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Community Resilience Learning Collaborative and Research Network (C-LEARN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03977844
Recruitment Status : Not yet recruiting
First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Collaborators:
National Academies of Sciences - Gulf Research Program
University of California, Los Angeles
Information provided by (Responsible Party):
Benjamin Springgate, Louisiana State University Health Sciences Center in New Orleans

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.

Condition or disease Intervention/treatment Phase
Depression Social Stress Anxiety Quality of Life Disaster Other: Technical Assistance Other: Community Engagement and Planning Other: Community Resources (CR) Other: Community Resources + eBT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Health Services Research
Official Title: Community Resilience Learning Collaborative and Research Network
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
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.

Experimental: 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.
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.

Other: 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.

Active Comparator: 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.
Other: 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.

Experimental: 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.
Other: 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.

Other: 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.




Primary Outcome Measures :
  1. Mental Health Related Quality of Life [ Time Frame: 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.

  2. Depression [ Time Frame: 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.


Secondary Outcome Measures :
  1. Resilience [ Time Frame: Baseline and 6 months. ]
    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.

  2. Physical Health Related Quality of life [ Time Frame: Baseline to 6 months. ]
    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.

  3. Mental Wellness Indicator [ Time Frame: Baseline and 6 months. ]
    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.

  4. Social Determinants of Health [ Time Frame: Baseline and 6 months. ]
    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.

  5. Behavioral Health Hospitalization [ Time Frame: Baseline and 6 months. ]
    Avoiding any behavioral health hospitalization, with a sensitivity analysis of avoiding having ≥ four hospital nights.

  6. Work loss days [ Time Frame: Baseline and 6 months. ]
    For those employed, number of work-loss days in the prior 30 days.

  7. General Anxiety Disorder (GAD-2) [ Time Frame: Baseline and 6 months. ]
    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.

  8. Post Traumatic Stress Disorder [ Time Frame: Baseline and 6 months. ]
    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.

  9. Body Mass Index [ Time Frame: Baseline and 6 months. ]
    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.

  10. Cigarette Smoking- Short Term [ Time Frame: Baseline and 6 months. ]
    Self-reported number of cigarettes per day in the last 7 days.

  11. Cigarette Smoking- Lifetime [ Time Frame: Baseline and 6 months. ]
    Self-reported smoking of 100 cigarettes or more in lifetime. Scored 1 or 0; "yes" or "no" respectively.

  12. Physical Activity [ Time Frame: Baseline and 6 months. ]
    Self-reported regular activity level. Scored from 1 (not active at all) to 6 (extremely active).

  13. Perceived Community Resilience Capacity [ Time Frame: Baseline and 6 months. ]
    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.

  14. Self-efficacy [ Time Frame: Baseline and 6 months. ]
    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.

  15. Coping [ Time Frame: Baseline and 6 months. ]
    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.

  16. Service use [ Time Frame: Baseline and 6 months. ]
    Self-reported frequency of use and care satisfaction with health and social-community, housing, financial, and disaster services.

  17. Life difficulties [ Time Frame: Baseline and 6 months. ]
    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.


Other Outcome Measures:
  1. Medication for a mental health disorder [ Time Frame: Baseline and 6 months. ]
    Self-reported use or prescription of any antidepressant, mood stabilizer, and any antipsychotic in the previous 6 months.

  2. Barriers to care [ Time Frame: Baseline and 6 months. ]
    Self-report of potential barriers to pursuing or receiving care, quality of care, or delayed service provision.

  3. Alcohol use [ Time Frame: Baseline and 6 months. ]
    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.

  4. Substance use [ Time Frame: Baseline and 6 months. ]
    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.

  5. Social Support [ Time Frame: Baseline and 6 months. ]
    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.

  6. Chronic health conditions [ Time Frame: Baseline and 6 months. ]
    Self-report of a series of chronic health conditions including but not limited to diabetes, hypertension, etc.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03977844


Contacts
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Contact: Joesph Moerschbaecher, PhD 504-568-5404 jmoers@lsuhsc.edu

Locations
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United States, Louisiana
Lsuhsc-No Not yet recruiting
New Orleans, Louisiana, United States, 70112
Contact: Joesph Moerschbaecher, PhD    504-568-4804    jmoers@lsuhsc.edu   
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
National Academies of Sciences - Gulf Research Program
University of California, Los Angeles
Investigators
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Principal Investigator: Benjamin Springgate, MD LSUHSC
  Study Documents (Full-Text)

Documents provided by Benjamin Springgate, Louisiana State University Health Sciences Center in New Orleans:

Publications:
Arevian A, O'hora J, Jones F, et al. Building Community Resilience through Participatory Mobile Health Technology Development.
Little RJA. Missing-data adjustments in large surveys. J Bus Econ Stat. 1988;6(3):287-296. doi:10.1080/07350015.1988.10509663
Groves RM, Dillman DA, Eltinge JL, Little RJA. Survey Nonresponse. Hoboken, NJ: Wiley-Interscience; 2002.
Korn E, Graubard B. Analysis of Health Surveys. Hoboken, NJ: Wiley-Interscience; 1999.
Benjamini Y, Hochberg Y. Benjamini Y, Hochberg Y. Controlling the false discovery rate: a practical and powerful approach to multiple testing. J R Stat Soc Ser B. 1995;57(1):289-300. doi:10.2307/2346101
Bernard H. Research Methods in Anthropology-Qualitative and Quantitative Approaches. Thousand Oaks, CA: Sage Publications; 2002.
Emerson R., Fretz R., Shaw L. Writing Ethnographic Fieldnotes. University of Chicago Press; 2011.
Miller WL, Crabtree BF. Primary care research: a multimethod typology and qualitative road map. In: Doing Qualitative Research. Vol 3. Newbury Park: Sage Publications; 1992:3-28. doi:10.1037/0022-0167.24.6.503
Ryan GW, Bernard HR. Techniques to identify themes in qualitative data. Field methods. 2003;15(1):85-109. doi:10.1177/1525822X02239569
MacQueen KM, McLellan E, Kay K, Milstein B. Codebook development for team-based qualitative analysis. Field methods. 1998;10(2):31-36. doi:10.1177/1525822X980100020301
Maxwell JA. Qualitative Research Design: An Interactive Approach (2nd Edition). Thousand Oaks, CA: Sage Publications; 2005.
Creswell J. Qualitative Inquiry and Research Design: Choosing Among Five Approaches. Thousand Oaks, CA: Sage Publications; 2012. doi:10.1016/j.aenj.2008.02.005

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Responsible Party: Benjamin Springgate, Associate Professor, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT03977844     History of Changes
Other Study ID Numbers: 2000008324
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No