Clinical trial NCT06093737: Strengthening Community Mental Health
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
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health
Emotional Wellbeing
Anxiety
Depression
Stress
Coping
Perceived Stress
Perceived Social Support
Keywords: mental health
community-based participatory research
emotional wellbeing
perceived stress
Lead sponsor: Louisiana State University and A&M College
Sponsor class: OTHER
Collaborators: name: National Academies of Sciences, Engineering and Medicine
name: University of Illinois at Urbana-Champaign
First posted: 2023-10-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in perceived stress from baseline
timeFrame: T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)
measure: Change in depression symptoms from baseline
timeFrame: T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)
measure: Change in anxiety symptoms from baseline
timeFrame: T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)
measure: Change in stress symptoms from baseline
timeFrame: T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)
measure: Change in perceived social support from baseline
timeFrame: T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)
measure: Change in coping from baseline
timeFrame: T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)
measure: Change in community resilience from baseline
timeFrame: T1 (pre-intervention), T2 (1 month post-intervention), T3 (2 months post-intervention), T4 (3 months post-intervention)
Secondary outcomes:
measure: Intervention acceptibility
timeFrame: After delivery of 3rd session
measure: Intervention appropriateness
timeFrame: After delivery of 3rd session
measure: Intervention feasibility
timeFrame: After delivery of 3rd session
Other outcomes:
measure: Interviews
timeFrame: From date of first intervention delivery until 3 months post-date of delivery of final intervention session
measure: Focus groups
timeFrame: From date of first intervention delivery until 3 months post-date of delivery of final intervention session
measure: Intervention fidelity
timeFrame: At each intervention session.
Locations:
city: Baton Rouge
country: United States
facility: Together Baton Rouge
state: Louisiana
Study officials:
affiliation: Louisiana State University Health Sciences Center in New Orleans
name: Jennifer L Scott, PhD, LCSW
role: PRINCIPAL_INVESTIGATOR
References: