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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 by University of California, Los Angeles
Sponsor:
Collaborators:
Louisiana State University Health Sciences Center in New Orleans
Tulane University
Healthy African American Families II
University of California, San Francisco
Arming Minorities Against Addiction & Disease
Louisiana Community Health Outreach Network
Information provided by (Responsible Party):
Bowen Chung, MD, MSHS, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT02986126
First received: December 2, 2016
Last updated: May 4, 2017
Last verified: May 2017
  Purpose

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.


Condition Intervention
Depressive Symptoms
Behavioral: Resiliency Class
Other: Resource for Services (RS)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Prevention
Official Title: Resilience Against Depression Disparities (Also Known as Resilience Education to Reduce Depression Disparities)

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Poor Mental Health-Related Quality of Life [ Time Frame: 6- and 12-month follow-up ]
    12-item mental composite score (MCS-12) ≤ 40

  • Resilience [ Time Frame: 6- and 12-month follow-up ]
    Brief Resilience Scale

  • Physical health-related quality of life [ Time Frame: 6- and 12-month follow-up ]
    12-item physical composite score (PCS-12)

  • 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)


Estimated Enrollment: 320
Actual Study Start Date: May 4, 2017
Estimated Study Completion Date: October 31, 2019
Estimated Primary Completion Date: August 30, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Active Comparator
Active Comparator: Resiliency Class +
Resiliency classes are a manualized, 7-session, cognitive behavioral therapy, psychoeducation class, lead by community health workers, that teaches skills to enhance mood. The Resiliency Class manual covers the following topics: 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 class will have up to 10 participants. Classes will be 90-120 minutes in duration and will be held weekly for seven weeks in community settings. Resiliency Classes 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 +.
Behavioral: Resiliency Class
See Arm Description
Other: Resource for Services (RS)
See Resource for Services (RS) Description
Other Name: Active Comparator

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02986126

Contacts
Contact: Krystal Griffith, MPH 310-794-2967 kgriffith@mednet.ucla.edu
Contact: Bowen Chung, MD MSHS bchung@mednet.ucla.edu

Locations
United States, California
AHF Healthcare Center - Hollywood Recruiting
Los Angeles, California, United States, 90027
Contact: Jesse Galen       Jesse.Galan@aidshealth.org   
Sponsors and Collaborators
Bowen Chung, MD, MSHS
Louisiana State University Health Sciences Center in New Orleans
Tulane University
Healthy African American Families II
University of California, San Francisco
Arming Minorities Against Addiction & Disease
Louisiana Community Health Outreach Network
Investigators
Principal Investigator: Bowen Chung, MD, MSHS University of California, Los Angeles
  More Information

Additional Information:
Publications:
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.

Responsible Party: Bowen Chung, MD, MSHS, Associate Professor-in-Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02986126     History of Changes
Other Study ID Numbers: PPRND-1507-32173
Study First Received: December 2, 2016
Last Updated: May 4, 2017
Individual Participant Data  
Plan to Share IPD: Undecided
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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, Los Angeles:
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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 24, 2017