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Clinical Trials/NCT03047512
NCT03047512
Unknown
N/A

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

CES University8 sites in 1 country213 target enrollmentSeptember 20, 2017
ConditionsDepression

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depression
Sponsor
CES University
Enrollment
213
Locations
8
Primary Endpoint
Change from Baseline Depressive Symptomatology
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 20, 2017
End Date
September 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
CES University
Responsible Party
Principal Investigator
Principal Investigator

Henry Daniel Espinosa Duque

PhD

CES University

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

Outcomes

Primary Outcomes

Change from Baseline Depressive Symptomatology

Time Frame: Baseline, 4 months, 12 months

Depressive symptomatology measured with the Patient Health Questionnaire PHQ -9

Secondary Outcomes

  • Change from Baseline in anxious symptoms(Baseline, 4 months, 12 months)
  • Change from Baseline in of depression(Baseline, 4 months, 12 month)
  • Change from Baseline in Health Related Quality(Baseline, 4 months, 12 months)

Study Sites (8)

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