NCT01860443

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable depression

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

2.6 years

First QC Date

May 18, 2013

Last Update Submit

May 15, 2016

Conditions

Keywords

depressionadolescents

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Beck Depression Inventory (BDI)

    Baseline and 12 weeks

Secondary Outcomes (1)

  • Change from baseline in KIDSCREEN-27

    Baseline and 12 weeks

Study Arms (2)

Telepsychiatry collaborative program

EXPERIMENTAL

* 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

Usual care

ACTIVE COMPARATOR

* 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

Interventions

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

Telepsychiatry collaborative program

* Online training for the health staff * Medical and psychological treatment, as described in the AUGE Clinical Guidelines for Depression

Usual care

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CESFAM Alemania, CESFAM Huequén, CESFAM Piedra de Águila

Angol, Chile

Location

CESFAM Dr. Cristóbal Sáenz Cerda

Lautaro, Chile

Location

CESFAM Nueva Imperial

Nueva Imperial, Chile

Location

Consultorio Pitrufquén

Pitrufquén, Chile

Location

CESFAM Amanecer, CESFAM Labranza, CESFAM Pedro de Valdivia, CESFAM Pueblo Nuevo, CESFAM Santa Rosa, CESFAM Villa Alegre, Consultorio Miraflores

Temuco, Chile

Location

Hospital de Vilcún

Vilcún, Chile

Location

CESFAM Villarrica

Villarrica, Chile

Location

Related Publications (1)

  • Martinez V, Rojas G, Martinez P, Zitko P, Irarrazaval M, Luttges C, Araya R. Remote Collaborative Depression Care Program for Adolescents in Araucania Region, Chile: Randomized Controlled Trial. J Med Internet Res. 2018 Jan 31;20(1):e38. doi: 10.2196/jmir.8021.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Vania Martínez-Nahuel, Dr.med.

    University of Chile

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 18, 2013

First Posted

May 22, 2013

Study Start

June 1, 2013

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations