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Group Self-Management of Depression and Medical Illness

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Southern California
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Isabel T. Lagomasino, MD, MSHS, University of Southern California
ClinicalTrials.gov Identifier:
NCT02017262
First received: December 10, 2013
Last updated: December 15, 2013
Last verified: December 2013
  Purpose

This project addresses the important public health need to reduce ethnic disparities in depression care by pilot testing and refining a culturally tailored, low-cost intervention for improving both depression and general medical outcomes among Latinos in safety net primary care settings. Cuerpo Sano, Mente Sana is a newly developed, lay-led, group self-management intervention that educates and empowers patients in their own health care and has the potential for widespread implementation and sustainability in primary care because it is responsive to patient, provider, and system preferences and needs. After completing an assessment of study clinic sites, we will conduct a pilot test of Cuerpo Sano, Mente Sana with 30 low-income, Spanish-speaking primary care patients. After reviewing pilot findings, we will revise the intervention and study plan, and will conduct a second pilot trial. After reviewing findings from this second trial, we will finalize the intervention and study plan in preparation for larger studies to test Cuerpo Sano, Mente Sana versus other interventions for addressing depression among Latinos in safety net primary care.


Condition Intervention
Depression
Chronic Disease
Hispanic Americans
Behavioral: Self-management group
Behavioral: Enhanced usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Group Self-Management for Persons With Depression and Medical Illness

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Depressive symptom severity (Hopkins Symptoms Checklist, or SCL) [ Time Frame: Change from baseline in depressive symptom severity at 3-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health-related quality of life (Short-Form-12) [ Time Frame: Change from baseline in health-related quality of life at 3-months ] [ Designated as safety issue: No ]

Estimated Enrollment: 108
Study Start Date: September 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Self-management group
8 weekly sessions of group self-management
Behavioral: Self-management group
8 weekly sessions of group self-management
Other Names:
  • Self-care
  • Patient education
Active Comparator: Enhanced usual care
Usual care by primary care provider, plus educational pamphlet about depression, list of local mental health resources, and letter for provider advising him/her of depression diagnosis
Behavioral: Enhanced usual care
Usual care by primary care provider, plus educational pamphlet about depression, list of local mental health resources, and letter for provider advising him/her of depression diagnosis

Detailed Description:

Latinos suffer a greater disability burden from depression than whites due to low rates of quality depression care. Depression is common among Latinos in primary care settings and is also often chronic, recurring, and comorbid with chronic medical illness. Improving outcomes for both depression and chronic medical illness requires patients to become educated, active partners in managing their illnesses. Latinos desire education regarding general and mental health; have stigma-related concerns regarding mental health care; and prefer psychotherapy to medication. However, safety net primary care providers and clinics often prioritize improving medical outcomes and lack the resources for depression care, especially psychotherapy. There is an important public health need to develop a culturally tailored, low cost intervention that includes educational and psychotherapeutic elements, targets medical illness and depression, and destigmatizes depression care.

In response to patient, provider, and clinic preferences and resources for depression care, we developed but have not yet tested an innovative, theoretically-based group intervention, drawing upon two evidence-based interventions that improve self-efficacy: group cognitive behavioral therapy (CBT) for depression and group self-management for chronic medical illness. Professionally-led group CBT is effective for depression among ethnic minorities in primary care but is difficult to sustain. Among patients with chronic medical illness, lay-led group self-management programs educate and empower patients to engage in healthful behaviors and participate in their care. The groups improve self-efficacy, health-related behaviors, and outcomes; have been adapted for diverse conditions; and have been widely disseminated and sustained. However, standard self-management groups do not improve depression. We thus enhanced the Spanish-language Tomando Control de su Salud chronic disease self-management program by adding depression-related educational and skill-building content from group CBT.

We will pilot test and refine Cuerpo Sano, Mente Sana, our newly enhanced self-management program for depression and chronic medical illness. Following a framework for successful implementation of interventions, we will 1) evaluate intervention context and refine our intervention and implementation strategy; 2) conduct a randomized trial with 30 low-income Spanish-speaking patients with depressive disorder and chronic medical illness; 3) review pilot findings of feasibility, implementation, and potential sustainability with a multistakeholder panel and then revise our materials and procedures; 4) conduct a second trial with 30 additional patients; and 5) review additional pilot findings (including 3- and 6-month intervention effects on self-efficacy, self-care behaviors, and depression and health outcomes and interviews with clinic stakeholders) and finalize the intervention and implementation strategy. This study lays the groundwork for future comparative effectiveness studies of strategies to address depression among Latinos in safety net primary care.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Established primary care patient
  • Spanish-speaking
  • Depression (major depression, dysthymia, minor depression)
  • Chronic medical illness (diabetes, hypertension, dyslipidemia, heart disease, lung disease, cerebrovascular disease, arthritis)

Exclusion Criteria:

  • Bipolar disorder
  • Psychosis
  • Cognitive impairment
  • Active suicidal ideation
  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: NCT02017262

Contacts
Contact: David Camacho, MSW, MSG 3234424051 dcamacho@usc.edu
Contact: Isabel Lagomasino, MD, MSHS 3234424046 lagomasi@usc.edu

Locations
United States, California
LAC+USC Medical Center, Primary Care Clinics Recruiting
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Megan Dwight-Johnson, MD MPH VA Medical Center-West Los Angeles
  More Information

No publications provided

Responsible Party: Isabel T. Lagomasino, MD, MSHS, Principal Investigator, University of Southern California
ClinicalTrials.gov Identifier: NCT02017262     History of Changes
Other Study ID Numbers: R34MH093557
Study First Received: December 10, 2013
Last Updated: December 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
Self-care
Patient education

Additional relevant MeSH terms:
Chronic Disease
Depression
Depressive Disorder
Behavioral Symptoms
Disease Attributes
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014