- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02017262
Group Self-Management of Depression and Medical Illness
Group Self-Management for Persons With Depression and Medical Illness
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
California
-
Los Angeles, California, Forenede Stater, 90033
- LAC+USC Medical Center, Primary Care Clinics
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Self-management group
8 weekly sessions of group self-management
|
8 weekly sessions of group self-management
Andre navne:
|
|
Aktiv komparator: 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
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Depressive symptom severity (Hopkins Symptoms Checklist, or SCL)
Tidsramme: Change from baseline in depressive symptom severity at 3-months
|
Change from baseline in depressive symptom severity at 3-months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Health-related quality of life (Short-Form-12)
Tidsramme: Change from baseline in health-related quality of life at 3-months
|
Change from baseline in health-related quality of life at 3-months
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Megan Dwight-Johnson, MD MPH, VA Medical Center-West Los Angeles
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R34MH093557 (U.S. NIH-bevilling/kontrakt)
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Kliniske forsøg med Depression
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-
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-
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-
University of CincinnatiNational Center for Complementary and Integrative Health (NCCIH)RekrutteringMild depressionForenede Stater
-
Lipocine Inc.AfsluttetDepression, postpartum | Postnatal depression | Peripartum depression | Depression, post-partum | Postpartum depression (PPD) | Post-Natal depressionForenede Stater
Kliniske forsøg med Self-management group
-
University of North Carolina, Chapel HillCenters for Disease Control and PreventionAfsluttetKronisk sygdomForenede Stater
-
University of MichiganNational Institutes of Health (NIH); National Institute on Aging (NIA); Blue...Afsluttet
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University of WashingtonNational Institute of Nursing Research (NINR); East Carolina UniversityRekrutteringImplanterbar defibrillatorbruger | Stress reaktion | Ptsd | Stresshåndtering | Social kognitiv teoriForenede Stater
-
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-
Hacettepe UniversityAfsluttetHjerte-kar-sygdomme | Forhøjet blodtryk | Sundhedsadfærd | Selveffektivitet | Behandlingsoverholdelse og complianceKalkun
-
University College London HospitalsAfsluttetNeuromuskulære sygdommeDet Forenede Kongerige
-
Marmara UniversityAfsluttetMobning | MobbeofferTyrkiet (Türkiye)
-
University of Missouri-ColumbiaEunice Kennedy Shriver National Institute of Child Health and Human Development... og andre samarbejdspartnereRekrutteringSlagForenede Stater
-
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-
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