Collaborative Multidimensional Intervention for Depression in Chile

NCT ID: NCT05016388

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 394 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-03-31

Brief 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.

Detailed Description

The research design is a cluster randomized clinical trial. Inter-professional teams from at least 12 primary care centers of the Maule area will be randomized in two arms: intervention and control. The intervention arm will receive a training in the collaborative multidimensional model for depression (CMD) and the control arm will be trained in the current clinical guide (SM).

After the CMD implementation, a sample of 394 participants entered to treatment for depression at their respective center will be invited to participate. This sample has been calculated estimating a maximum error of 5 %, a confidence level of 95 %, a power of 80 % a maximum variance of 50 % and a retention of 85 %.

The patients who agreed to participate, will be treated by their respective PHC team and their therapeutic indications will be included in the official clinical records for each participant. Also these patients, after informed consent, will be evaluated by a blind external research team at the beginning, at three and six months with a battery of instrument.

The informed consents will be kept in locked folders. The data obtained by the external evaluators will be confidential, entered into a virtual spreadsheet in a coded form on a server of the U. of Talca through a personal computer. Participant's diagnoses will be coded using the MINI.

A protocol for the management of adverse situations of an emergency nature will be provided.

The results will be presented according to the CONSORT guide for randomized clinical trials, with its extensions to cluster and non-pharmacological interventions.

Analysis of the primary and secondary outcomes will be performed by intention to treat. In the initial analysis, the balance between the characteristics of the different samples will be evaluated and a linear multi-variable regression will be performed to establish differences at 3 and 6 months, adjusting the results according to the initial data, in case of imbalance for all outcomes. A sensitivity analysis based on different assumptions will also be implemented, to investigate the possible effects of missing data. Statistical analysis will be done with SPSS software.

The research protocol was approved by the Ethics Committee of the University of Talca and approved by the Agencia Nacional de Investigación y Desarrollo (ANID), the national institution that audit the project through a follow-up sheet and yearly controls.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Collaborative Multidimensional Model (CMD)

The teams in the CMD group will be composed each of at least a MD, a psychologist, and a social worker. The teams will receive the CMD training and the CMD will be installed in the primary health care (PHC) center. Then, the participants with depression who enter treatment for depression in their respective PHC center, will be enrolled and evaluated by an external team, blind to the interventions at the beginning, three and six months after.

Group Type: EXPERIMENTAL

Collaborative Multidimensional Model (CMD)

Intervention Type: OTHER

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.

Standard Model (SM)

The teams in the SM group will be composed each of at least a MD, a psychologist, and a social worker. The teams will receive the SM training and the SM will be set in the primary health care (PHC) center. Then, the participants with depression who enter treatment for depression in their respective PHC center, will be enrolled and evaluated by an external team, blind to the interventions at the beginning, three and six months after.

Group Type: OTHER

Standard Model (SM)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Intervention; Control

Eligibility Criteria

Inclusion Criteria

• Starting the treatment for depression in Primary Care according the Health Guarantees.
• Confirmed depression diagnosis according to the Mini International Diagnostic Interview Mini International Neuropsychiatric Interview (MINI, Sheehan et al. 1998).

Exclusion Criteria

• Sensory disability
• Inability to provide the informed consent
• not having contact phone number
• Continuing treatment for depression
• High suicidal risk
• Suspected bipolar and psychosis.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Fund for Research and Development in Health, Chile

OTHER

Sponsor Role: collaborator

University of Talca

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Veronica G Vitriol, MD

Role: STUDY_DIRECTOR

University of Talca

Alfredo A Cancino, MD

Role: STUDY_DIRECTOR

University of Talca

Maria L Aylwin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Talca

Central Contacts

Maria L Aylwin, PhD

Role: CONTACT

maaylwin@utalca.cl

56-98-239 1048

Sergio G Guinez, PhD

Role: CONTACT

sguinez@utalca.cl

56-99-619 5268

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Other Identifiers

SA20I0031

Identifier Type: -

Identifier Source: org_study_id