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DepressionNCT02017262

Group Self-Management of Depression and Medical Illness

A study testing Self-management group in people with Depression and Chronic Disease, run by University of Southern California at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression, Chronic Disease, Hispanic Americans
What is being tested?
Self-management group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteUnited States
Study dates
Sep 2013to Jul 2015
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • LAC+USC Medical Center, Primary Care Clinics

    Los Angeles, California, 90033

Other trials in United States

About this study

Official title: Group Self-Management for Persons With Depression and Medical Illness

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.

Read the 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.

Being tested
Self-management group, Enhanced usual care
Keywords
Self-care, Patient education
Medical subject headings
Depression, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-management groupBehavioural

    Also called Self-care, Patient education

    8 weekly sessions of group self-management

  • Enhanced usual careBehavioural

    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

Study groups in NCT02017262
Study groupRoleWhat they receive
Self-management groupExperimental8 weekly sessions of group self-management
Receives: Behavioral: Self-management group
Enhanced usual careActive comparatorUsual 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
Receives: Behavioral: Enhanced usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depressive symptom severity (Hopkins Symptoms Checklist, or SCL)

    Measured: Change from baseline in depressive symptom severity at 3-months

Secondary outcomes (1)
  1. Health-related quality of life (Short-Form-12)

    Measured: Change from baseline in health-related quality of life at 3-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02017262
Sponsor's protocol ID
R34MH093557
Status last verified
Mar 2017
First submitted
10 Dec 2013
Last updated
4 Apr 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Self-management group in people with Depression and Chronic Disease, run by University of Southern California at 1 site 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 4 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: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 severity (Hopkins Symptoms Checklist, or SCL) (time frame: Change from baseline in depressive symptom severity at 3-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 4 Apr 2017.

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