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

Wilsa Szabo¹  Víctor Gómez²  Graciela Rojas³  Pablo Martínez⁴  Paul A. Vöhringer⁵  Viviana Guajardo⁶  Ricardo Araya⁷  Solange Campos⁸  Pablo Herrera⁹ 

[1] ANID, Millennium Science Initiative Program, Millennium Institute for Depression and Personality Research (MIDAP), Santiago, Chile;Escuela de Psicología, Facultad de Humanidades, Universidad de Santiago de Chile, Santiago, Chile;Facultad de Medicina, Universidad de Chile, Santiago, Chile;Programa de Doctorado en Psicoterapia, Facultad de Medicina y Facultad de Ciencias Sociales, Universidad de Chile y Pontificia Universidad Católica de Chile, Santiago, Chile;ANID, Millennium Science Initiative Program, Millennium Institute for Depression and Personality Research (MIDAP), Santiago, Chile;Facultad de Medicina, Universidad de Chile, Santiago, Chile;Programa de Doctorado en Psicoterapia, Facultad de Medicina y Facultad de Ciencias Sociales, Universidad de Chile y Pontificia Universidad Católica de Chile, Santiago, Chile;Departamento de Psiquiatría y Salud Mental, Hospital Clínico Universidad de Chile, Avenida La Paz, 1003, Santiago, Chile;ANID, Millennium Science Initiative Program, Millennium Institute for Depression and Personality Research (MIDAP), Santiago, Chile;ANID, Millennium Science Initiative Program, Millennium Nucleus to Improve the Mental Health of Adolescents and Youths, Imhay, Santiago, Chile;ANID, Millennium Science Initiative Program, Millennium Nucleus in Social Development (DESOC), Santiago, Chile;Departamento de Psiquiatría y Salud Mental, Hospital Clínico Universidad de Chile, Avenida La Paz, 1003, Santiago, Chile;ANID, Millennium Science Initiative Program, Millennium Institute for Depression and Personality Research (MIDAP), Santiago, Chile;ANID, Millennium Science Initiative Program, Millennium Nucleus to Improve the Mental Health of Adolescents and Youths, Imhay, Santiago, Chile;Escuela de Psicología, Facultad de Humanidades, Universidad de Santiago de Chile, Santiago, Chile;Psicomedica, Clinical & Research Group, Santiago, Chile;Departamento de Psiquiatría y Salud Mental, Hospital Clínico Universidad de Chile, Avenida La Paz, 1003, Santiago, Chile;ANID, Millennium Science Initiative Program, Millennium Institute for Depression and Personality Research (MIDAP), Santiago, Chile;Escuela de Psicología, Facultad de Humanidades, Universidad de Santiago de Chile, Santiago, Chile;Mood Disorders Program, Tufts Medical Center, Boston, MA, USA;Department of Psychiatry, Tufts University School of Medicine, Boston, MA, USA;Departamento de Psiquiatría y Salud Mental, Hospital Clínico Universidad de Chile, Avenida La Paz, 1003, Santiago, Chile;ANID, Millennium Science Initiative Program, Millennium Institute for Depression and Personality Research (MIDAP), Santiago, Chile;Servicio de Psiquiatría, Hospital El Pino, Santiago, Chile;Department of Health Services and Population Research, King’s College London, London, UK;Escuela de Enfermería, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile;Escuela de Psicología, Facultad de Ciencias Sociales, Universidad de Chile, Santiago, Chile;

关键词: Study protocol;    Cluster randomized trial;    Depression;    Hypertension;    Diabetes;    Primary care;    Cognitive-behavioral;    Psychotherapy;   

DOI  :  10.1186/s12888-021-03380-2

来源: Springer

【 摘 要 】

BackgroundDepression 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.MethodsTwo-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.DiscussionThis 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 registrationretrospectively registered in ClinicalTrials.gov, first posted: November 3, 2020, under identifier: NCT04613076.

【 授权许可】

CC BY