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

Not Applicable

• Conditions: Depression

• Registration Number: NCT03047512
• Lead Sponsor: CES University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-09
• Study Start: 2017-09-20
• Status Verified: 2018-05
• Primary Completion: 2018-05-08
• Last Update Submitted: 2018-05-29
• Last Update Posted: 2018-05-31
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 213

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline Depressive Symptomatology	Baseline, 4 months, 12 months	Depressive symptomatology measured with the Patient Health Questionnaire PHQ -9

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Health Related Quality	Baseline, 4 months, 12 months	Health Related Quality of Life Questionnaire for Children and Young People KIDSCREEN-10
Change from Baseline in anxious symptoms	Baseline, 4 months, 12 months	Generalised Anxiety Disorder Assessment (GAD-7)
Change from Baseline in of depression	Baseline, 4 months, 12 month	Self-Stigma of Depression Scale (SSDS)

Trial Locations

Locations (8)

Institución Educativa America; 🇨🇴 Medellín, Antioquia, Colombia

Institucion Educativa El Salvador; 🇨🇴 Medellín, Antioquia, Colombia

Institución Educativa Fatima Nutibara; 🇨🇴 Medellín, Antioquia, Colombia

Institucion Educativa El Perpetuo Socorro; 🇨🇴 Medellín, Antioquia, Colombia

Institución Educativa Mariscal Robledo; 🇨🇴 Medellín, Antioquia, Colombia

Institución Educativa El Corazón; 🇨🇴 Medellín, Antioquia, Colombia

Institución Educativa Francisco Antonio Zea; 🇨🇴 Medellín, Antioquia, Colombia

Institución Educativa Villa Flora; 🇨🇴 Medellín, Antioquia, Colombia