Technology-assisted Collaborative Care Program for Depressed Patients With Chronic Disease at Primary Care

University of Chile

Status: Completed

Conditions: Depression

Treatments: Behavioral: "Me cuido y me siento mejor"; Behavioral: Enhanced Usual Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04613076

1180224

Details and patient eligibility

About

Background: depression and chronic diseases are frequently comorbid public health problems. However, clinical guidelines often fail to consider comorbidities. This study protocol describes a cluster randomized trial (CRT) aimed to compare the effectiveness of a collaborative, computer-assisted, psycho-educational intervention versus enhanced usual care (EUC) in the treatment of depressed patients with hypertension and/or diabetes in primary care clinics (PCC) in Santiago, Chile.

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.

Enrollment: 359 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 or older.
• 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

• Functional illiteracy (i.e., patients unable to read and comprehend written information, such as the study questionnaires or written informed consent).
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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359 participants in 2 patient groups

"Me cuido y me siento mejor"

Experimental group

Description:

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.

Treatment:

Behavioral: "Me cuido y me siento mejor"

Enhanced Usual Treatment

Active Comparator group

Description:

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.

Treatment:

Behavioral: Enhanced Usual Treatment