NCT02780232

An Internet-based Program for Prevention and Early Intervention of Adolescent Depression

A Randomized Controlled Trial of an Internet-based Program for Prevention and Early Intervention of Adolescent Depression

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: CES University · Academic / Other
• Sex: All
• Age: 13 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Cuida tu animo / Care for your mood	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: 1. What is 'CUIDA TU ÁNIMO': Description and definition of the program 2. Psycho-educational information: Information about depression, its treatment, and opportunities for prevention 3. How is your mood? (Monitoring): a) Online assessment of symptoms every two weeks during three months with the PHQ-3. b) Feedback 4. Forums. 5. Blog. 6. Appointment (Chat or Phone call). 7. Contact.

Timeline

• Start date: 2018-05-11
• Primary completion: 2018-09-01
• Completion: 2019-09-01
• First posted: 2016-05-23
• Last updated: 2018-05-31

Locations

3 sites across 1 country: Colombia