Community Resilience Learning Collaborative and Research Network
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Depression
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Client-level participants are unaware of which arm to which the agencies from which they have been recruited have been assigned at the community agency level randomization.
Providers are unaware of which clients have been recruited into the study, as well as to which arm the clients have been assigned at the individual level randomization for the technological mobile phone intervention.
Outcomes assessors at follow-up assessments are unaware of which arm the participants have been assigned at either the community or individual level.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Does not meet inclusion criteria above
- •Grossly intoxicated
- •Mentally incapacitated
研究组 & 干预措施
Technical Assistance
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.
干预措施: Technical Assistance (Other)
Community Engagement and Planning
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.
干预措施: Technical Assistance (Other)
Community Engagement and Planning
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.
干预措施: Community Engagement and Planning (Other)
Community Resources (CR) + eBT
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.
干预措施: Community Resources (CR) (Other)
Community Resources (CR)
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.
干预措施: Community Resources (CR) (Other)
Community Resources (CR) + eBT
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.
干预措施: Community Resources + eBT (Other)
结局指标
主要结局
Depression
时间窗: Baseline and 6 months.
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.
Mental Health Related Quality of Life
时间窗: Baseline and 6 months.
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.
次要结局
- Mental Wellness Indicator(Baseline and 6 months.)
- Life difficulties(Baseline and 6 months.)
- Social Determinants of Health(Baseline and 6 months.)
- General Anxiety Disorder (GAD-2)(Baseline and 6 months.)
- Coping(Baseline and 6 months.)
- Resilience(Baseline and 6 months.)
- Post Traumatic Stress Disorder(Baseline and 6 months.)
- Cigarette Smoking- Lifetime(Baseline and 6 months.)
- Perceived Community Resilience Capacity(Baseline and 6 months.)
- Physical Health Related Quality of life(Baseline to 6 months.)
- Behavioral Health Hospitalization(Baseline and 6 months.)
- Body Mass Index(Baseline and 6 months.)
- Physical Activity(Baseline and 6 months.)
- Self-efficacy(Baseline and 6 months.)
- Service use(Baseline and 6 months.)
- Work loss days(Baseline and 6 months.)
- Cigarette Smoking- Short Term(Baseline and 6 months.)
研究者
Benjamin Springgate
Associate Professor
Louisiana State University Health Sciences Center in New Orleans