TY - JOUR
T1 - A collaborative, computer-assisted, psycho-educational intervention for depressed patients with chronic disease at primary care
T2 - protocol for a cluster randomized controlled trial
AU - Rojas, Graciela
AU - Martínez, Pablo
AU - Guajardo, Viviana
AU - Campos, Solange
AU - Herrera, Pablo
AU - Vöhringer, Paul A.
AU - Gómez, Víctor
AU - Szabo, Wilsa
AU - Araya, Ricardo
N1 - Funding Information:
This project is funded by the Chilean National Fund for Scientific and Technological Development, FONDECYT (project number 1180224) and by the ANID Millennium Science Initiative /Millennium Institute for Research on Depression and Personality-MIDAP ICS13_005. GR and PM received funding by ANID – Millennium Science Initiative Program – NCS17_035. VG (Víctor Gómez) received funding from ANID/PFCHA/DOCTORADO NACIONAL/2019–21192050, and WS from ANID/PFCHA/DOCTORADO NACIONAL/2018–21181716. Funding parties have no role in the design, management, analysis, and reporting of the study.
Publisher Copyright:
© 2021, The Author(s).
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/12
Y1 - 2021/12
N2 - 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 3, 6, and 12 months after enrollment. The primary outcome will be depression improvement at 6 months, defined as ≥50% reduction in baseline PHQ-9 scores. Intention-to-treat analyses will be performed. Discussion: This study will be one of the first to provide evidence for the effectiveness of a collaborative, computer-assisted, psycho-educational intervention for depressed patients with chronic disease at primary care in a Latin American country. Trial registration: retrospectively registered in ClinicalTrials.gov, first posted: November 3, 2020, under identifier: NCT04613076.
AB - 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 3, 6, and 12 months after enrollment. The primary outcome will be depression improvement at 6 months, defined as ≥50% reduction in baseline PHQ-9 scores. Intention-to-treat analyses will be performed. Discussion: This study will be one of the first to provide evidence for the effectiveness of a collaborative, computer-assisted, psycho-educational intervention for depressed patients with chronic disease at primary care in a Latin American country. Trial registration: retrospectively registered in ClinicalTrials.gov, first posted: November 3, 2020, under identifier: NCT04613076.
KW - Cluster randomized trial
KW - Cognitive-behavioral
KW - Depression
KW - Diabetes
KW - Hypertension
KW - Primary care
KW - Psychotherapy
KW - Study protocol
UR - http://www.scopus.com/inward/record.url?scp=85113818069&partnerID=8YFLogxK
U2 - 10.1186/s12888-021-03380-2
DO - 10.1186/s12888-021-03380-2
M3 - Article
AN - SCOPUS:85113818069
SN - 1471-244X
VL - 21
JO - BMC Psychiatry
JF - BMC Psychiatry
IS - 1
M1 - 418
ER -
