NCT03521388

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
947

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

April 18, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

April 17, 2018

Last Update Submit

September 25, 2019

Conditions

Depressive Symptoms

Keywords

depressionadolescencepreventionearly interventioninternet-based

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Depressive Symptoms

    12 months after baseline assessment

  • Anxiety Symptoms

    6 and 12 months after baseline assessment

  • Health-Related Quality of Life Index

    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

  • +2 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention consists of an Internet-based program. The program will last 3 months, with subsequent monthly reinforcement sessions for other 3 months. The program is stepped, so that the more depressive symptomatology the more intensive program and consists of more components. The students will interact with the program via a monitoring and feedback e-mail with 3 questions of the PHQ--9- adolescent version (1st, 2nd \& 9th question) that they will receive every 2 weeks and a Website that will allow them to access to psycho-educational videos and information. There will also in the Website sections that will provide emergency information, the possibility of a contact via e-mail, and group chats. Adolescents with more depressive symptoms or suicidal risk will be invited to participate in an online counselling appointment or a face to face assessment with a mental health professional of the program.

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

Control group

OTHER

The comparison group will receive general psychoeducation of depression in adolescents and will be on the waiting list to receive the intervention in the event that its efficacy is demonstrated.

Other: Control

Interventions

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

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

Intervention group
ControlOTHER

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

Control group

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CEMERA, Faculty of Medicine, Universidad de Chile

Santiago, Santiago Metropolitan, 8380455, Chile

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Vania Martinez, PhD

    University of Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 17, 2018

First Posted

May 11, 2018

Study Start

April 18, 2018

Primary Completion

May 31, 2019

Study Completion

August 31, 2019

Last Updated

September 27, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)