Clinical trial NCT03047512: Pilot Study of an Internet-based Program for Prevention and Early Intervention of Adolescent Depression
Official title: Pilot Study 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 in adolescents
Mental Health
E-mental health
Prevention and Early intervention
Lead sponsor: CES University
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 213
Sex: ALL
Minimum age (years): 11
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot descriptive study
Primary purpose: PREVENTION

Brief summary: 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 11 and 20 years of age in 2 schools in the Antioquia Region, Colombia.


Eligibility criteria: Inclusion Criteria:

* Adolescents who study in schools in Antioquia from sixth grade to tenth grade, who can access the internet and a psychological service in case of moderate or severe depressive symptoms.

Exclusion Criteria:

* High suicide risk defined by: A score equal to or greater than 2 in the question 9 of the PHQ-9A, an adolescent who is undergoing treatment with antidepressants and / or currently attends psychotherapy

Primary outcomes:
measure: Change from Baseline Depressive Symptomatology
timeFrame: Baseline, 4 months, 12 months
Secondary outcomes:
measure: Change from Baseline in Health Related Quality
timeFrame: Baseline, 4 months, 12 months
measure: Change from Baseline in anxious symptoms
timeFrame: Baseline, 4 months, 12 months
measure: Change from Baseline in of depression
timeFrame: Baseline, 4 months, 12 month
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Institucion Educativa El Perpetuo Socorro
state: Antioquia
city: Medellín
country: Colombia
facility: Institucion Educativa El Salvador
state: Antioquia
city: Medellín
country: Colombia
facility: Institución Educativa America
state: Antioquia
city: Medellín
country: Colombia
facility: Institución Educativa El Corazón
state: Antioquia
city: Medellín
country: Colombia
facility: Institución Educativa Fatima Nutibara
state: Antioquia
city: Medellín
country: Colombia
facility: Institución Educativa Francisco Antonio Zea
state: Antioquia
city: Medellín
country: Colombia
facility: Institución Educativa Mariscal Robledo
state: Antioquia
city: Medellín
country: Colombia
facility: Institución Educativa Villa Flora
state: Antioquia
Study officials:
affiliation: CES University
name: Daniel Espinosa, PhD
role: STUDY_DIRECTOR
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citation: Moras, K. Twenty-five years of psychological treatment research on unipolar depression in adult outpatients: Introduction to the special section. Psychotherapy Research , 16 (5), 519-525, 2006.
citation: Proudfoot JG. Computer-based treatment for anxiety and depression: is it feasible? Is it effective? Neurosci Biobehav Rev. 2004 May;28(3):353-63. doi: 10.1016/j.neubiorev.2004.03.008.
citation: Richardson LP, McCauley E, Grossman DC, McCarty CA, Richards J, Russo JE, Rockhill C, Katon W. Evaluation of the Patient Health Questionnaire-9 Item for detecting major depression among adolescents. Pediatrics. 2010 Dec;126(6):1117-23. doi: 10.1542/peds.2010-0852. Epub 2010 Nov 1.
citation: KIDSCREEN Group Europe. The KIDSCREEN questionnaires. Quality of life questionnaires for children and adolescents- Handbook. Lengerich, Germany: Papst Science Publisher. 2006.