Training and Supervision Program for Depression Management

NCT02232854 | Completed

• 1 other identifier: 1130230
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 4

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.

Conditions

Depression

Keywords

Depression

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Depressive Symptomatology at 3 months

  Depressive symptomatology measured with the Patient Health Questionnaire - Nine Item (PHQ-9) at 3 months after patient recruitment.

  Baseline , 3 months

• Change from Baseline Depressive Symptomatology at 6 months

  Depressive symptomatology measured with the Patient Health Questionnaire - Nine Item (PHQ-9) at 6 months after patient recruitment.

  Baseline, 6 months.

Secondary Outcomes (5)

• 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.

• Change from Baseline Clinical Outcomes at 3 and 6 months

  Baseline , 3 months, 6 months.

• Use of Health Care services at patient's level

  3 and 6 months after baseline

• Rate of treated depressed cases at Primary Care team level

  12 months before randomization and 12 months after.

Study Arms (2)

Depression training/supervision program

EXPERIMENTAL

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

Behavioral: Depression training/supervision program

Usual Care

NO INTERVENTION

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.

Interventions

Depression training/supervision program BEHAVIORAL

The intervention will be composed of: * Training of Primary Health Care teams to ensure compliance to the "Clinical Guidelines of the Ministry of Health for the Treatment of Depression". Primary Health Care teams will undergo an Objective Structured Clinical Examination (OSCE) for evaluation. * After the training, a focus group between Primary Health Care teams and study researchers will be held in order to address barriers to clinical guidelines implementation. * Primary Health Care clinics' trained administrative staff will contact patients from a call-center to support treatment adherence. * Psychiatrists, using a web-based platform, will supervise the course of the program, the allocated treatments, the patients' progress, and their response to treatment.

Depression training/supervision program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• current depression treatment
• no access to telephone

Sponsors & Collaborators

• University of Chile: lead

Study Sites (4)

CESFAM Garín

Quinta Normal, Santiago Metropolitan, Chile

Location

CESFAM Lo Franco

Quinta Normal, Santiago Metropolitan, Chile

Location

CESFAM Barros Luco

San Miguel, Santiago Metropolitan, Chile

Location

CESFAM Recreo

San Miguel, Santiago Metropolitan, Chile

Location

Related Publications (1)

• Rojas G, Martinez P, Vohringer PA, Martinez V, Castro-Lara A, Fritsch R. Comprehensive technology-assisted training and supervision program to enhance depression management in primary care in Santiago, Chile: study protocol for a cluster randomized controlled trial. Trials. 2015 Jul 24;16:311. doi: 10.1186/s13063-015-0845-4.

  PMID: 26201546 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.med. Psychyatrist

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: September 5, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 25, 2017

Record last verified: 2017-10

Locations

CL (4)