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

C

CES University

Status

Unknown

Conditions

Depression

Treatments

Behavioral: Cuida tu animo / Care for your mood

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

Major depression is a highly prevalent and severe mental disease. Interventions based on information and communication technologies (ICTs) generate innovative opportunities to prevent and to intervene early the depression in adolescents. In Colombia, there are few preventive mental health interventions scientifically oriented and seeking to demonstrate efficacy in context.

The purpose of this study is to determine whether an internet-based program is effective to prevent and to intervene early the depression in adolescents between 13 and 19 years of age in 8 schools of the Antioquia Region, Colombia .

Study design: A cluster-randomized clinical trial will be carried out with 600 adolescents. The efficacy, adherence, and acceptability of the internet-based program will be evaluated. A single-blind randomized controlled trial will be conducted with two arms, the intervention arm (n=300), which will receive an internet-based program for depression, and the TAU (Treatment As Usual) arm (n=300).

Full description

Major depression is a highly prevalent and severe mental disease that negatively alters the lives of people, their families, and their social environment.

Organizations that promote mental health policies have recognized the potential of new information technologies for the prevention and treatment of mental disorders. In this direction, information and communication technologies (ICTs) generate opportunities for increasing patient well-being through the use of on-line software. Such programs often include interactivity, self-monitoring, information materials (sometimes in multimedia format), and exercises on problem solving, recognition and challenging of dysfunctional thoughts, scheduling of activities, behavioral experiments, and other psycho-educational activities.

In Colombia, there are few preventive mental health interventions scientifically oriented and seeking to demonstrate efficacy in context.

The purpose of this study is to determine whether an internet-based program is effective to prevent and to intervene early the depression in adolescents between 13 and 19 years of age in 8 schools in the Antioquia Region, Colombia.

Study design: A cluster-randomized clinical trial will be carried out with 600 adolescents. The efficacy, adherence, and acceptability of the internet-based program will be evaluated. A single-blind randomized controlled trial will be conducted with two arms, the intervention arm (n=300), which will receive an internet-based program for depression, and the TAU arm (n=300).

Follow-up times: T = 0 baseline, T= 3 months (post-intervention), T=12 months.

Enrollment

600 estimated patients

Sex

All

Ages

13 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Young students in schools of Antioquia between 6 and 11 high school degree, with internet access and available psychological service, foreseeing that moderate or severe depressive symptoms may be found.

Exclusion criteria

  • Young students with high suicide risk defined by: score equal to or greater than 2 in question 9 of PHQ-9; students who are receiving at the time treatment with antidepressant drugs and / or currently attending psychotherapy.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

600 participants in 2 patient groups

Internet-based program
Experimental group
Description:
Adolescents in the intervention will receive a tailored online program during 3 months. Adolescents interact with the program via a monitoring e-mail that they receive every two weeks (Monitoring) and a website which allows them to access a number of links.
Treatment:
Behavioral: Cuida tu animo / Care for your mood
Treatment as usual
No Intervention group
Description:
-Waiting list control group.

Trial contacts and locations

3

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Central trial contact

Mauricio Fernandez, PhD; Daniel Espinosa, MA

Data sourced from clinicaltrials.gov

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