An interventional study of Cuida tu animo / Care for your mood in Depression, sponsored by CES University. Status unknown at 3 sites in Colombia. Open to participants aged 13 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-31.
Sponsored by CES University · Not applicable, Interventional, and Prevention
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).
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 600 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →CES University is the lead sponsor of 28 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
-Waiting list control group.
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.
Change from Baseline Depressive Symptomatology at 3 months and 12 months
Depressive symptomatology measured with the Patient Health Questionnaire PHQ -9 \[6\]
Time frame: Baseline, 3 months, 12 months
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 \[7\]
Time frame: Baseline, 3 months, 12 months
Change from Baseline in anxious symptoms at 3 and 12 months
Generalised Anxiety Disorder Assessment (GAD-7) \[8\]
Time frame: Baseline, 3 months, 12 months
Change from Baseline in of depression at 3 and 12 months
Self-Stigma of Depression Scale (SSDS) \[9\]
Time frame: Baseline, 3 months, 12 months
Plan to share: Undecided
This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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CES University