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. 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
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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 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.

Official Title
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A Randomized Controlled Trial 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: Cuida tu animo / Care for your mood


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based program<br>Adolescents in the intervention will receive a tailored online program during 3 months. Adolescents interact with the program via a monitoring e-mail that they receive every two weeks (Monitoring) and a website which allows them to access a number of links. | Behavioral: Cuida tu animo / Care for your mood<br>* CUIDA TU ÁNIMO is an online program to adolescents that provides information, education and support related to the care of the mood. Adolescents interact with the program via a monitoring e-mail that they receive every two weeks (Monitoring) and a website which allows them to access a number of links. The website have the following modules: What is 'CUIDA TU ÁNIMO': Description and definition of the program Psycho-educational information: Information about depression, its treatment, and opportunities for prevention How is your mood? (Monitoring): a) Online assessment of symptoms every two weeks during three months with the PHQ-3. b) Feedback Forums. Blog. Appointment (Chat or Phone call). Contact.<br>|
| No Intervention: Treatment as usual<br>-Waiting list control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Depressive Symptomatology at 3 months and 12 months | Depressive symptomatology measured with the Patient Health Questionnaire PHQ -9 [6] | Baseline, 3 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Health Related Quality of Life at 3 and 12 months | Health Related Quality of Life Questionnaire for Children and Young People KIDSCREEN-27 [7] | Baseline, 3 months, 12 months | 
| Change from Baseline in anxious symptoms at 3 and 12 months | Generalised Anxiety Disorder Assessment (GAD-7) [8] | Baseline, 3 months, 12 months | 
| Change from Baseline in of depression at 3 and 12 months | Self-Stigma of Depression Scale (SSDS) [9] | Baseline, 3 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Adolescence, Prevention, Early intervention, E-Mental Health