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Clinical Trials/NCT01860443
NCT01860443TerminatedNot Applicable

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

University of Chile7 sites in 1 country143 target enrollmentStarted: June 1, 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
143
Locations
7
Primary Endpoint
Change from baseline in Beck Depression Inventory (BDI)

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
13 Years to 19 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change from baseline in Beck Depression Inventory (BDI)

Time Frame: Baseline and 12 weeks

Secondary Outcomes

  • Change from baseline in KIDSCREEN-27(Baseline and 12 weeks)

Investigators

Sponsor
University of Chile
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Vania Martínez-Nahuel

Dr.med.

University of Chile

Study Sites (7)

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