Clinical trial NCT04613076: Technology-assisted Collaborative Care Program for Depressed Patients With Chronic Disease at Primary Care
Official title: A Collaborative, Computer-assisted, Psycho-educational Intervention for Depressed Patients With Chronic Disease at Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Cluster Randomized Controlled Trial
Depression
Hypertension
Diabetes
Primary Care
Psychotherapy
Cognitive-Behavioral
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
First posted: 2020-11-03
Enrollment: 359
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Depression change
timeFrame: Even though the primary outcome is taken at six-month follow-up, this measure will also be reported at three- and twelve-month follow-up.
Secondary outcomes:
measure: Proportion of patients who change their depressive status
timeFrame: Three-, six-, and twelve-month follow-up.
measure: Health-related quality of life
timeFrame: Three-, six-, and twelve-month follow-up.
measure: Social solving problem skills
timeFrame: Three-, six-, and twelve-month follow-up.
measure: Proportion of participants with change in blood pressure
timeFrame: Three-, six-, and twelve-month follow-up.
measure: Ad-hoc questionnaire for the assessment of the acceptability of depression treatment
timeFrame: Three-, six-, and twelve-month follow-up.
measure: Proportion of participants with change in glycosylated hemoglobin
timeFrame: Three-, six-, and twelve-month follow-up.
Other outcomes:
measure: Utilization of health care services
timeFrame: Three-, six-, and twelve-month follow-up.
Locations:
city: Santiago
country: Chile
facility: Dirección de Salud Municipal I. Municipalidad de El Bosque
Study officials:
affiliation: University of Chile
name: Graciela Rojas
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.