Depression Clinical Trial
Official title:
A Randomized Controlled Trial of an Internet-based Program for Prevention and Early Intervention of Adolescent Depression
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).
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.
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