Clinical trial NCT01860443: 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
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Keywords: depression
adolescents
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 143
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in Beck Depression Inventory (BDI)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change from baseline in KIDSCREEN-27
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Angol
country: Chile
facility: CESFAM Alemania, CESFAM Huequén, CESFAM Piedra de Águila
city: Lautaro
country: Chile
facility: CESFAM Dr. Cristóbal Sáenz Cerda
city: Nueva Imperial
country: Chile
facility: CESFAM Nueva Imperial
city: Pitrufquén
country: Chile
facility: Consultorio Pitrufquén
city: Temuco
country: Chile
facility: CESFAM Amanecer, CESFAM Labranza, CESFAM Pedro de Valdivia, CESFAM Pueblo Nuevo, CESFAM Santa Rosa, CESFAM Villa Alegre, Consultorio Miraflores
city: Vilcún
country: Chile
facility: Hospital de Vilcún
city: Villarrica
country: Chile
facility: CESFAM Villarrica
Study officials:
affiliation: University of Chile
name: Vania Martínez-Nahuel, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
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.