Group Self-Management of Depression and Medical Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02017262
Recruitment Status : Completed
First Posted : December 20, 2013
Last Update Posted : April 4, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Isabel T. Lagomasino, MD, MSHS, University of Southern California

Brief Summary:
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 or disease Intervention/treatment Phase
Depression Chronic Disease Hispanic Americans Behavioral: Self-management group Behavioral: Enhanced usual care Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Group Self-Management for Persons With Depression and Medical Illness
Actual Study Start Date : September 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Depressive symptom severity (Hopkins Symptoms Checklist, or SCL) [ Time Frame: Change from baseline in depressive symptom severity at 3-months ]

Secondary Outcome Measures :
  1. Health-related quality of life (Short-Form-12) [ Time Frame: Change from baseline in health-related quality of life at 3-months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02017262

United States, California
LAC+USC Medical Center, Primary Care Clinics
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
National Institute of Mental Health (NIMH)
Principal Investigator: Megan Dwight-Johnson, MD MPH VA Medical Center-West Los Angeles

Responsible Party: Isabel T. Lagomasino, MD, MSHS, Principal Investigator, University of Southern California Identifier: NCT02017262     History of Changes
Other Study ID Numbers: R34MH093557 ( U.S. NIH Grant/Contract )
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017

Keywords provided by Isabel T. Lagomasino, MD, MSHS, University of Southern California:
Patient education

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