Telepsychiatry to Improve the Management of Adolescent Depression in Primary Care

Sponsor

University of Chile (Other)

Overall Status

Terminated

CT.gov ID

NCT01860443

Collaborator

(none)

143

Enrollment

Locations

Arms

Duration (Months)

20.4

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Other: Telepsychiatry collaborative program Other: Usual care	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

143 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telepsychiatry collaborative program 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 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
Active Comparator: Usual care 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 Online training for the health staff Medical and psychological treatment, as described in the AUGE Clinical Guidelines for Depression

Arm

Intervention/Treatment

Experimental: Telepsychiatry collaborative program

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

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

Active Comparator: Usual care

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

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

Outcome Measures

Primary Outcome Measures

Change from baseline in Beck Depression Inventory (BDI) [Baseline and 12 weeks]

Secondary Outcome Measures

Change from baseline in KIDSCREEN-27 [Baseline and 12 weeks]
Health-related quality of life questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 19 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	CESFAM Alemania, CESFAM Huequén, CESFAM Piedra de Águila	Angol	Chile
2	CESFAM Dr. Cristóbal Sáenz Cerda	Lautaro	Chile
3	CESFAM Nueva Imperial	Nueva Imperial	Chile
4	Consultorio Pitrufquén	Pitrufquén	Chile
5	CESFAM Amanecer, CESFAM Labranza, CESFAM Pedro de Valdivia, CESFAM Pueblo Nuevo, CESFAM Santa Rosa, CESFAM Villa Alegre, Consultorio Miraflores	Temuco	Chile
6	Hospital de Vilcún	Vilcún	Chile
7	CESFAM Villarrica	Villarrica	Chile

Sponsors and Collaborators

University of Chile

Investigators

Principal Investigator: Vania Martínez-Nahuel, Dr.med., University of Chile

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vania Martínez-Nahuel, Dr.med., University of Chile

ClinicalTrials.gov Identifier:

NCT01860443

Other Study ID Numbers:

FONIS SA12I1294

First Posted:

May 22, 2013

Last Update Posted:

May 17, 2016

Last Verified:

May 1, 2016

Keywords provided by Vania Martínez-Nahuel, Dr.med., University of Chile

depression

adolescents

Additional relevant MeSH terms:

Depression

Depressive Disorder

Study Results

No Results Posted as of May 17, 2016