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

Not Applicable

Completed

• Conditions: Depressive Symptoms
• Interventions: Behavioral: Take care of your mood (CUIDA TU ANIMO in Spanish); Other: Control

• Registration Number: NCT03521388
• Lead Sponsor: University of Chile

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-17
• Study Start: 2018-04-18
• Study First Submitted QC: 2018-04-27
• Study First Posted: 2018-05-11
• Primary Completion: 2019-05-31
• Study Completion: 2019-08-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 947

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Take care of your mood (CUIDA TU ANIMO in Spanish)	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.
Control group	Control	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.

Primary Outcome Measures

Name	Time	Method
Depressive Symptoms	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 Outcome Measures

Name	Time	Method
Health-Related Quality of Life Index	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
Depressive Symptoms	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
Anxiety Symptoms	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
Social Problem Solving Skills	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
Dysfunctional Thoughts	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
Emotion Regulation	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
Depression Stigma	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

Trial Locations

Locations (1)

CEMERA, Faculty of Medicine, Universidad de Chile; 🇨🇱 Santiago, Region Metropolitana, Chile