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

Not Applicable

• Conditions: Depressive Symptoms

• Registration Number: NCT02986126
• Lead Sponsor: Bowen Chung, MD, MSHS

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 +.

Study Timeline

• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2016-12-05
• Study First Posted: 2016-12-08
• Study Start: 2017-05-04
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-14
• Primary Completion: 2019-08-01
• Study Completion: 2019-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 265

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depressive symptom count as measured by the Patient Health Questionnaire 8	Change from baseline at 6- and 12-month follow-up	The 8-item Patient Health Questionnaire (PHQ-8) is a standard measure of depressive symptoms.

Secondary Outcome Measures

Name	Time	Method
Poor Mental Health-Related Quality of Life	6- and 12-month follow-up	12-item mental composite score (MCS-12) ≤ 40
Physical health-related quality of life	6- and 12-month follow-up	12-item physical composite score (PCS-12)
Mental Wellness	6- and 12-month follow-up	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)
Resilience	6- and 12-month follow-up	Brief Resilience Scale

Trial Locations

Locations (22)

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

AMAAD; 🇺🇸 Los Angeles, 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

Metropolitan Community Church; 🇺🇸 Los Angeles, California, United States

OASIS Clinic; 🇺🇸 Los Angeles, California, United States

Southern Transmasculine Alliance; 🇺🇸 New Orleans, Louisiana, United States

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