Telepsychiatry to Improve the Management of Adolescent Depression in Primary Care

May 15, 2016 updated by: Vania Martínez-Nahuel, University of Chile

Telepsychiatry-Based Collaborative Program to Improve the Management of Adolescent Depression in Primary Care Clinics in the Araucanía Region, Chile: A Randomized Controlled Trial

Background: Depression is common in adolescents and it is associated with serious consequences. In Chile, primary care team has a leading role in the management of depression in adolescents. Nevertheless, the majority of primary care professionals report not feeling adequately prepared to take on this responsibility and having difficulties referring patients to specialists. This situation is particularity complex in regions far away from the central zone. Telepsychiatry is a potential solution to an equitable access to specialized clinical expertise.

Purpose: The purpose of this study is to determine whether a telepsychiatry-based collaborative program is effective to improve the management of depression in adolescents between 13 and 19 years of age in 16 primary care clinics in the Araucanía Region, Chile.

Study design: A cluster-randomized clinical trial will be carried out with 237 adolescents. The efficacy, adherence, and acceptability of the telepsychiatry-based collaborative program will be evaluated.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

General aim To carry out a randomized controlled trial to compare the efficacy of telepsychiatry intervention versus usual care to treat depression in adolescents in primary care clinics in the Araucanía Region, Chile.

Specific aims

  1. To compare the level of depressive symptoms of adolescents suffering depression participating in a telepsychiatry program versus usual care in primary care clinics.
  2. To compare the level of health-related quality of life (HRQoL) of adolescents suffering depression participating in a telepsychiatry program versus usual care in primary care clinics.
  3. To compare adolescents' adherence with a telepsychiatry program versus usual care in primary care clinics.
  4. To evaluate adolescents' satisfaction with a telepsychiatry program.
  5. To evaluate health staff's satisfaction with a telepsychiatry program.

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Angol, Chile
        • CESFAM Alemania, CESFAM Huequén, CESFAM Piedra de Águila
      • Lautaro, Chile
        • CESFAM Dr. Cristóbal Sáenz Cerda
      • Nueva Imperial, Chile
        • CESFAM Nueva Imperial
      • Pitrufquén, Chile
        • Consultorio Pitrufquén
      • Temuco, Chile
        • CESFAM Amanecer, CESFAM Labranza, CESFAM Pedro de Valdivia, CESFAM Pueblo Nuevo, CESFAM Santa Rosa, CESFAM Villa Alegre, Consultorio Miraflores
      • Vilcún, Chile
        • Hospital de Vilcún
      • Villarrica, Chile
        • CESFAM Villarrica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meets diagnostic criteria of a depressive disorder according a structured interview (MINI-KID)

Exclusion Criteria:

  • Psychotic symptoms
  • Bipolar disorder
  • Current substance and/or alcohol dependence
  • Suicide risk that requires specialized treatment
  • Current treatment with antidepressant and/or psychotherapy
  • Low intellectual abilities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telepsychiatry collaborative program
  • Online training on the diagnosis and management of adolescent depression for health professionals from primary care clinics participating in active branch.
  • Clinical management of depression by primary care professionals, according to algorithms based on the Clinical Guidelines of the Chilean Ministry of Health (MINSAL).
  • Supervision of primary care professionals through an internet site run by a team of specialists.
  • Telephone monitoring of patients by personnel trained on clinical progress, treatment adherence, and side effects (applicable for patients taking drugs).
Other: Telepsychiatry collaborative program

The intervention includes:

  • Online training for the health staff
  • Medical and psychological treatment, as described in the AUGE Clinical Guidelines for Depression
  • Online supervision in a web platform by specialists
  • Telephone monitoring
Active Comparator: Usual care
  • Online training on the diagnosis and management of adolescent depression for health professionals from primary care centers participating in active branch.
  • Clinical management of depression by primary care professionals, according to algorithms based on the Clinical Guidelines of the Chilean Ministry of Health (MINSAL).
Other: Usual care
  • Online training for the health staff
  • Medical and psychological treatment, as described in the AUGE Clinical Guidelines for Depression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Beck Depression Inventory (BDI)
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in KIDSCREEN-27
Time Frame: Baseline and 12 weeks
Health-related quality of life questionnaire
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

May 18, 2013

First Submitted That Met QC Criteria

May 18, 2013

First Posted (Estimate)

May 22, 2013

Study Record Updates

Last Update Posted (Estimate)

May 17, 2016

Last Update Submitted That Met QC Criteria

May 15, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FONIS SA12I1294

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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