Collaborative Multidimensional Intervention for Depression in Chile

NCT05016388 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 394

Last updated 2021-08-23

No results posted yet for this study

Summary

This study protocol aims to determine the efficacy of a collaborative multidimensional model (CMD) to improve the results of depression in primary care (PHC) in Chile. The CMD includes training of PHC teams, on the recognition of clinical, functional and psycho-biographic dimensions associated to a complex depression sub-type, difficult to treat, prevalent in PHC in Chile, for which there are no recommendations in current clinical guidelines. This model implies the implementation of a collaborative model, trauma informed care, patient- centered, that includes a case manager, the use of instruments and a close relationship between the PHC team and the specialty level. At least twelve primary care teams belonging to the Maule Region will be randomly assigned to one of the two arms of the study, the CMD group and the current standard model (SM). After the implementation of the CMD, an intentional sample of 394 participants who agreed to participate, with prior informed consent, will be evaluated by a blind research team at the beginning, at three and six months with a battery of instruments. An improvement in depressive symptoms, anxiety and functional variables is expected in participants treated in CMD versus SM. This protocol was approved by the Research Ethics Council of the University of Talca, Talca. The goal is to publish the preliminary results in December 2022.

Conditions

Interventions

OTHER

Collaborative Multidimensional Model (CMD)

The teams enrolled in the CMD intervention will have a 22-hour training that integrates current knowledge of depression with skills for the management of functional variables, interpersonal, social, emotional regulation, and history of biographical adversity from childhood considering the trauma informed care paradigm. After the training, the PHC teams will implement the depression treatment according to a collaborative model.

OTHER

Standard Model (SM)

The teams enrolled in the SM intervention will have a 22-hour training that integrates the current national clinical guide for Depression in Chile. This guide offers a staggered treatment according to the severity of the depression. After the training, the PHC teams will implement the depression treatment according to the SM.

Sponsors & Collaborators

  • National Fund for Research and Development in Health, Chile

    collaborator OTHER
  • University of Talca

    lead OTHER

Principal Investigators

  • Veronica G Vitriol, MD · University of Talca

  • Alfredo A Cancino, MD · University of Talca

  • Maria L Aylwin, PhD · University of Talca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-09-30
Completion
2023-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05016388 on ClinicalTrials.gov