Resilience Against Depression Disparities (Also Known as Resilience Education to Reduce Depression Disparities)

Depressive Symptoms Clinical Trial

— RADD  

Official title:

Resilience Against Depression Disparities (Also Known as Resilience Education to Reduce Depression Disparities)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02986126
• Other study ID #: PPRND-1507-32173
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 4, 2017
• Est. completion date: November 1, 2019

Study information

• Verified date: August 2018
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 +.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 265
• Est. completion date: November 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Symptoms

Intervention

Behavioral:
• Resiliency Class
See Arm Description

Other:
• Resource for Services (RS)
See Resource for Services (RS) Description

Locations

Country	Name	City	State
United States	R.O.A.D.S. Clinic	Compton	California
United States	The ADAM Project - YMSM Program	Long Beach	California
United States	The LGBTQ Center - Long Beach	Long Beach	California
United States	AIDS Health Foundation Healthcare Center - Downtown Los Angeles	Los Angeles	California
United States	AIDS Health Foundation Healthcare Center - Hollywood	Los Angeles	California
United States	AIDS Health Foundation Public Health Division	Los Angeles	California
United States	AMAAD	Los Angeles	California
United States	Metropolitan Community Church	Los Angeles	California
United States	OASIS Clinic	Los Angeles	California
United States	Brotherhood	New Orleans	Louisiana
United States	Crescent Care	New Orleans	Louisiana
United States	Crescent Care - The Community Awareness Network (CAN Office)	New Orleans	Louisiana
United States	Crescent Care - The Movement	New Orleans	Louisiana
United States	Crescent City Sanctuary	New Orleans	Louisiana
United States	Metropolitan Community Church of New Orleans	New Orleans	Louisiana
United States	New Orleans Musicians Clinic	New Orleans	Louisiana
United States	NOAGE	New Orleans	Louisiana
United States	Odyssey Home	New Orleans	Louisiana
United States	Sisters of Perpetual Indulgence - The Big Easy Sisters	New Orleans	Louisiana
United States	Southern Transmasculine Alliance	New Orleans	Louisiana
United States	St. Anna's Church	New Orleans	Louisiana
United States	Women with a Vision	New Orleans	Louisiana

Sponsors (7)

Lead Sponsor	Collaborator
Bowen Chung, MD, MSHS	Arming Minorities Against Addiction & Disease, Healthy African American Families II, Louisiana Community Health Outreach Network, Louisiana State University Health Sciences Center in New Orleans, Tulane University, University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (13)

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, 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

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. Review. — View 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 — View 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 — View 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. — View 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. He — View 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. — View 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. — View 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.

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

Wells KB, Sherbourne C, Schoenbaum M, Duan N, Meredith L, Unützer 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): — View 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 — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptom count as measured by the Patient Health Questionnaire 8	The 8-item Patient Health Questionnaire (PHQ-8) is a standard measure of depressive symptoms.	Change from baseline at 6- and 12-month follow-up
Secondary	Poor Mental Health-Related Quality of Life	12-item mental composite score (MCS-12) = 40	6- and 12-month follow-up
Secondary	Resilience	Brief Resilience Scale	6- and 12-month follow-up
Secondary	Physical health-related quality of life	12-item physical composite score (PCS-12)	6- and 12-month follow-up
Secondary	Mental Wellness	3 items in last 4 weeks: some feeling of being calm or peaceful, having energy or being happy (from 36-item Short Form Health Survey)	6- and 12-month follow-up

External Links

•   Patient-Centered Outcomes Research Institute Project Summary