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Completed

NCT Number: NCT03521388

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

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.

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Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Depression

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CEMERA, Faculty of Medicine, Universidad de Chile

Santiago, Santiago Metropolitan, 8380455, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Take care of your mood (CUIDA TU ANIMO in Spanish)

Behavioral

The adolescents will be registered in the Website www.cuidatuanimo.org

Control

Other

The adolescents will visit the Website www.cuidatuanimo.org, but they can not register

Primary outcomes

  1. Depressive Symptoms

    Time frame: 6 months after baseline assessment

    Patient Health Questionnaire-9 (PHQ-9) adolescent version, total score varies between 0 and 27, higher values represent a worse outcome

Secondary outcomes

  1. Depressive Symptoms

    Time frame: 12 months after baseline assessment

    Patient Health Questionnaire-9 (PHQ-9) adolescent version, total score varies between 0 and 27, higher values represent a worse outcome

  2. Anxiety Symptoms

    Time frame: 6 and 12 months after baseline assessment

    Generalized Anxiety Disorder-7 (GAD-7) adolescent version, total score varies between 0 and 21, higher values represent a worse outcome

  3. Health-Related Quality of Life Index

    Time frame: 6 and 12 months after baseline assessment

    KIDSCREEN-10 index, total score varies between -3.53 and 83.8, higher values represent a better outcome

  4. Social Problem Solving Skills

    Time frame: 6 and 12 months after baseline assessment

    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

  5. Dysfunctional Thoughts

    Time frame: 6 and 12 months after baseline assessment

    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. Emotion Regulation

    Time frame: 6 and 12 months after baseline assessment

    Emotion Regulation Questionnaire (ERQ), reappraisal subscale, total score of the subscale varies between 6 and 42, higher values represent better outcome

  7. Depression Stigma

    Time frame: 6 and 12 months after baseline assessment

    Depression Stigma Scale (DSS), personal stigma subscale, total score of the subscale varies between 0 and 36, higher values represent worse outcome

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Collaborators

  • Comisión Nacional de Investigación Científica y Tecnológica
  • Millennium Institute for Research in Depression and Personality (MIDAP)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 11, 2018
Registry last updated
Sep 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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