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Clinical Trials/NCT03521388
NCT03521388
Completed
N/A

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

University of Chile1 site in 1 country947 target enrollmentApril 18, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depressive Symptoms
Sponsor
University of Chile
Enrollment
947
Locations
1
Primary Endpoint
Depressive Symptoms
Status
Completed
Last Updated
6 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 18, 2018
End Date
August 31, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Chile
Responsible Party
Principal Investigator
Principal Investigator

Vania Martínez-Nahuel

Principal Investigator

University of Chile

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Health-Related Quality of Life Index(6 and 12 months after baseline assessment)
  • Depressive Symptoms(12 months after baseline assessment)
  • Anxiety Symptoms(6 and 12 months after baseline assessment)
  • Social Problem Solving Skills(6 and 12 months after baseline assessment)
  • Dysfunctional Thoughts(6 and 12 months after baseline assessment)
  • Emotion Regulation(6 and 12 months after baseline assessment)
  • Depression Stigma(6 and 12 months after baseline assessment)

Study Sites (1)

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