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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02780232
Enrollment
600
Registered
2016-05-23
Start date
2018-05-11
Completion date
2019-09-30
Last updated
2018-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Depression, Adolescence, Prevention, Early intervention, E-Mental Health

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.

Interventions

BEHAVIORALCuida 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.

Sponsors

Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
CollaboratorOTHER_GOV
Universidad de Antioquia
CollaboratorOTHER
MIDAP Millennium Institute for Research in Depression and Personality
CollaboratorUNKNOWN
CES University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Depressive Symptomatology at 3 months and 12 monthsBaseline, 3 months, 12 monthsDepressive symptomatology measured with the Patient Health Questionnaire PHQ -9 \[6\]

Secondary

MeasureTime frameDescription
Change from Baseline in Health Related Quality of Life at 3 and 12 monthsBaseline, 3 months, 12 monthsHealth Related Quality of Life Questionnaire for Children and Young People KIDSCREEN-27 \[7\]
Change from Baseline in anxious symptoms at 3 and 12 monthsBaseline, 3 months, 12 monthsGeneralised Anxiety Disorder Assessment (GAD-7) \[8\]
Change from Baseline in of depression at 3 and 12 monthsBaseline, 3 months, 12 monthsSelf-Stigma of Depression Scale (SSDS) \[9\]

Countries

Colombia

Contacts

Primary ContactDaniel Espinosa, MA
hespinosa@ces.edu.co573128095486
Backup ContactMauricio Fernandez, PhD
mauricio.fernandez@udea.edu.co573113098173

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026