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Group Self-Management of Depression and Medical Illness

Primary Purpose

Depression, Chronic Disease, Hispanic Americans

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-management group
Enhanced usual care
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Self-care, Patient education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LAC+USC Medical Center, Primary Care Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-management group

Enhanced usual care

Arm Description

8 weekly sessions of group self-management

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

Outcomes

Primary Outcome Measures

Depressive symptom severity (Hopkins Symptoms Checklist, or SCL)

Secondary Outcome Measures

Health-related quality of life (Short-Form-12)

Full Information

First Posted
December 10, 2013
Last Updated
March 31, 2017
Sponsor
University of Southern California
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02017262
Brief Title
Group Self-Management of Depression and Medical Illness
Official Title
Group Self-Management for Persons With Depression and Medical Illness
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Chronic Disease, Hispanic Americans
Keywords
Self-care, Patient education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-management group
Arm Type
Experimental
Arm Description
8 weekly sessions of group self-management
Arm Title
Enhanced usual care
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Self-management group
Other Intervention Name(s)
Self-care, Patient education
Intervention Description
8 weekly sessions of group self-management
Intervention Type
Behavioral
Intervention Name(s)
Enhanced usual care
Intervention Description
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 Measure Information:
Title
Depressive symptom severity (Hopkins Symptoms Checklist, or SCL)
Time Frame
Change from baseline in depressive symptom severity at 3-months
Secondary Outcome Measure Information:
Title
Health-related quality of life (Short-Form-12)
Time Frame
Change from baseline in health-related quality of life at 3-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan Dwight-Johnson, MD MPH
Organizational Affiliation
VA Medical Center-West Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
LAC+USC Medical Center, Primary Care Clinics
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

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Group Self-Management of Depression and Medical Illness

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