Strengthening Community Mental Health

Not Applicable

Recruiting

• Conditions: Mental Health; Anxiety; Coping; Perceived Stress; Stress; Depression; Emotional Wellbeing; Perceived Social Support

• Registration Number: NCT06093737
• Lead Sponsor: Louisiana State University and A&M College

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.

Study Timeline

• Study Start: 2023-03-25
• Status Verified: 2023-10
• Study First Submitted: 2023-10-12
• Study First Submitted QC: 2023-10-17
• Last Update Submitted: 2023-10-17
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in depression symptoms from baseline	T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)	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 community resilience from baseline	T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)	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.
Change in stress symptoms from baseline	T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)	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 stress from baseline	T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)	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 anxiety symptoms from baseline	T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)	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	T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)	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	T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)	Measured using the Coping Self-Efficacy Scale (CSES) short form, a 12-item measure of confidence in managing stressors.

Secondary Outcome Measures

Name	Time	Method
Intervention appropriateness	After delivery of 3rd session	Measured using the Appropriateness Measure (IAM), a 4 item measure of agreement with the appropriateness of the intervention.
Intervention acceptibility	After delivery of 3rd session	Measured using the Acceptability of Intervention Measure (AIM), a 4 item measure of agreement with intervention.
Intervention feasibility	After delivery of 3rd session	Measured using the Feasibility of Intervention Measure (FIM), a 4 item measure of agreement with the feasibility of implementing the intervention.

Trial Locations

Locations (1)

Together Baton Rouge; 🇺🇸 Baton Rouge, Louisiana, United States