Depression Clinical Trial
— C-LEARNOfficial title:
Community Resilience Learning Collaborative and Research Network
Verified date | May 2021 |
Source | Louisiana State University Health Sciences Center in New Orleans |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Lsuhsc-No | New Orleans | Louisiana |
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 |
United States,
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
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. |
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