An Internet-based Program for Prevention and Early Intervention of Adolescent Depression
- Conditions
- Depression
- Interventions
- Behavioral: Cuida tu animo / Care for your mood
- Registration Number
- NCT02780232
- Lead Sponsor
- CES University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Internet-based program Cuida tu animo / Care for your mood 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.
- Primary Outcome Measures
Name Time Method Change from Baseline Depressive Symptomatology at 3 months and 12 months Baseline, 3 months, 12 months Depressive symptomatology measured with the Patient Health Questionnaire PHQ -9 \[6\]
- Secondary Outcome Measures
Name Time Method Change from Baseline in anxious symptoms at 3 and 12 months Baseline, 3 months, 12 months Generalised Anxiety Disorder Assessment (GAD-7) \[8\]
Change from Baseline in Health Related Quality of Life at 3 and 12 months Baseline, 3 months, 12 months Health Related Quality of Life Questionnaire for Children and Young People KIDSCREEN-27 \[7\]
Change from Baseline in of depression at 3 and 12 months Baseline, 3 months, 12 months Self-Stigma of Depression Scale (SSDS) \[9\]
Trial Locations
- Locations (3)
Institución Educativa El Corazon
🇨🇴Medellín, Antioquia, Colombia
Institucion Educativa Villaflora
🇨🇴Medellin, Antioquia, Colombia
Institucion Educativa El Pedregal
🇨🇴Medellín, Antioquia, Colombia