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Strengthening Community Mental Health (COPE)

Primary Purpose

Mental Health, Emotional Wellbeing, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COPE: Communities Organizing for Power through Empathy
Sponsored by
Louisiana State University and A&M College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mental Health focused on measuring mental health, community-based participatory research, emotional wellbeing, perceived stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Individuals 18 years of age or older who are staff or members of an organization that is part of Together Baton Rouge and who participate in the intervention or are/were involved in the adaptation or implementation of the brief intervention in any capacity Exclusion Criteria: Persons who are not 18 years of age or older and persons who are not staff or members of an organization that is part of Together Baton Rouge and/or not involved with the intervention

Sites / Locations

  • Together Baton RougeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

COPE Intervention

House Meeting Control

Arm Description

Is a three session brief group psychoeducational intervention. Session 1 is 4 hours, Session 2 and 3 are 1.5 hours. It is delivered in groups of 8-15 people with sessions spaced 1 month apart.

Is a 1.5 hour group meeting delivered in groups of 8-15 people spaced 1 month apart.

Outcomes

Primary Outcome Measures

Change in perceived stress from baseline
Measured using Perceived Stress Scale, a 10-item scale that measures the degree to which a person appraises situations in their life as stressful.
Change in depression symptoms from baseline
Measured using The Depression, Anxiety, and Stress Scale (DASS), a set of three self-report scales designed to measure depression, anxiety and stress.
Change in anxiety symptoms from baseline
Measured using The Depression, Anxiety, and Stress Scale (DASS), a set of three self-report scales designed to measure depression, anxiety and stress.
Change in stress symptoms from baseline
Measured using The Depression, Anxiety, and Stress Scale (DASS), a set of three self-report scales designed to measure depression, anxiety and stress.
Change in perceived social support from baseline
Measured using the Multidimensional Scale of Perceived Social Support (MSPSS) is a 12 item scale, assessing perceived social support and connection.
Change in coping from baseline
Measured using the Coping Self-Efficacy Scale (CSES) short form, a 12-item measure of confidence in managing stressors.
Change in community resilience from baseline
Measured using the Communities Advancing Resilience Toolkit (CART), a 21-item measure of community resilience items across 4 interrelated domains that both reflect and contribute to community resilience: (1) Connection and Caring; (2) Resources; (3) Transformative Potential; and (4) Disaster Management.

Secondary Outcome Measures

Intervention acceptibility
Measured using the Acceptability of Intervention Measure (AIM), a 4 item measure of agreement with intervention.
Intervention appropriateness
Measured using the Appropriateness Measure (IAM), a 4 item measure of agreement with the appropriateness of the intervention.
Intervention feasibility
Measured using the Feasibility of Intervention Measure (FIM), a 4 item measure of agreement with the feasibility of implementing the intervention.

Full Information

First Posted
October 12, 2023
Last Updated
October 17, 2023
Sponsor
Louisiana State University and A&M College
Collaborators
National Academies of Sciences, Engineering and Medicine, University of Illinois at Urbana-Champaign
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1. Study Identification

Unique Protocol Identification Number
NCT06093737
Brief Title
Strengthening Community Mental Health
Acronym
COPE
Official Title
Reducing Disparities in Disaster-Related Mental Health Burden: Adaptation of a Multi-level Intervention to Build Community-based Response Capacity
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Louisiana State University and A&M College
Collaborators
National Academies of Sciences, Engineering and Medicine, University of Illinois at Urbana-Champaign

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to examine the impact of the Communities Organizing for Power through Empathy (COPE) intervention in adults in communities having recently experienced or at risk of experiencing disaster. The main questions it aims to answer are: How does the COPE intervention affect individual mental health? How does the COPE intervention affect protective factors like coping and social support? How does the COPE intervention affect community resilience? How does delivery of the COPE intervention in partnership with a broad-based organization affect participant recruitment and retention, as well as outcomes? Participants will participate in the three session COPE intervention. Researchers will compare individuals who participate in the COPE intervention to individuals who participate in house meetings to see if the COPE intervention improves mental health, coping, social support and community resilience. Researchers will also examine factors that affect implementation and intervention delivery.
Detailed Description
This Community-Based Participatory Research (CBPR) study will follow a multiphase mixed-methods design to adapt, deliver, and assess the efficacy of the Communities Organizing for Power through Empathy (COPE) intervention model. We will partner with a broad-based community organization, Together Baton Rouge, to adapt the intervention model to fit the context of East Baton Rouge Parish (EBRP) and deliver it to members of religious and non-profit institutions. The objectives of the multi-level COPE intervention model are twofold: (1) reduce psychological distress and amplify protective factors among individuals and communities at risk of experiencing disasters; and (2) build individual and community psychological support response capacity. The intervention will be delivered by trained Community Facilitators (CFs) at community institutions (i.e., churches) to their institutional members. We will conduct a stepped wedge cluster randomized controlled trial (SWCRCT) to examine the impact of the COPE intervention. Measures of mental health, coping, social support and community resilience will be assessed at four timepoints (see timeline for data collection timepoints). We will conduct interviews and group reflections with CFs and participants to gain insight into their experiences with the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health, Emotional Wellbeing, Anxiety, Depression, Stress, Coping, Perceived Stress, Perceived Social Support
Keywords
mental health, community-based participatory research, emotional wellbeing, perceived stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COPE Intervention
Arm Type
Experimental
Arm Description
Is a three session brief group psychoeducational intervention. Session 1 is 4 hours, Session 2 and 3 are 1.5 hours. It is delivered in groups of 8-15 people with sessions spaced 1 month apart.
Arm Title
House Meeting Control
Arm Type
Active Comparator
Arm Description
Is a 1.5 hour group meeting delivered in groups of 8-15 people spaced 1 month apart.
Intervention Type
Behavioral
Intervention Name(s)
COPE: Communities Organizing for Power through Empathy
Intervention Description
A three session brief group psychoeducational intervention. Session 1 is 4 hours, Session 2 and 3 are 1.5 hours. It is delivered in groups of 8-15 people with sessions spaced 1 month apart.
Primary Outcome Measure Information:
Title
Change in perceived stress from baseline
Description
Measured using Perceived Stress Scale, a 10-item scale that measures the degree to which a person appraises situations in their life as stressful.
Time Frame
T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)
Title
Change in depression symptoms from baseline
Description
Measured using The Depression, Anxiety, and Stress Scale (DASS), a set of three self-report scales designed to measure depression, anxiety and stress.
Time Frame
T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)
Title
Change in anxiety symptoms from baseline
Description
Measured using The Depression, Anxiety, and Stress Scale (DASS), a set of three self-report scales designed to measure depression, anxiety and stress.
Time Frame
T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)
Title
Change in stress symptoms from baseline
Description
Measured using The Depression, Anxiety, and Stress Scale (DASS), a set of three self-report scales designed to measure depression, anxiety and stress.
Time Frame
T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)
Title
Change in perceived social support from baseline
Description
Measured using the Multidimensional Scale of Perceived Social Support (MSPSS) is a 12 item scale, assessing perceived social support and connection.
Time Frame
T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)
Title
Change in coping from baseline
Description
Measured using the Coping Self-Efficacy Scale (CSES) short form, a 12-item measure of confidence in managing stressors.
Time Frame
T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)
Title
Change in community resilience from baseline
Description
Measured using the Communities Advancing Resilience Toolkit (CART), a 21-item measure of community resilience items across 4 interrelated domains that both reflect and contribute to community resilience: (1) Connection and Caring; (2) Resources; (3) Transformative Potential; and (4) Disaster Management.
Time Frame
T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)
Secondary Outcome Measure Information:
Title
Intervention acceptibility
Description
Measured using the Acceptability of Intervention Measure (AIM), a 4 item measure of agreement with intervention.
Time Frame
After delivery of 3rd session
Title
Intervention appropriateness
Description
Measured using the Appropriateness Measure (IAM), a 4 item measure of agreement with the appropriateness of the intervention.
Time Frame
After delivery of 3rd session
Title
Intervention feasibility
Description
Measured using the Feasibility of Intervention Measure (FIM), a 4 item measure of agreement with the feasibility of implementing the intervention.
Time Frame
After delivery of 3rd session
Other Pre-specified Outcome Measures:
Title
Interviews
Description
Semi-structured interviews about experience with participating in or facilitating the intervention
Time Frame
From date of first intervention delivery until 3 months post-date of delivery of final intervention session
Title
Focus groups
Description
Periodic reflections conducted with community facilitators.
Time Frame
From date of first intervention delivery until 3 months post-date of delivery of final intervention session
Title
Intervention fidelity
Description
Assessed via facilitator observation using a structured fidelity questionnaire/form.
Time Frame
At each intervention session.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals 18 years of age or older who are staff or members of an organization that is part of Together Baton Rouge and who participate in the intervention or are/were involved in the adaptation or implementation of the brief intervention in any capacity Exclusion Criteria: Persons who are not 18 years of age or older and persons who are not staff or members of an organization that is part of Together Baton Rouge and/or not involved with the intervention
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer L Scott, PhD, LCSW
Phone
225-578-0433
Email
jenscott@lsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tara L Powell, PhD
Phone
217-300-0917
Email
tlpowell@illinois.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer L Scott, PhD, LCSW
Organizational Affiliation
Louisiana State University Health Sciences Center in New Orleans
Official's Role
Principal Investigator
Facility Information:
Facility Name
Together Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70802
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khalid Hudson
Email
khudson.tbr@gmail.com
First Name & Middle Initial & Last Name & Degree
Tara Powell, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Strengthening Community Mental Health

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