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

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

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.

Study Overview

• Status: Completed
• Conditions: Depressive Symptoms
• Intervention / Treatment: Behavioral: Take care of your mood (CUIDA TU ANIMO in Spanish); Other: Control

• Study Type: Interventional
• Enrollment (Actual): 947
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Region Metropolitana
    • Santiago, Region Metropolitana, Chile, 8380455
      • CEMERA, Faculty of Medicine, Universidad de Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 15 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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); The adolescents will be registered in the Website www.cuidatuanimo.org
Other: Control group; 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; The adolescents will visit the Website www.cuidatuanimo.org, but they can not register

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Chile
• Collaborators: Comisión Nacional de Investigación Científica y Tecnológica; Millennium Institute for Research in Depression and Personality (MIDAP)
• Investigators: Principal Investigator: Vania Martinez, PhD, University of Chile

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2018
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: April 27, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): September 27, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: depression; prevention; early intervention; adolescence; internet-based
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: FONDECYT 1161696

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No