Community Resilience Learning Collaborative and Research Network

Depression Clinical Trial

— C-LEARN  

Official title:

Community Resilience Learning Collaborative and Research Network

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03977844
• Other study ID #: 2000008324
• Status: Completed
• Phase: N/A
• Start date: November 11, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2021
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: December 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Disaster
• Quality of Life
• Social Stress

Intervention

Other:
• Technical Assistance
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.
• Community Engagement and Planning
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.
• Community Resources (CR)
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.
• Community Resources + eBT
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.

Locations

Country	Name	City	State
United States	Lsuhsc-No	New Orleans	Louisiana

Sponsors (4)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center in New Orleans	National Academies of Sciences - Gulf Research Program, University of California, Los Angeles, University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (5)

Acosta JD, Augustine LA, Birch TL, et al. Strengthening the Response to Disasters and Trauma. In: Plough AL, ed. Community Resilience. Oxford University Press; 2021:140-153. doi:10.1093/oso/9780197559383.003.0012

Everett A, Sugarman O, Wennerstrom A, et al. Community-informed strategies to address trauma and enhance resilience in climate-affected communities. Traumatology. 2020;26(3):285-297. doi:10.1037/trm0000225

Palinkas LA, Springgate BF, Sugarman OK, Hancock J, Wennerstrom A, Haywood C, Meyers D, Johnson A, Polk M, Pesson CL, Seay JE, Stallard CN, Wells KB. A Rapid Assessment of Disaster Preparedness Needs and Resources during the COVID-19 Pandemic. Int J Envir — View Citation

Pollock MJ, Wennerstrom A, True G, Everett A, Sugarman O, Haywood C, Johnson A, Meyers D, Sato J, Wells KB, Arevian AC, Massimi M, Berry J, Riefberg L, Onyewuenyi N, Springgate B. Preparedness and Community Resilience in Disaster-Prone Areas: Cross-Sector — View Citation

Springgate BF, Arevian AC, Wennerstrom A, Johnson AJ, Eisenman DP, Sugarman OK, Haywood CG, Trapido EJ, Sherbourne CD, Everett A, McCreary M, Meyers D, Kataoka S, Tang L, Sato J, Wells KB. Community Resilience Learning Collaborative and Research Network (C-LEARN): Study Protocol with Participatory Planning for a Randomized, Comparative Effectiveness Trial. Int J Environ Res Public Health. 2018 Aug 7;15(8). pii: E1683. doi: 10.3390/ijerph15081683. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medication for a mental health disorder	Self-reported use or prescription of any antidepressant, mood stabilizer, and any antipsychotic in the previous 6 months.	Baseline and 6 months.
Other	Barriers to care	Self-report of potential barriers to pursuing or receiving care, quality of care, or delayed service provision.	Baseline and 6 months.
Other	Alcohol use	Occurrence and severity of alcohol use adapted from the Alcohol Use Disorders Identification Test (AUDIT). Self-report of number of drinks consumed on a typical day, and frequency of alcohol use within a week or month. Latter two items scored 0 to 4, 0 = never 4=daily or almost daily/4 or more times a week. Total possible score = 0 to 8. Score of 3 AND >5 drinks per day = heavy or hazardous drinking.	Baseline and 6 months.
Other	Substance use	Occurrence or severity of potential substance use and substance use disorder measured using Drug Screening Questionnaire (DAST). Scored 1 or 0; "yes" or "no" respectively; total score 0-10. 0=low risk; 1-2 = risky; 3-5 = harmful; 6-10 = severe.	Baseline and 6 months.
Other	Social Support	Individual perceived social support measure adapted from Medical Outcomes Study (MOS) Social Support Survey. Scored 1-6; 1= all of the time, 6= none of the time. Average of all scores collected. Lower average indicates higher perceived social support.	Baseline and 6 months.
Other	Chronic health conditions	Self-report of a series of chronic health conditions including but not limited to diabetes, hypertension, etc.	Baseline and 6 months.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Behavioral Health Hospitalization	Avoiding any behavioral health hospitalization, with a sensitivity analysis of avoiding having = four hospital nights.	Baseline and 6 months.
Secondary	Work loss days	For those employed, number of work-loss days in the prior 30 days.	Baseline and 6 months.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Cigarette Smoking- Short Term	Self-reported number of cigarettes per day in the last 7 days.	Baseline and 6 months.
Secondary	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.
Secondary	Physical Activity	Self-reported regular activity level. Scored from 1 (not active at all) to 6 (extremely active).	Baseline and 6 months.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Service use	Self-reported frequency of use and care satisfaction with health and social-community, housing, financial, and disaster services.	Baseline and 6 months.
Secondary	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.

External Links

•   The official webpage for the C-LEARN study. Includes intervention materials, additional academic publications, presentations, and more.