Depression Clinical Trial
— CPICOfficial title:
CPIC is a Community Partnered Participatory Research (CPPR) Project of Community and Academic Partners Working Together to Learn the Best Way to Reduce Depression in Our Communities.
Verified date | June 2021 |
Source | RAND |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
CPIC is a community initiative and research study funded by the NIH. CPIC was developed and is being run by community and academic partners in Los Angeles underserved communities of color. CPIC compares two ways of supporting diverse health and social programs in under-resourced communities to improve their services to depressed clients. One approach is time-limited expert technical assistance coupled with culturally-competent community outreach to individual programs, on how to use quality improvement toolkits for depression that have already been proven to be effective or helpful in primary care settings, but adapted for this study for use in diverse community-based programs in underserved communities. The other approach brings different types of agencies and members in a community together in a 4 to 6-month planning process, to fit the same depression quality improvement programs to the needs and strengths of the community and to develop a network of programs serving the community to support clients with depression together. The study is designed to determine the added value of community engagement and planning over and above what might be offered through a community-oriented, disease management company. Both intervention models are based on the same quality improvement toolkits that support team leadership, care management, Cognitive Behavioral Therapy, medication management, and patient education and activation. Investigators hypothesized that the community engagement approach would increase agency and clinician participation in evidence-based trainings and improve client mental health-related quality of life. In addition, during the design phase, community participants prioritized adding as outcomes indicators of social determinants of mental health, including physical functioning, risk factors for homelessness and employment. Investigators hypothesized by activating community agencies that can address health and social services needs to engage depressed clients, these outcomes would also be improved more in the collaboration condition. Investigators also hypothesized that the collaboration approach would increase use of services.
Status | Completed |
Enrollment | 1246 |
Est. completion date | May 31, 2016 |
Est. primary completion date | May 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Administrators - Age 18 and above - Work or volunteer for an enrolled program in the study and be designated as a liaison by the program Providers - Age 18 and above - Have direct contact with patients/clients Clients - Age 18 and above - Score 10 or greater on modified Patient Health Questionnaire (PHQ-8) Exclusion Criteria: grossly disorganized by screener staff assessment Not providing personal contact information Administrators - Under age 18 Providers - Under age 18 Clients - Under age 18 - Gross cognitive disorganization by screener staff assessment - Providing no contact information |
Country | Name | City | State |
---|---|---|---|
United States | Krystal M Griffith | Gardena | California |
Lead Sponsor | Collaborator |
---|---|
RAND | National Institute of Mental Health (NIMH), National Institute on Minority Health and Health Disparities (NIMHD), National Library of Medicine (NLM), Patient-Centered Outcomes Research Institute, Robert Wood Johnson Foundation |
United States,
Arevian AC, Jones F, Tang L, Sherbourne CD, Jones L, Miranda J; Community Partners in Care Writing Group. Depression Remission From Community Coalitions Versus Individual Program Support for Services: Findings From Community Partners in Care, Los Angeles, — View Citation
Barceló NE, Lopez A, Tang L, Aguilera Nunez MG, Jones F, Miranda J, Chung B, Arevian A, Bonds C, Izquierdo A, Dixon E, Wells K. Community Engagement and Planning versus Resources for Services for Implementing Depression Quality Improvement: Exploratory An — View Citation
Belin TR, Jones A, Tang L, Chung B, Stockdale SE, Jones F, Wright A, Sherbourne CD, Perlman J, Pulido E, Ong MK, Gilmore J, Miranda J, Dixon E, Jones L, Wells KB. Maintaining Internal Validity in Community Partnered Participatory Research: Experience from the Community Partners in Care Study. Ethn Dis. 2018 Sep 6;28(Suppl 2):357-364. doi: 10.18865/ed.28.S2.357. eCollection 2018. — View Citation
Castillo EG, Shaner R, Tang L, Chung B, Jones F, Whittington Y, Miranda J, Wells KB. Improving Depression Care for Adults With Serious Mental Illness in Underresourced Areas: Community Coalitions Versus Technical Support. Psychiatr Serv. 2018 Feb 1;69(2): — View Citation
Chang ET, Wells KB, Gilmore J, Tang L, Morgan AU, Sanders S, Chung B. Comorbid depression and substance abuse among safety-net clients in Los Angeles: a community participatory study. Psychiatr Serv. 2015 Mar 1;66(3):285-94. doi: 10.1176/appi.ps.201300318 — View Citation
Choi KR, Sherbourne C, Tang L, Castillo E, Dixon E, Jones A, Chung B, Eisen C, Wells K. A Comparative Effectiveness Trial of Depression Collaborative Care: Subanalysis of Comorbid Anxiety. West J Nurs Res. 2019 Jul;41(7):1009-1031. doi: 10.1177/0193945918 — View Citation
Chung B, Jones L, Dixon EL, Miranda J, Wells K; Community Partners in Care Steering Council. Using a community partnered participatory research approach to implement a randomized controlled trial: planning community partners in care. J Health Care Poor Underserved. 2010 Aug;21(3):780-95. doi: 10.1353/hpu.0.0345. — View Citation
Chung B, Ngo VK, Ong MK, Pulido E, Jones F, Gilmore J, Stoker-Mtume N, Johnson M, Tang L, Wells KB, Sherbourne C, Miranda J. Participation in Training for Depression Care Quality Improvement: A Randomized Trial of Community Engagement or Technical Support — View Citation
Chung B, Ong M, Ettner SL, Jones F, Gilmore J, McCreary M, Ngo VK, Sherbourne C, Tang L, Dixon E, Koegel P, Miranda J, Wells KB. 12-Month Cost Outcomes of Community Engagement Versus Technical Assistance for Depression Quality Improvement: A Partnered, Cl — View Citation
Chung B, Ong M, Ettner SL, Jones F, Gilmore J, McCreary M, Sherbourne C, Ngo V, Koegel P, Tang L, Dixon E, Miranda J, Belin TR, Wells KB. 12-month outcomes of community engagement versus technical assistance to implement depression collaborative care: a p — View Citation
Dixon EL, Flaskerud JH. Community tailored responses to depression care. Issues Ment Health Nurs. 2010 Sep;31(9):611-3. doi: 10.3109/01612841003675303. — View Citation
Goodsmith N, Zhang L, Ong M, Ngo VK, Miranda J, Hirsch S, Jones F, Wells K, Chung B. Addressing Suicidality in Research Protocols for Under-Resourced Communities: A Case Study from Community Partners in Care. Psychiatric Services Research (in press)
Khodyakov D, Mendel P, Dixon E, Jones A, Masongsong Z, Wells K. Community Partners in Care: Leveraging Community Diversity to Improve Depression Care for Underserved Populations. Int J Divers Organ Communities Nations. 2009;9(2):167-182. — View Citation
Khodyakov D, Pulido E, Ramos A, Dixon E. Community-partnered research conference model: the experience of Community Partners in Care study. Prog Community Health Partnersh. 2014 Spring;8(1):83-97. doi: 10.1353/cpr.2014.0008. — View Citation
Landry CM, Jackson AP, Tang L, Miranda J, Chung B, Jones F, Ong MK, Wells K. The Effects of Collaborative Care Training on Case Managers' Perceived Depression-Related Services Delivery. Psychiatr Serv. 2017 Feb 1;68(2):123-130. doi: 10.1176/appi.ps.201500 — View Citation
Mango J, Cabiling E, Jones L, Lucas-Wright A, Williams P, Wells K, Pulido E, Meldrum M, Ramos A, Chung B. Community Partners in Care (CPIC): Video Summary of Rationale, Study Approach / Implementation, and Client 6-month Outcomes. CES4healthinfo. 2014 Feb 25;2014. pii: 87LWR5H2. — View Citation
Mehta P, Brown A, Chung B, Jones F, Tang L, Gilmore J, Miranda J, Wells K. Community Partners in Care: 6-Month Outcomes of Two Quality Improvement Depression Care Interventions in Male Participants. Ethn Dis. 2017 Jul 20;27(3):223-232. doi: 10.18865/ed.27 — View Citation
Mendel P, Ngo VK, Dixon E, Stockdale S, Jones F, Chung B, Jones A, Masongsong Z, Khodyakov D. Partnered evaluation of a community engagement intervention: use of a kickoff conference in a randomized trial for depression care improvement in underserved communities. Ethn Dis. 2011 Summer;21(3 Suppl 1):S1-78-88. — View Citation
Mendel P, O'Hora J, Zhang L, Stockdale S, Dixon EL, Gilmore J, Jones F, Jones A, Williams P, Sharif MZ, Masongsong Z, Kadkhoda F, Pulido E, Chung B, Wells KB. Engaging Community Networks to Improve Depression Services: A Cluster-Randomized Trial of a Community Engagement and Planning Intervention. Community Ment Health J. 2021 Apr;57(3):457-469. doi: 10.1007/s10597-020-00632-5. Epub 2020 May 19. — View Citation
Miranda J, Ong MK, Jones L, Chung B, Dixon EL, Tang L, Gilmore J, Sherbourne C, Ngo VK, Stockdale S, Ramos E, Belin TR, Wells KB. Community-partnered evaluation of depression services for clients of community-based agencies in under-resourced communities — View Citation
Morton I, Hurley B, Castillo EG, Tang L, Gilmore J, Jones F, Watkins K, Chung B, Wells K. Outcomes of two quality improvement implementation interventions for depression services in adults with substance use problems. Am J Drug Alcohol Abuse. 2020;46(2):2 — View Citation
Ngo VK, Sherbourne C, Chung B, Tang L, Wright AL, Whittington Y, Wells K, Miranda J. Community Engagement Compared With Technical Assistance to Disseminate Depression Care Among Low-Income, Minority Women: A Randomized Controlled Effectiveness Study. Am J — View Citation
Ong MK, Jones L, Aoki W, Belin TR, Bromley E, Chung B, Dixon E, Johnson MD, Jones F, Koegel P, Khodyakov D, Landry CM, Lizaola E, Mtume N, Ngo VK, Perlman J, Pulido E, Sauer V, Sherbourne CD, Tang L, Vidaurri E, Whittington Y, Williams P, Lucas-Wright A, — View Citation
Sherbourne CD, Aoki W, Belin TR, Bromley E, Chung B, Dixon E, Gilmore JM, Johnson MD, Jones F, Koegel P, Khodyakov D, Landry CM, Lizaola E, Mtume N, Ngo VK, Ong MK, Perlman J, Pulido E, Sauer V, Tang L, Whittington Y, Vidaurri E, Williams P, Lucas-Wright — View Citation
Springgate B, Tang L, Ong M, Aoki W, Chung B, Dixon E, Johnson MD, Jones F, Landry C, Lizaola E, Mtume N, Ngo VK, Pulido E, Sherbourne C, Wright AL, Whittington Y, Williams P, Zhang L, Miranda J, Belin T, Gilmore J, Jones L, Wells KB. Comparative Effectiv — View Citation
Wells KB, Jones L, Chung B, Dixon EL, Tang L, Gilmore J, Sherbourne C, Ngo VK, Ong MK, Stockdale S, Ramos E, Belin TR, Miranda J. Community-partnered cluster-randomized comparative effectiveness trial of community engagement and planning or resources for — View Citation
* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent of Participants With Poor Mental Health Quality of Life, MCS12= 40 | From the Short Form, 12-item quality of life measure, mental health-related quality of life is the primary client outcome. Poor mental health related quality of life is defined as MCS12= 40 (one standard deviation below population mean). | 6 months follow-up | |
Primary | Percent of Participants With PHQ-9 Score = 10 | Patient Health Questionnaire 9-item version (PHQ-9) at least mild depression (score = 10) | 6 months follow-up | |
Primary | Percent of Participants With Poor Mental Health Quality of Life, MCS12= 40 | From the Short Form, 12-item quality of life measure, mental health-related quality of life is the primary client outcome. Poor mental health related quality of life is defined as MCS12= 40 (one standard deviation below population mean). | 12 months follow-up | |
Primary | Percent of Participants With Poor Mental Health Quality of Life, MCS12= 40 | From the Short Form, 12-item quality of life measure, mental health-related quality of life is the primary client outcome. Poor mental health related quality of life is defined as MCS12= 40 (one standard deviation below population mean). | 36 months follow-up | |
Primary | Percent of Participants With PHQ-8 Score = 10 | Patient Health Questionnaire 8-item version (PHQ-8) at least mild depression (score = 10) | 36 months follow-up | |
Secondary | Percent of Participants With Mental Wellness | Mental wellness is defined as at least a good bit of time in the prior 4 weeks on any of three items: feeling peaceful or calm, being a happy person, having energy | 6 months follow-up | |
Secondary | Percent of Participants Reported Organized Life | A response of somewhat or definitely true to "my life is organized" versus unsure or somewhat false or definitely false | 6 months follow-up | |
Secondary | Percent of Participants With Physically Active | Physically Active is defined as at least active to "How physically active you are?" | 6 months follow-up | |
Secondary | Percent of Participants With Homeless or = 2 Risk Factors for Homelessness | Defined as current homelessness or living in a shelter or having at least 2 risk factors (e.g., no place to stay for at least 2 nights or eviction from a primary residence, financial crisis, or food insecurity in the past 6 months) | 6 months follow-up | |
Secondary | Percent of Participants With Working for Pay | 6 months follow-up | ||
Secondary | Percent of Participants With Any Missed Work Day in Last 30 Days, if Working | 6 months follow-up | ||
Secondary | Percent of Participants With Hospitalization for Behavioral Health in the Past 6 Months | self-reported services use in the past 6 months for overnight hospital stays for mental health or substance abuse | 6 months follow-up | |
Secondary | Percent of Participants With >=4 Hospital Nights for Behavioral Health in the Past 6 Months | self-reported services use in the past 6 months with >=4 overnight hospital stays for any emotional, mental, alcohol, or drug problem, median cut point for baseline variable | 6 months follow-up | |
Secondary | Percent of Participants With >=2 Emergency Room Visits in the Past 6 Months | self-reported services use in the past 6 months with >=2 emergency room visits in past 6 months, median cut point for baseline variable | 6 months follow-up | |
Secondary | Percent of Participants With Any MHS Outpatient Visit in the Past 6 Months | self-reported mental health outpatient visit from mental health provider, including psychiatrists, psychologists, social workers, psychiatric nurses, or counselors in the past 6 months | 6 months follow-up | |
Secondary | Percent of Participants With Any PCP Visit With Depression Service in the Past 6 Months | self-reported services use in the past 6 months with any primary care visit for depression | 6 months follow-up | |
Secondary | Percent of Participants With >= 2 PCP Visits With Depression Services, if Any | 6 months follow-up | ||
Secondary | Percent of Participants With Faith-based Program Participation in the Past 6 Months | Went to any religious or spiritual places such as a church, mosque, temple, or synagogue in the past 6 months | 6 months follow-up | |
Secondary | Percent of Participants With Any Use of Park and Recreation or Community Centers in the Past 6 Months | 6 months follow-up | ||
Secondary | Percent of Participants With Use of an Antidepressant Medication for 2 Months or More in the Past 6 Months | 6 months follow-up | ||
Secondary | Medication Visits Among MHS Users in the Past 6 Months | 6 months follow-up | ||
Secondary | Faith-based Visits With Depression Service if Faith Participation in the Past 6 Months | For this sector, depression/mental health service is defined by client report of having assessment, counseling, education, medication discussion or referral for depression or emotional or mental health problems. | 6 months follow-up | |
Secondary | Park or Community Center Visits With Depression Service if Went to Park or Community Center in Past 6 Months | For this sector, depression/mental health service is defined by client report of having assessment, counseling, education, medication discussion or referral for depression or emotional or mental health problems. | 6 months follow-up | |
Secondary | Total Mental Health Related Outpatient Visits in the Past 6 Months | Total outpatient visits for depression, mental health or substance abuse from emergency rooms, primary care or public health, mental health, substance abuse, or social-community services sectors in the past 6 months | 6 months follow-up | |
Secondary | Percent of Participants With Hospitalization for Behavioral Health in the Past 6 Months | self-reported services use in the past 6 months for overnight hospital stays for mental health or substance abuse | 12 months follow-up | |
Secondary | Percent of Participants With Any MHS Outpatient Visit in the Past 6 Months | self-reported mental health outpatient visit from mental health provider, including psychiatrists, psychologists, social workers, psychiatric nurses, or counselors in the past 6 months | 12 months follow-up | |
Secondary | Percent of Participants With Any PCP Visit With Depression Service in the Past 6 Months | self-reported services use in the past 6 months with any primary care visit for depression | 12 months follow-up | |
Secondary | Percent of Participants With Faith-based Program Participation in the Past 6 Months | Went to any religious or spiritual places such as a church, mosque, temple, or synagogue in the past 6 months | 12 months follow-up | |
Secondary | Percent of Participants With Any Use of Park and Recreation or Community Centers in the Past 6 Months | 12 months follow-up | ||
Secondary | Percent of Participants With Use of an Antidepressant Medication for 2 Months or More in the Past 6 Months | 12 months follow-up | ||
Secondary | Total Mental Health Related Outpatient Visits in the Past 6 Months | Total outpatient visits for depression, mental health or substance abuse from emergency rooms, primary care or public health, mental health, substance abuse, or social-community services sectors in the past 6 months | 12 months follow-up | |
Secondary | PCS-12 Scores on 12-Item Physical Health Summary Measure, Comparison Between CEP and RS Groups | 12-item physical composite score (PCS-12). Possible scores on range from 0 to 100, with higher scores indicating better physical health | 36 months follow-up | |
Secondary | Nights Hospitalized for Behavioral Health Reason in the Past 6 Months | self-reported number of overnight hospital stays for any emotional, mental, alcohol, or drug problem in past 6 months | 36 months follow-up | |
Secondary | N of Emergency Room or Urgent Care Visits in the Past 6 Months | 36 months follow-up | ||
Secondary | N of Visits to Primary Care in Past 6 Months | 36 months follow-up | ||
Secondary | N of Outpatient Visits to Primary Care for Depression Services in the Past 6 Months | 36 months follow-up | ||
Secondary | N of Outpatient Mental Health Visits in Past 6 Months | 36 months follow-up | ||
Secondary | N of Outpatient Visits to a Substance Abuse Treatment Agency or Self Help Group in the Past 6 Months | 36 months follow-up | ||
Secondary | N of Social Services for Depression Visits in the Past 6 Months | 36 months follow-up | ||
Secondary | Number of Calls to Hotline for Substance Use or Mental Health Problem in the Past 6 Months | 36 months follow-up | ||
Secondary | N of Days on Which a Self-help Visit for Mental Health Was Made in the Past 6 Months | 36 months follow-up | ||
Secondary | Percent of Participants With Any Faith-based Services for Depression in the Past 6 Months | 36 months follow-up | ||
Secondary | Percent of Participants With Use of Any Antidepressant in the Past 6 Months | 36 months follow-up | ||
Secondary | Percent of Participants With Use of Any Mood Stabilizer in the Past 6 Months | 36 months follow-up | ||
Secondary | Percent of Participants With Use of Any Antipsychotic in the Past 6 Months | 36 months follow-up | ||
Secondary | Percent of Participants With Any Visit in Health Care Sector in the Past 6 Months | 36 months follow-up | ||
Secondary | Percent of Participants With Any Community-sector Visit for Depression in the Past 6 Months | 36 months follow-up | ||
Secondary | Percent of Participants With Any Depression Treatment in the Past 6 Months | Antidepressant use for at least two months or at least four outpatient visits to mental health or primary care setting for depression services | 36 months follow-up | |
Secondary | Survival Analysis for Time to the First Clinical Remission | clinical remission: Patient Health Questionnaire, PHQ-8 score <10. Cox Proportional Hazard model was used to examine the impact of the intervention on speed of clinical remission over the 3 years follow-up period, defined as the first assessment with clinical remission (PHQ-8<10). | from baseline to 3 years | |
Secondary | Survival Analysis for Time to the First Community-Defined Remission | Community-Defined Remission: PHQ-8<10 or MCS-12>40 or any mental wellness. Cox Proportional Hazard model was used to examine the impact of the intervention on speed of community-defined remission over the 3 years follow-up period, defined as the first assessment with community-defined (PHQ-8<10 or MCS-12>40 or any mental wellness) | from baseline to 3 years | |
Secondary | Percent of Participants With Clinical Remission | Clinical remission defined as Patient Health Questionnaire-2 (PHQ-2) score < 3. | 4 years follow-up | |
Secondary | Percent of Participants With Community-Defined Remission | Community-Defined Remission defined as PHQ-2<3, MCS-12>40, or mental wellness | 4 years follow-up |
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