NCT04613076

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

Completed NA Last updated 6 December 2023

What this trial tests

NA trial testing "Me cuido y me siento mejor" in Depression in 359 participants. Completed in 31 December 2022.

Timeline

3 September 2019

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	University of Chile
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	359
Start date	3 September 2019
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	1 location across Chile

Drugs / interventions tested

• "Me cuido y me siento mejor"
• Enhanced Usual Treatment

Conditions studied

• Depression — all drugs for Depression →

Sponsor

University of Chile

Who can join

18 and older, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A collaborative, computer-assisted, psycho-educational intervention for depressed patients with chronic disease at primary care: protocol for a cluster randomized controlled trial.
   Rojas G, Martínez P, Guajardo V, Campos S, et al · · 2021 · cited 5× · PMID 34419010 · DOI 10.1186/s12888-021-03380-2