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

Study Overview
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Brief Summary
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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
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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 +.

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

Conditions
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Depressive Symptoms

Intervention / Treatment
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* Behavioral: Resiliency Class
* Other: Resource for Services (RS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resources for Services<br>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)<br>* See Resource for Services (RS) Description<br>* Other names: Active Comparator;|
| Active Comparator: Resiliency Class +<br>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<br>* See Arm Description<br>Other: Resource for Services (RS)<br>* See Resource for Services (RS) Description<br>* Other names: Active Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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