Clinical trial NCT02780232: An Internet-based Program for Prevention and Early Intervention of Adolescent Depression
Official title: A Randomized Controlled Trial of an Internet-based Program for Prevention and Early Intervention of Adolescent Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Depression
Adolescence
Prevention
Early intervention
E-Mental Health
Lead sponsor: CES University
Sponsor class: OTHER
Collaborators: name: Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
name: Universidad de Antioquia
name: MIDAP Millennium Institute for Research in Depression and Personality
First posted: 2016-05-23
Enrollment: 600
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Depressive Symptomatology at 3 months and 12 months
timeFrame: Baseline, 3 months, 12 months
Secondary outcomes:
measure: Change from Baseline in Health Related Quality of Life at 3 and 12 months
timeFrame: Baseline, 3 months, 12 months
measure: Change from Baseline in anxious symptoms at 3 and 12 months
timeFrame: Baseline, 3 months, 12 months
measure: Change from Baseline in of depression at 3 and 12 months
timeFrame: Baseline, 3 months, 12 months
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Institucion Educativa Villaflora
state: Antioquia
city: Medellín
country: Colombia
facility: Institucion Educativa El Pedregal
state: Antioquia
city: Medellín
country: Colombia
facility: Institución Educativa El Corazon
state: Antioquia
Study officials:
affiliation: CES University
name: Daniel Espinosa, MA
role: PRINCIPAL_INVESTIGATOR
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