Training and Supervision Program for Depression Management

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Depression training/supervision program

• Registration Number: NCT02232854
• Lead Sponsor: University of Chile

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-08-07
• Study First Submitted QC: 2014-09-02
• Study First Posted: 2014-09-05
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Depression training/supervision program	Depression training/supervision program	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

Primary Outcome Measures

Name	Time	Method
Change from Baseline Depressive Symptomatology at 3 months	Baseline , 3 months	Depressive symptomatology measured with the Patient Health Questionnaire - Nine Item (PHQ-9) at 3 months after patient recruitment.
Change from Baseline Depressive Symptomatology at 6 months	Baseline, 6 months.	Depressive symptomatology measured with the Patient Health Questionnaire - Nine Item (PHQ-9) at 6 months after patient recruitment.

Secondary Outcome Measures

Name	Time	Method
Use of Health Care services at patient's level	3 and 6 months after baseline	Use of Health Care services at patient's level measured with and ad-hoc built questionnaire.
Adherence to depression treatment at patient's level	3 and 6 months after baseline.
Change from Baseline Quality of life at 3 and 6 months	Baseline , 3 months, 6 months.	Quality of life at patient's level measured with the Health Survey, Short form (SF-36), at 3 months and 6 months after patient recruitment.
Change from Baseline Clinical Outcomes at 3 and 6 months	Baseline , 3 months, 6 months.	Clinical outcomes at patient's level measured with the Outcome Questionnaire-45.2 (OQ-45.2), at 3 months and 6 months after patient recruitment.
Rate of treated depressed cases at Primary Care team level	12 months before randomization and 12 months after.

Trial Locations

Locations (4)

CESFAM Lo Franco; 🇨🇱 Quinta Normal, Santiago, Chile

CESFAM Garín; 🇨🇱 Quinta Normal, Santiago, Chile

CESFAM Barros Luco; 🇨🇱 San Miguel, Santiago, Chile

CESFAM Recreo; 🇨🇱 San Miguel, Santiago, Chile