Strengthening Community Mental Health

Depression Clinical Trial

— COPE  

Official title:

Reducing Disparities in Disaster-Related Mental Health Burden: Adaptation of a Multi-level Intervention to Build Community-based Response Capacity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06093737
• Other study ID #: IRBAM-21-139105
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2023
• Est. completion date: June 2025

Study information

• Verified date: October 2023
• Source: Louisiana State University and A&M College
• Contact: Jennifer L Scott, PhD, LCSW
• Phone: 225-578-0433
• Email: jenscott[@]lsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• COPE: Communities Organizing for Power through Empathy
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.

Locations

Country	Name	City	State
United States	Together Baton Rouge	Baton Rouge	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Louisiana State University and A&M College	National Academies of Sciences, Engineering and Medicine, University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Interviews	Semi-structured interviews about experience with participating in or facilitating the intervention	From date of first intervention delivery until 3 months post-date of delivery of final intervention session
Other	Focus groups	Periodic reflections conducted with community facilitators.	From date of first intervention delivery until 3 months post-date of delivery of final intervention session
Other	Intervention fidelity	Assessed via facilitator observation using a structured fidelity questionnaire/form.	At each intervention session.
Primary	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.	T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)
Primary	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.	T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)
Primary	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.	T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)
Primary	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.	T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)
Primary	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.	T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)
Primary	Change in coping from baseline	Measured using the Coping Self-Efficacy Scale (CSES) short form, a 12-item measure of confidence in managing stressors.	T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)
Primary	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.	T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)
Secondary	Intervention acceptibility	Measured using the Acceptability of Intervention Measure (AIM), a 4 item measure of agreement with intervention.	After delivery of 3rd session
Secondary	Intervention appropriateness	Measured using the Appropriateness Measure (IAM), a 4 item measure of agreement with the appropriateness of the intervention.	After delivery of 3rd session
Secondary	Intervention feasibility	Measured using the Feasibility of Intervention Measure (FIM), a 4 item measure of agreement with the feasibility of implementing the intervention.	After delivery of 3rd session