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

August 13, 2018 updated by: Bowen Chung, MD, MSHS

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

265

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Compton, California, United States, 90221
        • R.O.A.D.S. Clinic
      • Long Beach, California, United States, 90806
        • The ADAM Project - YMSM Program
      • Long Beach, California, United States, 90814
        • The LGBTQ Center - Long Beach
      • Los Angeles, California, United States, 90002
        • AMAAD
      • Los Angeles, California, United States, 90015
        • AIDS Health Foundation Healthcare Center - Downtown Los Angeles
      • Los Angeles, California, United States, 90027
        • AIDS Health Foundation Healthcare Center - Hollywood
      • Los Angeles, California, United States, 90027
        • AIDS Health Foundation Public Health Division
      • Los Angeles, California, United States, 90027
        • Metropolitan Community Church
      • Los Angeles, California, United States, 90059
        • OASIS Clinic
    • Louisiana
      • New Orleans, Louisiana, United States, 70006
        • Southern Transmasculine Alliance
      • New Orleans, Louisiana, United States, 70115
        • New Orleans Musicians Clinic
      • New Orleans, Louisiana, United States, 70116
        • St. Anna's Church
      • New Orleans, Louisiana, United States, 70117
        • Crescent Care - The Community Awareness Network (CAN Office)
      • New Orleans, Louisiana, United States, 70118
        • Crescent City Sanctuary
      • New Orleans, Louisiana, United States, 70118
        • Metropolitan Community Church of New Orleans
      • New Orleans, Louisiana, United States, 70118
        • NOAGE
      • New Orleans, Louisiana, United States, 70119
        • Brotherhood
      • New Orleans, Louisiana, United States, 70119
        • Crescent Care - The Movement
      • New Orleans, Louisiana, United States, 70119
        • Crescent Care
      • New Orleans, Louisiana, United States, 70119
        • Odyssey Home
      • New Orleans, Louisiana, United States, 70119
        • Sisters of Perpetual Indulgence - The Big Easy Sisters
      • New Orleans, Louisiana, United States, 70119
        • Women With A Vision

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Resources for Services
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)
See Resource for Services (RS) Description
Other Names:
  • Active Comparator
Active Comparator: Resiliency Class +
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.
Other: Resource for Services (RS)
See Resource for Services (RS) Description
Other Names:
  • Active Comparator
Behavioral: Resiliency Class
See Arm Description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptom count as measured by the Patient Health Questionnaire 8
Time Frame: 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.
Change from baseline at 6- and 12-month follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bowen Chung, MD, MSHS

Collaborators

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

Investigators

  • Principal Investigator: Bowen Chung, MD, MSHS, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2017

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

December 2, 2016

First Submitted That Met QC Criteria

December 5, 2016

First Posted (Estimate)

December 8, 2016

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPRND-1507-32173

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

We will work with the Patient-Centered Outcomes Research Institute (PCORI) staff as the findings emerge to determine the potential value of some or all of the dataset being made publicly available, which would require additional funding from PCORI to complete. In general PCORI works with investigators to make a complete, cleaned, de-identified final data set with detailed descriptions contained within the study protocol available to PCORI for use as a publicly available dataset after study completion.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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