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

Study Overview
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Brief Summary
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Experimental: Internet-based program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot descriptive study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based program<br>The internet based program includes the following modules: (1) information and psychoeducational material, (2) symptom monitoring with personalized automatic feedback, (3) forum (peer support moderated by mental health professionals) and (4) chat (individualized support by mental health professionals). It also considers (5) the referral to face-to-face treatment of cases with symptoms that require it. (6) In addition to the web page in the institutions, there will be a monthly health promotion booth during breaks. | Behavioral: Experimental: Internet-based program<br>* Adolescents who obtain a score between 2 and 4 on the PHQ-3 will be invited to use the information module, the psychoeducational material and the symptom monitoring with personalized automatic feedback. Adolescents who obtain a score between 5 and 6 on the PHQ-3 will be invited to use, in addition to the above, group forum activities (peer support moderated by mental health professionals) and the possibility of a chat (individualized support by mental health professionals). Adolescents who obtain a score greater than 6 on the PHQ-3 or that have suicidal thoughts will be invited to see the mental health counselor of the institution and the possibility of their reference to face-to-face professional attention will be considered.<br>* Other names: Cuida tu Animo active group;|
| No Intervention: Control Group<br>The control group will receive two psychoeducational workshops / conferences. In addition, the adolescents in the control group can participate in the monthly health promotion booths offered by the program. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Depressive Symptomatology | Depressive symptomatology measured with the Patient Health Questionnaire PHQ -9 | Baseline, 4 months, 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression in adolescents, Mental Health, E-mental health, Prevention and Early intervention