven Pathways to Healing, Health and Wellness curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 6 months visit
Secondary outcomes (2)
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.
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start1 May 2020
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sahnah Lim, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353427
- Sponsor's protocol ID
- 19-01617
- Status last verified
- Mar 2021
- First submitted
- 15 Apr 2020
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Physical, Mental, and Spiritual Health in Faith-Based Settings Through Creating a Healthy Culture in Bronx, NY
- ClinicalTrials.gov ID
- NCT04353427
- Acronym / sponsor ID
- 19-01617
- Conditions
- Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 20 Apr 2020 (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.
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
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Faith based educational group | Experimental | Behavioral: The Seven Pathways to Healing, Health and Wellness curriculumA seven-session faith-based small group educational program using the "The Seven Pathways to Healing, Health and Wellness" curriculum will be delivered. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Age 18 and over
- Must be a study implementation partner, a health ministry member, or lay educator
Key exclusion criteria (5 listed)
- Any serious health issue that may interfere with the study procedures
- Key informants participants
- None
- Focus group participants
- None
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 |
|---|---|---|
| The Seven Pathways to Healing, Health and Wellness curriculumThe 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: 1. Education and Information (including mental health awareness, and a one-day certificate program in Mental Health First Aid) 2. Connection with Others 3. The Body as Temple 4. Emotional Healing 5. The Nature of Mind 6. Life Assessment 7. The Nature of Spirit | Behavioural | Faith based educational group |
Primary outcome
Changes in sociodemographic characteristics of participants
Time frame: baseline and 6 months visit
This will be measured by self reported participant survey about the aspects of personal and social responsibility for well-being.
2 secondary outcomes
Facilitators and Barriers in intervention process by Focus Group participants
Time frame: 6 months
Facilitators and Barriers in intervention process by Key informants
Time frame: 6 months
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 18 Mar 2021.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Sahnah Lim, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Seven Pathways to Healing, Health and Wellness curriculum in people with Mental Health Issue, run by NYU Langone Health 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 7 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 18 Mar 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?
Changes in sociodemographic characteristics of participants (time frame: baseline and 6 months visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2021.