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

Depressive Symptoms Clinical Trial

Official title:

Efficacy of a Stepped Internet-based Program for Prevention and Early Intervention of Depression in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03521388
• Other study ID #: FONDECYT 1161696
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

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