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Telepsychiatry to Improve the Management of Adolescent Depression in Primary Care

Primary Purpose

Depression

Status
Terminated
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Telepsychiatry collaborative program
Usual care
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, adolescents

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telepsychiatry collaborative program

Usual care

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Change from baseline in Beck Depression Inventory (BDI)

Secondary Outcome Measures

Change from baseline in KIDSCREEN-27
Health-related quality of life questionnaire

Full Information

First Posted
May 18, 2013
Last Updated
May 15, 2016
Sponsor
University of Chile
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1. Study Identification

Unique Protocol Identification Number
NCT01860443
Brief Title
Telepsychiatry to Improve the Management of Adolescent Depression in Primary Care
Official Title
Telepsychiatry-Based Collaborative Program to Improve the Management of Adolescent Depression in Primary Care Clinics in the Araucanía Region, Chile: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
Because there are enough data to present the conclusions
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 To compare the level of depressive symptoms of adolescents suffering depression participating in a telepsychiatry program versus usual care in primary care clinics. 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. To compare adolescents' adherence with a telepsychiatry program versus usual care in primary care clinics. To evaluate adolescents' satisfaction with a telepsychiatry program. To evaluate health staff's satisfaction with a telepsychiatry program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telepsychiatry collaborative program
Arm Type
Experimental
Arm Description
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).
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Telepsychiatry collaborative program
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Online training for the health staff Medical and psychological treatment, as described in the AUGE Clinical Guidelines for Depression
Primary Outcome Measure Information:
Title
Change from baseline in Beck Depression Inventory (BDI)
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in KIDSCREEN-27
Description
Health-related quality of life questionnaire
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vania Martínez-Nahuel, Dr.med.
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
CESFAM Alemania, CESFAM Huequén, CESFAM Piedra de Águila
City
Angol
Country
Chile
Facility Name
CESFAM Dr. Cristóbal Sáenz Cerda
City
Lautaro
Country
Chile
Facility Name
CESFAM Nueva Imperial
City
Nueva Imperial
Country
Chile
Facility Name
Consultorio Pitrufquén
City
Pitrufquén
Country
Chile
Facility Name
CESFAM Amanecer, CESFAM Labranza, CESFAM Pedro de Valdivia, CESFAM Pueblo Nuevo, CESFAM Santa Rosa, CESFAM Villa Alegre, Consultorio Miraflores
City
Temuco
Country
Chile
Facility Name
Hospital de Vilcún
City
Vilcún
Country
Chile
Facility Name
CESFAM Villarrica
City
Villarrica
Country
Chile

12. IPD Sharing Statement

Citations:
PubMed Identifier
29386172
Citation
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.
Results Reference
derived

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Telepsychiatry to Improve the Management of Adolescent Depression in Primary Care

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