Community Resilience Learning Collaborative and Research Network

Study Overview
=================
Brief Summary
-----------------
C-LEARN is designed to determine how to build service program and individual client capacity to improve mental health-related quality of life among individuals at risk for depression, with exposure to social risk factors or concerns about environmental hazards in areas of Southern Louisiana at risk for events such as hurricanes and storms. The study uses a Community Partnered Participatory Research (CPPR) framework to incorporate community priorities into study design and implementation. The first phase of C-LEARN is assessment of community priorities, assets, and opportunities for building resilience through key informant interviews and community agency outreach. Findings from this phase will inform the implementation of a two-level (program-level and individual client level) randomized study in up to six South Louisiana communities. Within communities, health and social-community service programs will be randomized to Community Engagement and Planning (CEP) for multi-sector coalition support or Technical Assistance (TA) for individual program support to implement evidence-based and community-prioritized intervention toolkits, including an expanded version of depression collaborative care and resources (referrals, manuals) to address social risk factors such as financial or housing instability and for a community resilience approach to disaster preparedness and response. Within each arm, the study will randomize individual adult clients to one of two mobile applications that provide informational resources on services for depression, social risk factors, and disaster response or also provide psychoeducation on Cognitive Behavioral Therapy to enhance coping with stress and mood. Planned data collection includes baseline, 6-month and brief monthly surveys for clients, and baseline and 12-month surveys for administrators and staff. Due to COVID-19 pandemic interruption of the study, the recruitment into the randomized controlled trials was halted. A third study part was added to assess the impact of the pandemic on participating study agencies and the community.

Detailed Description
-----------------
C-LEARN's overall aim is to determine how best to improve resilience, particularly mental health-related quality of life for individual adult clients of diverse health and community-social service programs, through alternative strategies to build capacity of programs to provide services for depression, social risk factors and disaster-related concerns, as well as through alternative forms of individual client information technology support for addressing the same range of issues. Specific aims are: To engage communities in South Louisiana in a community learning initiative on how to best build capacity to enhance resilience to depression, adverse social determinants of health, and disaster exposure. This aim includes a qualitative assessment of local community resilience priorities and assets to inform study implementation. To compare the effectiveness for improving mental health quality of life (MHRQL) (primary) and coping with stressors and other resilience outcomes (secondary), of two program-level interventions to build capacity for resilience programs: 1) Technical Assistance (TA) to individual programs vs 2) Community Engagement and Planning (CEP) to support multi-sector coalitions. To compare the effectiveness for improving MHRQL and other resilience outcomes of two mobile apps: CR and CR+eCBT: 1) CR - An app providing only information on community resources, or 2) CR+eCBT - An app providing information on community resources and education on a cognitive behavioral therapy (eCBT) based approach to enhance individual resilience (i.e., coping with mood and stressors). To describe strategies CEP coalitions used to address depression, social determinants and disaster resilience, to inform interpretation and dissemination of findings. Design The design has an overall CPPR approach to implement a 2 by 2, randomized comparative effectiveness trial. Randomization occurs at the program level to either CEP or TA, where a program is a discrete services program with its own staff and clients; there may be multiple programs within a given administrative agency, including different geographic sites such as clinics. Further, programs may offer services in different content areas, such as physical health, mental health, social services, disaster services, faith-based, etc., referred to as different sectors. In addition, individual participants will be randomized to one of two mobile apps for coping with stressors and disasters. The project and design phase has been led by a Leadership Council, including academic, community, and health system participants who have guided all aspects of the study, and operate under CPPR principles.1 Initial leaders are academic and community partners from the Community and Patient Partnered Research Network (CPPRN) across South Louisiana and Los Angeles with additional stakeholder advisors from New Orleans, Baton Rouge and Coastal South Louisiana planned for as engagement of communities proceeds.2 The Council reviews work group recommendations and facilitates larger community input and approval through a stakeholder advisory committee and larger community conferences, one of which occurred prior to publishing this phase (pre-program recruitment) of the protocol. Interventions The main comparators are CEP and TA. Healthcare and community-based programs that are assigned to CEP and TA will both receive training and support for implementation of an expanded model of evidence-based depression collaborative care that also addresses social determinants and disaster readiness. The depression toolkits to be used are from studies on adults, including, racial/ethnic minority and low-income groups, with community health worker manuals from prior work in New Orleans, adapted for community-based programs in the Community Partners In Care (CPIC) study.3-7 Toolkits use a team-based, stepped-care approach supporting assessment, referral and treatment, outcomes monitoring and care adjustment with specialty supervision and case managers for coordination and client education. While based on components of collaborative care for depression (clinical assessment and medication management for physicians; clinical assessment and CBT for licensed counselors; case management support for screening, education and patient activation, problem solving, care coordination and outreach; team management support), the interventions will also include resources to address main social determinants (e.g., poverty/financial planning, housing resources) and disaster preparedness/response, such as online resources developed after LACCDR.8 Initial adaptations have been made with stakeholder input, but work groups will continue to refine some materials prior to client recruitment. The differences between CEP and TA are described in the following sections. CEP for Coalitions CEP creates multi-sector networks to collaborate in evidence-based and community-prioritized toolkits or intervention materials.9,10 CEP supports a series of biweekly to monthly meetings to develop network and individual program capacity, prepare stakeholders as co-leads, and create a written training plan following CPPR principles.1,11 CEP councils consider local context, i.e., cultural assets and stakeholder input. Disaster preparedness and public health sectors will be encouraged to offer education/resources on social determinants and disasters within CEP training plans. CEP will be supported by a Learning Collaborative, meeting 2-3 times, using activities such as project examples, tabletop exercises and self-assessment to identify gaps and formulate goals for improvement. 8,11 TA for Individual Programs TA uses experts to train program staff via webinars and site visits, using the same toolkits as CEP, in a train the trainer approach with outside referral for intensive support such as for full supervision in CBT. TA provides a series of webinars and as needed primary care site visits, focused on team support for assessment, treatment support as appropriate with medication and/or psychotherapy, case management and educational resources and access to intervention toolkits. TA experts may include a psychiatrist, CBT expert therapist, case manager, support staff and community leader to engage service programs. The team will include experts on components such as financial planning and disaster preparedness. Individual-Level Mobile Apps C-LEARN will compare two mobile apps created as part of this study (referred to as CR and CR+eCBT) that permit interactive text messaging, mobile web, or interactive voice response (IVR) interactions, using an information technology platform (Chorus) specifically designed for participatory development.2 Each mobile app will be adapted through workgroups with stakeholders in order to tailor content to each community. The CR app will primarily provide informational resources and referral information relevant to the local community. The study team and investigators will identify resources for depression, social determinants and disaster preparedness and response within each community during planning with local stakeholders. The CR+eCBT app consists of the functionality of the CR app along with an interactive component to support CBT-informed coping with mood and stressors at the individual level. This component was developed previously by our group using participatory methods with community partners and includes interactive support to enhance social support networks, support cognitive restructuring (framed through partnered input as Catch it, Check it, Change it), and encourage pleasant activities 12. Participants will receive text message notifications (with frequency set by participants, up to several times per day) and can either reply back to messages to explore content or click a link in the message to access the interactive mobile app. Measures and outcomes (primary/secondary) are identified elsewhere in the clinicaltrials.gov submission. Randomization, sampling, and proposed statistical analysis details are available in the protocol, also included with this submission. Part three added during the pandemic consisted of qualitative interviews to assess the impact of the pandemic on organizations and communities in Southeast Louisiana. Human Subjects Protection All procedures will have prior review and approval from the LSU Health Sciences Center-New Orleans (LSUHSC-NO) Institutional Review Board (IRB), and partnering research institutions will enter into reliance agreements with LSUHSC-NO. The study currently has IRB approval to conduct qualitative interviews, and to consent and enroll participating agencies, administrators, and providers.

Official Title
-----------------
Community Resilience Learning Collaborative and Research Network

Conditions
-----------------
Depression, Social Stress, Anxiety, Quality of Life, Disaster

Intervention / Treatment
-----------------
* Other: Technical Assistance
* Other: Community Engagement and Planning
* Other: Community Resources (CR)
* Other: Community Resources + eBT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria - Providers or Administrators: 18 years of age or older English reading and writing fluency Resident of Southeast Louisiana Employed at a participating community agency Inclusion Criteria - Clients: 18 years of age or older English fluency in reading and writing Resident of Southeast Louisiana Client of a participating community agency Access to a phone that receives SMS text messages (PHQ-8 ≥ 10 OR MCS-12 ≤ 40) OR (Disaster exposure AND housing insecurity) OR (Disaster exposure AND financial insecurity) Exclusion Criteria - All: Does not meet inclusion criteria above Grossly intoxicated Mentally incapacitated

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Community agencies are randomized to participate in either of two intervention arms. Clients recruited at agencies in either community-level intervention arm are randomized at individual level to participate in one of two technology interventions. 2 arms at community level of randomization, 2 arms at individual level of randomization.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Technical Assistance<br>Technical Assistance. At the community program level of randomization, community agencies and their staff will be invited to access weekly webinars and toolkits to improve their abilities to support clients' depression care, disaster preparedness and recovery, financial security, and housing security. | Other: Technical Assistance<br>* TA for Individual Programs TA uses experts to train program staff via webinars and site visits, using the same toolkits as CEP, in a train the trainer approach. TA provides a series of webinars and as needed site visits, focused in the example of depression care on team support for assessment, treatment support as appropriate with medication and/or psychotherapy, case management and educational resources and access to intervention toolkits. It also includes webinars and training toolkits for agencies on domains of social risk factors for health (financial security and housing security) as well as disaster preparedness and recovery.<br>|
| Experimental: Community Engagement and Planning<br>Community Engagement and Planning. At the community program level of randomization, community agencies and their staff will be invited to access weekly webinars and toolkits to improve their abilities to support clients' depression care, disaster preparedness and recovery, financial security, and housing security. In addition, community agencies will be invited to meet with one another to develop novel and investigator supported coalitions using principles of community partnered participatory research that will adapt toolkits and other local assets to seek to enhance community resilience related to threats of disaster risk, financial insecurity, housing insecurity, mental health, or other coalition-determined domains. | Other: Technical Assistance<br>* TA for Individual Programs TA uses experts to train program staff via webinars and site visits, using the same toolkits as CEP, in a train the trainer approach. TA provides a series of webinars and as needed site visits, focused in the example of depression care on team support for assessment, treatment support as appropriate with medication and/or psychotherapy, case management and educational resources and access to intervention toolkits. It also includes webinars and training toolkits for agencies on domains of social risk factors for health (financial security and housing security) as well as disaster preparedness and recovery.<br>Other: Community Engagement and Planning<br>* CEP for Coalitions CEP creates multi-sector networks to collaborate in evidence-based and community-prioritized toolkits or intervention materials. CEP supports a series of biweekly to monthly meetings to develop network and individual program capacity, prepare stakeholders as co-leads, and create a written training plan following CPPR principles [48, 64]. CEP councils consider local context, i.e., cultural assets and stakeholder input. Disaster preparedness and public health sectors will be encouraged to offer education/resources on social determinants and disasters within CEP training plans. CEP will be supported by a Learning Collaborative, meeting 2-3 times, using activities such as project examples, tabletop exercises and self-assessment to identify gaps and formulate goals for improvement.<br>|
| Active Comparator: Community Resources (CR)<br>Community Resources (CR). At the Individual level of randomization, individuals in the Community Resources (CR) arm will receive access to toolkits and local resources related to depression care, disaster preparedness and recovery, financial security, and housing security. | Other: Community Resources (CR)<br>* The CR app will primarily provide informational resources and referral information relevant to the local community. We will identify resources for depression, social determinants and disaster preparedness and response within each community during planning with local stakeholders.<br>|
| Experimental: Community Resources (CR) + eBT<br>Community Resources + eBT. At the Individual level of randomization, individuals in the CR+eBT arm will receive access to toolkits and local resources related to depression care, disaster preparedness and recovery, financial security, and housing security, along with an interactive component to support CBT-informed coping with mood and stressors at the individual level. | Other: Community Resources (CR)<br>* The CR app will primarily provide informational resources and referral information relevant to the local community. We will identify resources for depression, social determinants and disaster preparedness and response within each community during planning with local stakeholders.<br>Other: Community Resources + eBT<br>* The CR+eCBT app consists of the functionality of the CR app along with an interactive component to support CBT-informed coping with mood and stressors at the individual level. This component was developed previously by our group using participatory methods with community partners and includes interactive support to enhance social support networks, support cognitive restructuring (framed through partnered input as Catch it, Check it, Change it), and encourage pleasant activities [65]. Participants will receive text message notifications (with frequency set by participants, up to several times per day) and can either reply back to messages to explore content or click a link in the message to access the interactive mobile app.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental Health Related Quality of Life | Changes in mental health-related quality of life defined by Short Form Survey (SF-12), Mental Health Composite Score (MCS). Survey scored from 0-100 using algorithm for comparison to normative data. Scores interpreted in relation to the normative mean score of 50. >50 = better mental health quality of life than the mean; <50 indicates worse physical or mental health quality of life than the mean. | Baseline and 6 months. | 
| Depression | Depression severity defined by the Personal Health Questionnaire-8 (PHQ-8). Each item is scored 0-3 (0= not at all; 3= nearly every day), yielding a possible total between 0 and 24. PHQ-8 score of 10 or greater indicates at least moderate depression. Score of 20 or more indicates likely severe or major depression. | Baseline and 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resilience | Individual resilience measured using the Brief Resilience Scale (BRS) on a 1-5 point scale. Scores below 3 indicate low resilience; scores above 4.3 indicate high resilience. | Baseline and 6 months. | 
| Physical Health Related Quality of life | Physical health-related quality of life defined by Short Form Survey (SF-12), Physical Health Composite Score (PCS). Survey scored from 0-100 using an algorithm for comparison to normative data. Scores are interpreted in relation to the normative mean score of 50. >50 = better physical health quality of life than the mean; <50 indicates worse physical or physical health quality of life than the mean. | Baseline to 6 months. | 
| Mental Wellness Indicator | Self-reported indicator of mental wellness; a response of at least sometimes in the prior 4 weeks on feeling calm or peaceful, having energy, or being happy. | Baseline and 6 months. | 
| Social Determinants of Health | Self-reported social factors that potentially affect health outcomes (mental and physical), access to care, accuracy of care, quality of care. Determined by self-report in screening survey, baseline and followup measures. | Baseline and 6 months. | 
| Behavioral Health Hospitalization | Avoiding any behavioral health hospitalization, with a sensitivity analysis of avoiding having ≥ four hospital nights. | Baseline and 6 months. | 
| Work loss days | For those employed, number of work-loss days in the prior 30 days. | Baseline and 6 months. | 
| General Anxiety Disorder (GAD-2) | General anxiety disorder is measured using the Generalized Anxiety Disorder (GAD-2). Each item is scored 0-3 yielding a possible total between 0 and 6. Scores 0-3 indicate low probability of anxiety disorder. Scores 3-6 indicate probable anxiety disorder. | Baseline and 6 months. | 
| Post Traumatic Stress Disorder | Post Traumatic Stress Disorder (PTSD) measured using Primary Care - Post Traumatic Stress Disorder Screen (PC-PTSD-5) screen for PTSD in a primary care setting. Items are scored 0 or 1 (no or yes, respectively) yielding a potential total score of 5. Score of less than 3 indicates low probability of PTSD. Score of 3 or more indicates possible PTSD. | Baseline and 6 months. | 
| Body Mass Index | Body Mass Index (BMI) measured using Weight (in pounds) and height (in feet and inches) are self-reported by participant. Weight and height will be combined to report BMI in kg/m^2. Scores are considered on a continuous scale; scores under 18.5 are classified as underweight, scores 18.5-25 are classified as normal, scores 25-30 are considered overweight; > 30 is classified as obese. | Baseline and 6 months. | 
| Cigarette Smoking- Short Term | Self-reported number of cigarettes per day in the last 7 days. | Baseline and 6 months. | 
| Cigarette Smoking- Lifetime | Self-reported smoking of 100 cigarettes or more in lifetime. Scored 1 or 0; yes or no respectively. | Baseline and 6 months. | 
| Physical Activity | Self-reported regular activity level. Scored from 1 (not active at all) to 6 (extremely active). | Baseline and 6 months. | 
| Perceived Community Resilience Capacity | Perception of community capacity for resilience adapted from Communities Advancing Resilience Toolkit (CART). Each item scored 1 to 4; 1=strongly agree 4=strongly disagree yielding total score 0 to 20. Lower score indicates more favorable perception of community resilience capacity. | Baseline and 6 months. | 
| Self-efficacy | Self-efficacy in coping with depression social risk factors and disaster threats. Self-reported confidence in ability (self-efficacy) to overcome or control depression, take effective action to treat depression, and manage side-effects of antidepressant medication(s). Scored from 1 to 4, 1= Not at all confident, 4 = extremely confident. Three items averaged; higher mean indicates greater self-efficacy. | Baseline and 6 months. | 
| Coping | Self-report of individual coping skills used and response to stressful situations using a Likert scale scored 1-5, 1= never, 5= very often. Five items averaged; higher mean indicates more frequent use of coping skills. | Baseline and 6 months. | 
| Service use | Self-reported frequency of use and care satisfaction with health and social-community, housing, financial, and disaster services. | Baseline and 6 months. | 
| Life difficulties | Self-report of life difficulties in the previous 6 months. Includes exposure to disasters, violence, child custody changes, death, employment loss. Scored 1 or 0; yes or no respectively. Five items averaged; higher mean indicates more life difficulties. | Baseline and 6 months. |