Internet-based Program for Prevention and Early Intervention of Adolescent Depression

NCT ID: NCT03521388

Last Updated: 2019-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

947 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-18

Study Completion Date

2019-08-31

Brief Summary

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Background: Depression is prevalent and can have devastating effects on the life of adolescents. Computerized intervention programs for depression have shown positive results. There is less evidence in prevention and early treatment for depression in Latin American adolescents.

Purpose: The purpose of this study is to determine whether a stepped internet-based program is effective to prevent and early intervene depression in adolescents attending 9th to 11th grade in eight schools in Santiago, Chile.

Study design: A two-arm cluster-randomized clinical trial will be carried out with approximately 600 adolescents.

Detailed Description

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Conditions

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Depressive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

The intervention consists of an Internet-based program. The program will last 3 months, with subsequent monthly reinforcement sessions for other 3 months.

The program is stepped, so that the more depressive symptomatology the more intensive program and consists of more components.

The students will interact with the program via a monitoring and feedback e-mail with 3 questions of the PHQ--9- adolescent version (1st, 2nd \& 9th question) that they will receive every 2 weeks and a Website that will allow them to access to psycho-educational videos and information. There will also in the Website sections that will provide emergency information, the possibility of a contact via e-mail, and group chats. Adolescents with more depressive symptoms or suicidal risk will be invited to participate in an online counselling appointment or a face to face assessment with a mental health professional of the program.

Group Type EXPERIMENTAL

Take care of your mood (CUIDA TU ANIMO in Spanish)

Intervention Type BEHAVIORAL

The adolescents will be registered in the Website www.cuidatuanimo.org

Control group

The comparison group will receive general psychoeducation of depression in adolescents and will be on the waiting list to receive the intervention in the event that its efficacy is demonstrated.

Group Type OTHER

Control

Intervention Type OTHER

The adolescents will visit the Website www.cuidatuanimo.org, but they can not register

Interventions

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Take care of your mood (CUIDA TU ANIMO in Spanish)

The adolescents will be registered in the Website www.cuidatuanimo.org

Intervention Type BEHAVIORAL

Control

The adolescents will visit the Website www.cuidatuanimo.org, but they can not register

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Attending from ninth grade to eleventh grade in the eight participating schools.
* Informed consent and informed assent.
* Score in the depression questionnaire PHQ-9 adolescent version between 5 and 14.

Exclusion Criteria

* High suicide risk defined by score in question 9 of the PHQ-9 adolescent version of 2 or more.
* Current treatment with antidepressant drugs.
* Current treatment with psychotherapy.
Minimum Eligible Age

13 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Comisión Nacional de Investigación Científica y Tecnológica

OTHER_GOV

Sponsor Role collaborator

Millennium Institute for Research in Depression and Personality (MIDAP)

UNKNOWN

Sponsor Role collaborator

University of Chile

OTHER

Sponsor Role lead

Responsible Party

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Vania Martínez-Nahuel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vania Martinez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Locations

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CEMERA, Faculty of Medicine, Universidad de Chile

Santiago, Santiago Metropolitan, Chile

Site Status

Countries

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Chile

Other Identifiers

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FONDECYT 1161696

Identifier Type: -

Identifier Source: org_study_id

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