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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03521388
Other study ID # FONDECYT 1161696
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 18, 2018
Est. completion date August 31, 2019

Study information

Verified date September 2019
Source University of Chile
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: Depression is prevalent and can have devastating effects on the life of adolescents. Computerized intervention programs for depression have shown positive results. There is less evidence in prevention and early treatment for depression in Latin American adolescents.

Purpose: The purpose of this study is to determine whether a stepped internet-based program is effective to prevent and early intervene depression in adolescents attending 9th to 11th grade in eight schools in Santiago, Chile.

Study design: A two-arm cluster-randomized clinical trial will be carried out with approximately 600 adolescents.


Recruitment information / eligibility

Status Completed
Enrollment 947
Est. completion date August 31, 2019
Est. primary completion date May 31, 2019
Accepts healthy volunteers No
Gender All
Age group 13 Years to 19 Years
Eligibility Inclusion Criteria:

- Attending from ninth grade to eleventh grade in the eight participating schools.

- Informed consent and informed assent.

- Score in the depression questionnaire PHQ-9 adolescent version between 5 and 14.

Exclusion Criteria:

- High suicide risk defined by score in question 9 of the PHQ-9 adolescent version of 2 or more.

- Current treatment with antidepressant drugs.

- Current treatment with psychotherapy.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Take care of your mood (CUIDA TU ANIMO in Spanish)
The adolescents will be registered in the Website www.cuidatuanimo.org
Other:
Control
The adolescents will visit the Website www.cuidatuanimo.org, but they can not register

Locations

Country Name City State
Chile CEMERA, Faculty of Medicine, Universidad de Chile Santiago Region Metropolitana

Sponsors (3)

Lead Sponsor Collaborator
University of Chile Comisión Nacional de Investigación Científica y Tecnológica, Millennium Institute for Research in Depression and Personality (MIDAP)

Country where clinical trial is conducted

Chile, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depressive Symptoms Patient Health Questionnaire-9 (PHQ-9) adolescent version, total score varies between 0 and 27, higher values represent a worse outcome 6 months after baseline assessment
Secondary Depressive Symptoms Patient Health Questionnaire-9 (PHQ-9) adolescent version, total score varies between 0 and 27, higher values represent a worse outcome 12 months after baseline assessment
Secondary Anxiety Symptoms Generalized Anxiety Disorder-7 (GAD-7) adolescent version, total score varies between 0 and 21, higher values represent a worse outcome 6 and 12 months after baseline assessment
Secondary Health-Related Quality of Life Index KIDSCREEN-10 index, total score varies between -3.53 and 83.8, higher values represent a better outcome 6 and 12 months after baseline assessment
Secondary Social Problem Solving Skills Social Problem Solving Inventory-Revised Short Form (SPSI-RS), positive problem subscale orientation, and rational problem solving subscale, total score of each subscale varies between 0 to 20, higher scores represent better outcome 6 and 12 months after baseline assessment
Secondary Dysfunctional Thoughts Children's Automatic Thought Questionnaire (CATS), personal failure subscale, total score of the subscale varies between 0 and 40, higher values represent worse outcome 6 and 12 months after baseline assessment
Secondary Emotion Regulation Emotion Regulation Questionnaire (ERQ), reappraisal subscale, total score of the subscale varies between 6 and 42, higher values represent better outcome 6 and 12 months after baseline assessment
Secondary Depression Stigma Depression Stigma Scale (DSS), personal stigma subscale, total score of the subscale varies between 0 and 36, higher values represent worse outcome 6 and 12 months after baseline assessment
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