Telepsychiatry to Improve the Management of Adolescent Depression in Primary Care

Depression Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01860443
• Other study ID #: FONIS SA12I1294
• Status: Terminated
• Phase: N/A
• First received: May 18, 2013
• Last updated: October 31, 2015
• Start date: June 2013
• Est. completion date: February 2016

Study information

• Verified date: October 2015
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 143
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 19 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Beck Depression Inventory (BDI)		Baseline and 12 weeks	No
Secondary	Change from baseline in KIDSCREEN-27	Health-related quality of life questionnaire	Baseline and 12 weeks	No