- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02017262
Group Self-Management of Depression and Medical Illness
Group Self-Management for Persons With Depression and Medical Illness
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
California
-
Los Angeles, California, Vereinigte Staaten, 90033
- LAC+USC Medical Center, Primary Care Clinics
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Self-management group
8 weekly sessions of group self-management
|
8 weekly sessions of group self-management
Andere Namen:
|
|
Aktiver 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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Depressive symptom severity (Hopkins Symptoms Checklist, or SCL)
Zeitfenster: Change from baseline in depressive symptom severity at 3-months
|
Change from baseline in depressive symptom severity at 3-months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Health-related quality of life (Short-Form-12)
Zeitfenster: Change from baseline in health-related quality of life at 3-months
|
Change from baseline in health-related quality of life at 3-months
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Megan Dwight-Johnson, MD MPH, VA Medical Center-West Los Angeles
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- R34MH093557 (US NIH Stipendium/Vertrag)
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Klinische Studien zur Depression
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RekrutierungAngst | Angst Depression | Depression Angststörung | Depression - Major DepressionNorwegen
-
Baskent UniversityNoch keine Rekrutierung
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-
Centre Hospitalier Universitaire de BesanconNoch keine RekrutierungMenopausale Depression | Depression - Major DepressionFrankreich
-
National University of MalaysiaNoch keine RekrutierungWiderstandsfähigkeit | Depression - Major DepressionMalaysia
-
St. Joseph's Healthcare HamiltonSun Life Financial Movement Disorders Research and Rehabilitation CentreRekrutierungDepression - Major Depression | KindheitstraumataKanada
-
Peking UniversityFirst Hospital of China Medical University; The First Hospital of Hebei Medical... und andere MitarbeiterNoch keine RekrutierungDepression - Major DepressionChina
-
Wake Forest University Health SciencesNoch keine RekrutierungDepression - Major DepressionVereinigte Staaten
-
Hanoi Medical UniversityAbgeschlossenDepression - Major DepressionVietnam
-
University of OxfordWellcome Trust; Oxford Health Biomedical Research Centre (OH BRC) support schemeRekrutierungDepression | Reizbarkeit | Depression - Major DepressionVereinigtes Königreich
Klinische Studien zur Self-management group
-
University of CincinnatiNoch keine RekrutierungDiabetes mellitus, Typ 2 | PrädiabetesVereinigte Staaten
-
University of Southern CaliforniaAbgeschlossenDepression | Diabetes | HerzkrankheitVereinigte Staaten
-
University of MichiganNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)AbgeschlossenTyp 2 Diabetes mellitusVereinigte Staaten
-
US Department of Veterans AffairsAbgeschlossenChronischer SchmerzVereinigte Staaten
-
Beijing Anzhen HospitalNoch keine RekrutierungAtherosklerotische Herz-Kreislauf-ErkrankungenChina
-
hearX GroupUniversity of PretoriaAbgeschlossen
-
LMC Diabetes & Endocrinology Ltd.Abgeschlossen
-
Kutahya Health Sciences UniversityAbgeschlossenDiabetes mellitus, Typ 2 | Patientenermächtigung | ErmächtigungTruthahn
-
Mohd Khairul Zul Hasymi FirdausPrince of Songkla UniversityAbgeschlossenDiabetes mellitus, Typ 2Malaysia
-
University of AarhusTRYG Foundation; Danish Committee for Health EducationAbgeschlossenChronischer SchmerzDänemark