Technology-assisted Collaborative Care Program for Depressed Patients With Chronic Disease at Primary Care
NCT ID: NCT04613076
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
359 participants
INTERVENTIONAL
2019-09-03
2022-12-31
Brief Summary
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Methods: two-arm, single-blind, CRT carried out at two municipalities in Santiago, Chile. Eight PCC will be randomly assigned (1:1 ratio within each municipality, 4 PCC in each municipality) to the INTERVENTION or EUC. A total of 360 depressed patients, aged at least 18 years, with Patient Health Questionnaire-9 Item \[PHQ-9\] scores ≥ 15, and enrolled in the Cardiovascular Health Program at the participating PCC. Patients with alcohol/substance abuse; current treatment for depression, bipolar disorder, or psychosis; illiteracy; severe impairment; and resident in long-term care facilities, will be excluded. Patients in both arms will be invited to use the Web page of the project, which includes basic health education information. Patients in the INTERVENTION will receive eight sessions of a computer-assisted, psycho-educational intervention delivered by trained therapists, a structured telephone calls to monitor progress, and usual medical care for chronic diseases. Therapists will receive biweekly and monthly supervision by psychologist and psychiatrist, respectively. A monthly meeting will be held between the PCC team and a member of the research team to ensure continuity of care. Patients in EUC will receive depression treatment according to clinical guidelines and usual medical care for chronic diseases. Outcome assessments will be conducted at three, six, and twelve months after enrollment. The primary outcome will be depression improvement at six months, defined as ≥ 50% reduction in baseline PHQ-9 scores. Intention-to-treat analyses will be performed.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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"Me cuido y me siento mejor"
Patients in the primary care clinics assigned to the intervention will receive eight sessions of a computer-assisted, psycho-educational intervention delivered by trained therapists; structured telephone calls by social worker to monitor clinical progress and treatment adherence; usual medical care for chronic diseases; and access to the project's website, which will be populated with information about the project's aims, the research team, and contact data, along with educational material related to depression, diabetes and hypertension, and healthy lifestyles. Study therapists will receive biweekly and monthly supervision by psychologist and psychiatrist, respectively. A monthly meeting will be held between the PCC team and a member of the research team to ensure continuity of care.
"Me cuido y me siento mejor"
A multicomponent, collaborative, computer-assisted, psycho-educational intervention for the management of depressive symptoms in primary care patients with diabetes and/or hypertension.
Enhanced Usual Treatment
The patients in the primary care clinics assigned to the comparator will receive the usual treatment for depression and their physical conditions -all the guaranteed interventions for people with depression, hypertension, and/or diabetes in primary care, according to the Clinical Guidelines for the Treatment of Depression- and their associated basket of health benefits included in the Regime of Explicit Health Care Guarantees. They will have access to the project's website, which will be populated with information about the project's aims, the research team, and contact data, along with educational material related to depression, diabetes and hypertension, and healthy lifestyles.
Enhanced Usual Treatment
Enhanced Usual Treatment
Interventions
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"Me cuido y me siento mejor"
A multicomponent, collaborative, computer-assisted, psycho-educational intervention for the management of depressive symptoms in primary care patients with diabetes and/or hypertension.
Enhanced Usual Treatment
Enhanced Usual Treatment
Eligibility Criteria
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Inclusion Criteria
* Enrolled in the Cardiovascular Health Program (i.e. currently receiving treatment for diabetes and/or hypertension) at the study primary care clinics.
* Patient Health Questionnaire-9 Item (PHQ-9) score ≥ 15.
* Signed informed consent.
Exclusion Criteria
* Significant visual and/or auditive impairments (i.e., such as those imposing a serious difficulty to respond the study questionnaires or written informed consent).
* Pregnancy or breastfeeding.
* Cognitive impairment - ineligible patients would give a negative answer to questions "What year is it?" and "Where are we (place/address)?".
* In treatment for bipolar and/or psychotic disorder.
* Current psychological treatment for depression.
* High risk of developing alcohol/substance abuse problems, according to an Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) score ≥ 27.
18 Years
ALL
No
Sponsors
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Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
OTHER_GOV
University of Chile
OTHER
Responsible Party
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Graciela Rojas Castillo
Professor
Principal Investigators
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Graciela Rojas
Role: PRINCIPAL_INVESTIGATOR
University of Chile
Locations
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Dirección de Salud Municipal I. Municipalidad de El Bosque
Santiago, , Chile
Countries
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References
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Rojas G, Martinez P, Guajardo V, Campos S, Herrera P, Vohringer PA, Gomez V, Szabo W, Araya R. A collaborative, computer-assisted, psycho-educational intervention for depressed patients with chronic disease at primary care: protocol for a cluster randomized controlled trial. BMC Psychiatry. 2021 Aug 21;21(1):418. doi: 10.1186/s12888-021-03380-2.
Other Identifiers
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1180224
Identifier Type: -
Identifier Source: org_study_id