Depressive SymptomsRADDNCT02986126
Resilience Against Depression Disparities (Also Known as Resilience Education to Reduce Depression Disparities)
A study testing Resiliency Class and Resource for Services (RS) in people with Depressive Symptoms, run by Bowen Chung, MD, MSHS at 22 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Resiliency Class and Resource for Services (RS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 22 sitesUnited States
- Study dates
- 4 May 2017to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
R.O.A.D.S. Clinic
Compton, California, 90221
The ADAM Project - YMSM Program
Long Beach, California, 90806
The LGBTQ Center - Long Beach
Long Beach, California, 90814
AMAAD
Los Angeles, California, 90002
AIDS Health Foundation Healthcare Center - Downtown Los Angeles
Los Angeles, California, 90015
AIDS Health Foundation Healthcare Center - Hollywood
Los Angeles, California, 90027
AIDS Health Foundation Public Health Division
Los Angeles, California, 90027
Metropolitan Community Church
Los Angeles, California, 90027
OASIS Clinic
Los Angeles, California, 90059
Southern Transmasculine Alliance
New Orleans, Louisiana, 70006
New Orleans Musicians Clinic
New Orleans, Louisiana, 70115
St. Anna's Church
New Orleans, Louisiana, 70116
Crescent Care - The Community Awareness Network (CAN Office)
New Orleans, Louisiana, 70117
Crescent City Sanctuary
New Orleans, Louisiana, 70118
Metropolitan Community Church of New Orleans
New Orleans, Louisiana, 70118
NOAGE
New Orleans, Louisiana, 70118
Brotherhood
New Orleans, Louisiana, 70119
Crescent Care - The Movement
New Orleans, Louisiana, 70119
Crescent Care
New Orleans, Louisiana, 70119
Odyssey Home
New Orleans, Louisiana, 70119
Sisters of Perpetual Indulgence - The Big Easy Sisters
New Orleans, Louisiana, 70119
Women with a Vision
New Orleans, Louisiana, 70119
About this study
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.
Read the 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 +.
- Conditions
- Depressive Symptoms
- Being tested
- Resiliency Class, Resource for Services (RS)
- 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
- Medical subject headings
- Depression, Homosexuality, Female, Homosexuality, Bisexuality, Ovotesticular Disorders of Sex Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resiliency ClassBehavioural
See Arm Description
Resource for Services (RS)Other
Also called Active Comparator
See Resource for Services (RS) Description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Resiliency Class; Other: Resource for Services (RS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at 6- and 12-month follow-up
Secondary outcomes (4)
Poor Mental Health-Related Quality of Life
12-item mental composite score (MCS-12) ≤ 40
Measured: 6- and 12-month follow-up
Resilience
Brief Resilience Scale
Measured: 6- and 12-month follow-up
Physical health-related quality of life
12-item physical composite score (PCS-12)
Measured: 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)
Measured: 6- and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study start4 May 2017
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bowen Chung, MD, MSHS
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor-investigator, Bowen Chung, MD, MSHS, University of California, Los Angeles
- Investigators
- Bowen Chung, MD, MSHS, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986126
- Sponsor's protocol ID
- PPRND-1507-32173
- Acronym
- RADD
- Status last verified
- Aug 2018
- First submitted
- 2 Dec 2016
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 17826170Miranda 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.
PubMed 12837712Wells 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.
PubMed 10634337Wells 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.
PubMed 18522664Gilbody 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.
PubMed 17130383Miranda 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.
PubMed 12785564Institute 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/
PubMed 22013611Springgate 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.
PubMed 22352077Wells 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.
PubMed 23649787Chung 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.
PubMed 25402400Chung 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.
PubMed 25930037Katon 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.
PubMed 21190455U.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.
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.
PubMed 31641001
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience Against Depression Disparities (Also Known as Resilience Education to Reduce Depression Disparities)
- ClinicalTrials.gov ID
- NCT02986126
- Acronym / sponsor ID
- RADD / PPRND-1507-32173
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Bowen Chung, MD, MSHSUniversity, hospital or other
- 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
- Study start
- 4 May 2017 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resources for Services | Active comparator | Other: Resource for Services (RS)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. |
| Resiliency Class + | Active comparator | Behavioral: Resiliency Class, Other: Resource for Services (RS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resiliency ClassSee Arm Description | Behavioural | Resiliency Class + |
| Resource for Services (RS)Also: Active ComparatorSee Resource for Services (RS) Description | Other | Resiliency Class +, Resources for Services |
Primary outcome
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.
4 secondary outcomes
Poor Mental Health-Related Quality of Life
Time frame: 6- and 12-month follow-up
Resilience
Time frame: 6- and 12-month follow-up
Physical health-related quality of life
Time frame: 6- and 12-month follow-up
Mental Wellness
Time frame: 6- and 12-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Results publication: PubMed 17826170Moussavi 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.
- Results publication: PubMed 12837712Miranda 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.
- Results publication: PubMed 10634337Wells 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.
- Results publication: PubMed 18522664Wells 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.
- Results publication: PubMed 17130383Gilbody 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.
- Results publication: PubMed 12785564Miranda 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.
- Results publication: PubMed 22013611Institute 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/
- Results publication: PubMed 22352077Springgate 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.
- Results publication: PubMed 23649787Wells 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.
- Results publication: PubMed 25402400Chung 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.
- Results publication: PubMed 25930037Chung 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.
- Results publication: PubMed 21190455Katon 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.
- Patient-Centered Outcomes Research Institute Project SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bowen Chung, MD, MSHS principal investigator
University of California, Los Angeles
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resiliency Class and Resource for Services (RS) in people with Depressive Symptoms, run by Bowen Chung, MD, MSHS at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptom count as measured by the Patient Health Questionnaire 8 (time frame: Change from baseline at 6- and 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02986126, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.