Clinical trial NCT02986126: Resilience Against Depression Disparities (Also Known as Resilience Education to Reduce Depression Disparities)
Official title: Resilience Against Depression Disparities (Also Known as Resilience Education to Reduce Depression Disparities)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Symptoms
Keywords: Depression
Resilience
Minority health
Community-based participatory research
Lesbian, gay, bisexual, transgender, and intersex (LGBTI) health
Racial / ethnic health disparities
Patient-centered outcomes research
Comparative-effectiveness research
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Louisiana State University Health Sciences Center in New Orleans
name: Tulane University
name: Healthy African American Families II
name: University of California, San Francisco
name: Arming Minorities Against Addiction & Disease
name: Louisiana Community Health Outreach Network
First posted: 2016-12-08
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Depressive symptoms and disorders are among the most common adult health conditions with a lifetime prevalence of 15-20% and are a leading cause of disability /morbidity worldwide. Although evidence-based approaches such as cognitive behavioral therapy (CBT), antidepressant medications, and depression collaborative care and quality improvement (QI) programs integrating depression care into primary health care can improve depression outcomes and disparities, racial / ethnic disparities continue to persist. Concurrently, according to a 2011 Institute of Medicine (IOM) report, little information exists on how to address the high rates of depression among sexual and gender minorities.

Our study randomizes depressed, LGBTQ (lesbian, gay, bisexual, transgendered, queer), racial / ethnic minority adults to an evidence-based agency-level, depression quality improvement (QI) training \[Resources for Services (RS)\] and technical support alone or to a resiliency class (RC+), a 7-session resiliency, cognitive behavioral therapy class to enhance mood + automated mobile text reminders about basic reminders and care follow-up impact on improving adult patients' depressive symptoms. Depression QI (RS) training will be offered to three clusters of four to five LGBTQ-focused programs: two clusters in LA (Hollywood and South LA) and one cluster in NO. Clusters are comprised of one primary care, one mental health, and two to three community agencies (e.g., faith-based, social services/support, advocacy). All programs will receive depression QI training. Enrolled adult depressed patients (n=320) will be randomized individually to RC+ or RS (depression QI) alone to assess effects on primary outcomes: depressive symptoms \[8-item patient health questionnaire (PHQ-8) score and secondary outcomes: mental health quality of life \[12-item mental composite score (MCS-12) ≤ 40\], Resilience (Brief Resilience Scale), mental wellness, and physical health quality of life \[12-item physical composite (PCS-12)score\] at 6- and 12-month follow-up.

Detailed description: Depressive symptoms and disorders are among the most common adult health conditions and are a leading cause of disability /morbidity worldwide. Although evidence-based approaches such as cognitive behavioral therapy (CBT), antidepressant medications, and depression collaborative care and quality improvement (QI) programs integrating depression care into primary health care can improve depression outcomes and disparities, racial / ethnic disparities continue to persist. Concurrently, according to a 2011 Institute of Medicine (IOM) report notes little information exists on how to address the high rates of depression among sexual and gender minorities, largely composed of lesbian, gay, and bisexual (LGBTQ) individuals. Limited comparative effectiveness data exists to know what treatments and services options improve health disparities due to patient characteristics such as race / ethnicity, and sexual orientation.

"Resilience Against Depression Disparities (RADD)" randomizes enrolled depressed, LGBTQ, racial / ethnic minority adults (n=320) to an agency-level, evidence-based depression quality improvement (QI) intervention \[Resources for Services (RS)\] training and technical support and then randomizes individuals to Resources for Services alone or to Resiliency Class+, a 7-session resiliency, depression cognitive behavioral therapy class + automated mobile text reminders about basic reminders and care follow-up impact on improving adult patients' depressive symptoms over 6- and 12-months. RS training will be offered to three clusters of four to five LGBTQ-focused programs: two clusters in LA (Hollywood and South LA) and one cluster in NO. Clusters are comprised of one primary care, one mental health, and two to three community agencies (e.g., faith-based, social services/support, advocacy). All programs will receive RS (depression QI training). All enrolled adult depressed patients will be within programs participating in RS (depression QI) trainings. Half of enrolled participants will be randomized to the Resilience Class +.

Eligibility criteria: Inclusion Criteria:

1. Age 18 or older
2. moderately to severely depressed (PHQ-8≥10)
3. Able to be contacted by phone (voice or text message), e-mail, or Facebook.
4. English or Spanish speaker

Exclusion Criteria:

1. Under age 18 years
2. Not moderately to severely depressed (PHQ-8≤10)
3. Does not currently have a phone, an email address, or a Facebook profile

Primary outcomes:
measure: Depressive symptom count as measured by the Patient Health Questionnaire 8
timeFrame: Change from baseline at 6- and 12-month follow-up
Secondary outcomes:
measure: Poor Mental Health-Related Quality of Life
timeFrame: 6- and 12-month follow-up
measure: Resilience
timeFrame: 6- and 12-month follow-up
measure: Physical health-related quality of life
timeFrame: 6- and 12-month follow-up
measure: Mental Wellness
timeFrame: 6- and 12-month follow-up
Other outcomes:
Locations:
city: Compton
country: United States
facility: R.O.A.D.S. Clinic
state: California
city: Long Beach
country: United States
facility: The ADAM Project - YMSM Program
state: California
city: Long Beach
country: United States
facility: The LGBTQ Center - Long Beach
state: California
city: Los Angeles
country: United States
facility: AMAAD
state: California
city: Los Angeles
country: United States
facility: AIDS Health Foundation Healthcare Center - Downtown Los Angeles
state: California
city: Los Angeles
country: United States
facility: AIDS Health Foundation Healthcare Center - Hollywood
state: California
city: Los Angeles
country: United States
facility: AIDS Health Foundation Public Health Division
state: California
city: Los Angeles
country: United States
facility: Metropolitan Community Church
state: California
city: Los Angeles
country: United States
facility: OASIS Clinic
state: California
city: New Orleans
country: United States
facility: Southern Transmasculine Alliance
state: Louisiana
city: New Orleans
country: United States
facility: New Orleans Musicians Clinic
state: Louisiana
city: New Orleans
country: United States
facility: St. Anna's Church
state: Louisiana
city: New Orleans
country: United States
facility: Crescent Care - The Community Awareness Network (CAN Office)
state: Louisiana
city: New Orleans
country: United States
facility: Crescent City Sanctuary
state: Louisiana
city: New Orleans
country: United States
facility: Metropolitan Community Church of New Orleans
state: Louisiana
city: New Orleans
country: United States
facility: NOAGE
state: Louisiana
city: New Orleans
country: United States
facility: Brotherhood
state: Louisiana
city: New Orleans
country: United States
facility: Crescent Care - The Movement
state: Louisiana
city: New Orleans
country: United States
facility: Crescent Care
state: Louisiana
city: New Orleans
country: United States
facility: Odyssey Home
state: Louisiana
city: New Orleans
country: United States
facility: Sisters of Perpetual Indulgence - The Big Easy Sisters
state: Louisiana
city: New Orleans
country: United States
facility: Women with a Vision
state: Louisiana
Study officials:
affiliation: University of California, Los Angeles
name: Bowen Chung, MD, MSHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moussavi S, Chatterji S, Verdes E, Tandon A, Patel V, Ustun B. Depression, chronic diseases, and decrements in health: results from the World Health Surveys. Lancet. 2007 Sep 8;370(9590):851-8. doi: 10.1016/S0140-6736(07)61415-9.
citation: Miranda J, Chung JY, Green BL, Krupnick J, Siddique J, Revicki DA, Belin T. Treating depression in predominantly low-income young minority women: a randomized controlled trial. JAMA. 2003 Jul 2;290(1):57-65. doi: 10.1001/jama.290.1.57.
citation: Wells KB, Sherbourne C, Schoenbaum M, Duan N, Meredith L, Unutzer J, Miranda J, Carney MF, Rubenstein LV. Impact of disseminating quality improvement programs for depression in managed primary care: a randomized controlled trial. JAMA. 2000 Jan 12;283(2):212-20. doi: 10.1001/jama.283.2.212.
citation: Wells KB, Tang L, Miranda J, Benjamin B, Duan N, Sherbourne CD. The effects of quality improvement for depression in primary care at nine years: results from a randomized, controlled group-level trial. Health Serv Res. 2008 Dec;43(6):1952-74. doi: 10.1111/j.1475-6773.2008.00871.x. Epub 2008 Jun 3.
citation: Gilbody S, Bower P, Fletcher J, Richards D, Sutton AJ. Collaborative care for depression: a cumulative meta-analysis and review of longer-term outcomes. Arch Intern Med. 2006 Nov 27;166(21):2314-21. doi: 10.1001/archinte.166.21.2314.
citation: Miranda J, Duan N, Sherbourne C, Schoenbaum M, Lagomasino I, Jackson-Triche M, Wells KB. Improving care for minorities: can quality improvement interventions improve care and outcomes for depressed minorities? Results of a randomized, controlled trial. Health Serv Res. 2003 Apr;38(2):613-30. doi: 10.1111/1475-6773.00136.
citation: Institute of Medicine (US) Committee on Lesbian, Gay, Bisexual, and Transgender Health Issues and Research Gaps and Opportunities. The Health of Lesbian, Gay, Bisexual, and Transgender People: Building a Foundation for Better Understanding. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK64806/
citation: Springgate BF, Wennerstrom A, Meyers D, Allen CE 3rd, Vannoy SD, Bentham W, Wells KB. Building community resilience through mental health infrastructure and training in post-Katrina New Orleans. Ethn Dis. 2011 Summer;21(3 Suppl 1):S1-20-9.
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 services to address depression disparities. J Gen Intern Med. 2013 Oct;28(10):1268-78. doi: 10.1007/s11606-013-2484-3. Epub 2013 May 7.
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 partnered, cluster, randomized, comparative effectiveness trial. Ann Intern Med. 2014 Nov 18;161(10 Suppl):S23-34. doi: 10.7326/M13-3011.
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. Psychiatr Serv. 2015 Aug 1;66(8):831-9. doi: 10.1176/appi.ps.201400099. Epub 2015 May 1.
citation: Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Ludman EJ, Young B, Peterson D, Rutter CM, McGregor M, McCulloch D. Collaborative care for patients with depression and chronic illnesses. N Engl J Med. 2010 Dec 30;363(27):2611-20. doi: 10.1056/NEJMoa1003955.
citation: U.S. Department of Health and Human Services. Advancing LGBT Health & Well-Being: 2014 Report. 2014; http://www.hhs.gov/programs/topic-sites/lgbt/index.html.
citation: Vargas SM, Wennerstrom A, Alfaro N, Belin T, Griffith K, Haywood C, Jones F, Lunn MR, Meyers D, Miranda J, Obedin-Maliver J, Pollock M, Sherbourne CD, Springgate BF, Sugarman OK, Rey E, Williams C, Williams P, Chung B. Resilience Against Depression Disparities (RADD): a protocol for a randomised comparative effectiveness trial for depression among predominantly low-income, racial/ethnic, sexual and gender minorities. BMJ Open. 2019 Oct 22;9(10):e031099. doi: 10.1136/bmjopen-2019-031099.