A Randomized Controlled Trial of an Internet-based Program for Prevention and Early Intervention of Adolescent Depression
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- CES University
- Enrollment
- 600
- Locations
- 3
- Primary Endpoint
- Change from Baseline Depressive Symptomatology at 3 months and 12 months
- Last Updated
- 7 years ago
Overview
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.
Investigators
Henry Daniel Espinosa Duque
MA
CES University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change from Baseline Depressive Symptomatology at 3 months and 12 months
Time Frame: Baseline, 3 months, 12 months
Depressive symptomatology measured with the Patient Health Questionnaire PHQ -9 \[6\]
Secondary Outcomes
- Change from Baseline in anxious symptoms at 3 and 12 months(Baseline, 3 months, 12 months)
- Change from Baseline in Health Related Quality of Life at 3 and 12 months(Baseline, 3 months, 12 months)
- Change from Baseline in of depression at 3 and 12 months(Baseline, 3 months, 12 months)