Training and Supervision Program for Depression Management

University of Chile

Status: Completed

Conditions: Depression

Treatments: Behavioral: Depression training/supervision program

Study type: Interventional

Funder types: Other

Identifiers

NCT02232854

1130230

Details and patient eligibility

About

According to the literature the management of depressive disorders at primary care level is not always consistent with guidelines. The main objective of this study is to test whether a Comprehensive Technology-Assisted Training and Supervision Program will improve depression management in Primary Health Care clinics in Santiago, Chile.

Full description

A cluster randomized controlled clinical trial will be conducted in four Primary Health Care (PHC) clinics in Santiago, Chile.

The sample selection of the PHC clinics will be performed in two steps. Firstly, two urban municipalities of Santiago Metropolitan Region, Chile, will be randomly selected if they work with the Faculty of Medicine of the U.Chile and have at least two PHC.Municipalities with a high Human Development Index, high percentage of immigrants and older population, and Psychiatry residents working in PHC , will be excluded.Secondly in each selected municipalities,two PHC will be randomly selected for the active and control arm.

To detect a difference of 20%, in a one-sided model, with an alpha of 5% and power of 80%, 152 depressed persons, 76 to each group, will be required for the study. A design effect of 2.42 was estimated. After applying the design effect the sample needed increased to 368 depressed persons. Considering a retention rate of approximately 85%, 434 depressed cases will be needed required for the study, hence 109 cases in each of the 4 primary health care clinics.

Analysis and presentation of the results will be in accordance with CONSORT guidelines for randomized clinical trials, with the primary comparative analysis being conducted on an intention to treat basis and due emphasis placed on confidence intervals for the between-arm comparisons.

Initially descriptive analysis to assess the balance between two groups will be conducted. The primary analysis will employ multilevel multivariable lineal regression to investigate differences in the PHQ-9 scores between groups at 3 and 6 months after randomization, adjusting for baseline outcome variable scores. Sensitivity analysis making different assumptions will be conducted to investigate the potential effects of missing data. Similar analysis will be done for the secondary outcomes measures.

Enrollment: 256 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• signing written informed consent
• age between 18-65 years
• current depressive episode, according to the Mini-International Neuropsychiatric Interview (MINI)

Exclusion criteria

• current depression treatment
• no access to telephone

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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256 participants in 2 patient groups

Depression training/supervision program

Experimental group

Description:

A complex intervention, which will include: * Primary Health Care team training in depression * A focus group, after training * Telephone monitoring of patients * Web-based supervision of clinicians

Treatment:

Behavioral: Depression training/supervision program

Usual Care

No Intervention group

Description:

Patients in the control group will receive all the interventions that are guaranteed for persons with depression in Chile: treatment in Primary Health Care clinics with the Primary Health Care team and referral to the regional specialized psychiatric service.