Brief Summary

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 11 and 20 years of age in 2 schools in the Antioquia Region, Colombia.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

213

participants targeted

Target at P75+ for not_applicable depression

Timeline

Completed

Started Sep 2017

Shorter than P25 for not_applicable depression

Geographic Reach

1 country

8 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12 months study duration

First Submitted

Initial submission to the registry

February 7, 2017

Completed

2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed

7 months until next milestone

Study Start

First participant enrolled

September 20, 2017

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2018

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed

Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

8 months

First QC Date

February 7, 2017

Last Update Submit

May 29, 2018

Conditions

Depression

Keywords

Depression in adolescentsMental HealthE-mental healthPrevention and Early intervention

Outcome Measures

Primary Outcomes (1)

Change from Baseline Depressive Symptomatology
Depressive symptomatology measured with the Patient Health Questionnaire PHQ -9
Baseline, 4 months, 12 months

Secondary Outcomes (3)

Change from Baseline in Health Related Quality
Baseline, 4 months, 12 months
Change from Baseline in anxious symptoms
Baseline, 4 months, 12 months
Change from Baseline in of depression
Baseline, 4 months, 12 month

Study Arms (2)

Internet-based program

EXPERIMENTAL

The internet based program includes the following modules: (1) information and psychoeducational material, (2) symptom monitoring with personalized automatic feedback, (3) forum (peer support moderated by mental health professionals) and (4) chat (individualized support by mental health professionals). It also considers (5) the referral to face-to-face treatment of cases with symptoms that require it. (6) In addition to the web page in the institutions, there will be a monthly health promotion booth during breaks.

Behavioral: Experimental: Internet-based program

Control Group

NO INTERVENTION

The control group will receive two psychoeducational workshops / conferences. In addition, the adolescents in the control group can participate in the monthly health promotion booths offered by the program.

Interventions

Experimental: Internet-based programBEHAVIORAL

* Adolescents who obtain a score between 2 and 4 on the PHQ-3 will be invited to use the information module, the psychoeducational material and the symptom monitoring with personalized automatic feedback. * Adolescents who obtain a score between 5 and 6 on the PHQ-3 will be invited to use, in addition to the above, group forum activities (peer support moderated by mental health professionals) and the possibility of a chat (individualized support by mental health professionals). * Adolescents who obtain a score greater than 6 on the PHQ-3 or that have suicidal thoughts will be invited to see the mental health counselor of the institution and the possibility of their reference to face-to-face professional attention will be considered.

Also known as: Cuida tu Animo active group

Internet-based program

Eligibility Criteria

Age11 Years - 20 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Adolescents who study in schools in Antioquia from sixth grade to tenth grade, who can access the internet and a psychological service in case of moderate or severe depressive symptoms.

You may not qualify if:

High suicide risk defined by: A score equal to or greater than 2 in the question 9 of the PHQ-9A, an adolescent who is undergoing treatment with antidepressants and / or currently attends psychotherapy

Contact the study team to confirm eligibility.