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

NCT02986126 | Unknown DMC

• 1 other identifier: PPRND-1507-32173
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 22

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Poor Mental Health-Related Quality of Life

  6- and 12-month follow-up

• Resilience

  6- and 12-month follow-up

• Physical health-related quality of life

  6- and 12-month follow-up

• Mental Wellness

  6- and 12-month follow-up

Study Arms (2)

Resources for Services

ACTIVE COMPARATOR

Resources for Services (RS) is an evidence-based depression QI toolkit developed for primary care, but adapted for health- and community-based programs. Protocols support training licensed providers in clinical assessment, medication management, and CBT; all staff in team management; and non-clinical staff in addressing patient safety, screening, behavioral management skills (behavioral activation, problem solving) to enable education, coordination, and referral. RS is offered as an initial 1-day / 8-hour training with follow-up through 12 webinars, 3 each on team management, medication management, psychotherapy, and case management. Programs will be invited to have a staff lead per training component, with no limit on number of staff at trainings. Training experts include a psychiatrist, psychologist/CBT trainer, case manager, support staff, and patient / community advocate liaison. All enrolled study participants will be nested within programs participating in RS.

Other: Resource for Services (RS)

Resiliency Class +

ACTIVE COMPARATOR

Resiliency Classes (RC) are a manualized, 7-session, CBT, psychoeducation class, lead by community health workers, that teaches skills to enhance mood. The RC manual covers: Session 1 - "What Affects Your Mood and Resilience;" Session 2 - "Pleasant Activities Can Help Improve Your Mood and Make You Resilient;" Session 3 - "What Gets In The Way of Pleasant Activities: Harmful Thoughts and How to Change Them;" Session 4 - "How to Increase Your Resilience Through Support from Others;" Session 5 - "My Personal Resiliency Plan: Goal Setting;" Session 6 - "Celebrate Your Resiliency: Graduation" Each RC will be 90-120 minutes in duration; once a week in community settings with up to 10 participants. RC will be supplemented with automated mobile text reminders about basic concepts and follow-up for care. Half of enrolled participants will be randomized to the Resiliency Class +. As of July 12, 2018, we will be offering bus tokens and $5 for completion of a satisfaction survey.

Behavioral: Resiliency Class; Other: Resource for Services (RS)

Interventions

Resiliency Class BEHAVIORAL

See Arm Description

Resiliency Class +

Resource for Services (RS) OTHER

See Resource for Services (RS) Description

Also known as: Active Comparator

Resiliency Class +; Resources for Services

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (22)

R.O.A.D.S. Clinic

Compton, California, 90221, United States

Location

The ADAM Project - YMSM Program

Long Beach, California, 90806, United States

Location

The LGBTQ Center - Long Beach

Long Beach, California, 90814, United States

Location

AMAAD

Los Angeles, California, 90002, United States

Location

AIDS Health Foundation Healthcare Center - Downtown Los Angeles

Los Angeles, California, 90015, United States

Location

AIDS Health Foundation Healthcare Center - Hollywood

Los Angeles, California, 90027, United States

Location

AIDS Health Foundation Public Health Division

Los Angeles, California, 90027, United States

Location

Metropolitan Community Church

Los Angeles, California, 90027, United States

Location

OASIS Clinic

Los Angeles, California, 90059, United States

Location

Southern Transmasculine Alliance

New Orleans, Louisiana, 70006, United States

Location

New Orleans Musicians Clinic

New Orleans, Louisiana, 70115, United States

Location

St. Anna's Church

New Orleans, Louisiana, 70116, United States

Location

Crescent Care - The Community Awareness Network (CAN Office)

New Orleans, Louisiana, 70117, United States

Location

Crescent City Sanctuary

New Orleans, Louisiana, 70118, United States

Location

Metropolitan Community Church of New Orleans

New Orleans, Louisiana, 70118, United States

Location

NOAGE

New Orleans, Louisiana, 70118, United States

Location

Brotherhood

New Orleans, Louisiana, 70119, United States

Location

Crescent Care - The Movement

New Orleans, Louisiana, 70119, United States

Location

Crescent Care

New Orleans, Louisiana, 70119, United States

Location

Odyssey Home

New Orleans, Louisiana, 70119, United States

Location

Sisters of Perpetual Indulgence - The Big Easy Sisters

New Orleans, Louisiana, 70119, United States

Location

Women with a Vision

New Orleans, Louisiana, 70119, United States

Location

Related Publications (14)

• 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.

  PMID: 17826170 RESULT

• 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.

  PMID: 12837712 RESULT

• 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.

  PMID: 10634337 RESULT

• 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.

  PMID: 18522664 RESULT

• 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.

  PMID: 17130383 RESULT

• 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.

  PMID: 12785564 RESULT

• 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/

  PMID: 22013611 RESULT

• 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.

  PMID: 22352077 RESULT

• 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.

  PMID: 23649787 RESULT

• 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.

  PMID: 25402400 RESULT

• 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.

  PMID: 25930037 RESULT

• 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.

  PMID: 21190455 RESULT

• 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.

  RESULT

• 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.

  PMID: 31641001 DERIVED

Related Links

• Patient-Centered Outcomes Research Institute Project Summary

MeSH Terms

Conditions

Depression; Homosexuality, Female; Homosexuality; Bisexuality; Ovotesticular Disorders of Sex Development

Interventions

Health Resources

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sexuality; Sexual Behavior; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Bowen Chung, MD, MSHS

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor-in-Residence

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 8, 2016
• Study Start: May 4, 2017
• Primary Completion: August 1, 2019
• Study Completion: November 1, 2019
• Last Updated: August 14, 2018

Record last verified: 2018-08

Locations

US (22)