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

• ClinicalTrials.gov Identifier: NCT03521388
• Recruitment Status: Completed
• First Posted: May 11, 2018
• Last Update Posted: September 27, 2019
• Sponsor: University of Chile
• Collaborators: Comisión Nacional de Investigación Científica y Tecnológica; Millennium Institute for Research in Depression and Personality (MIDAP)
• Information provided by (Responsible Party): Vania Martínez-Nahuel, University of Chile

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Depressive Symptoms	Behavioral: Take care of your mood (CUIDA TU ANIMO in Spanish); Other: Control	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 947 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Efficacy of a Stepped Internet-based Program for Prevention and Early Intervention of Depression in Adolescents
• Actual Study Start Date: April 18, 2018
• Actual Primary Completion Date: May 31, 2019
• Actual Study Completion Date: August 31, 2019

Arms and Interventions

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
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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 19 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Chile

CEMERA, Faculty of Medicine, Universidad de Chile

Santiago, Region Metropolitana, Chile, 8380455

Sponsors and Collaborators

University of Chile

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

More Information

• Responsible Party: Vania Martínez-Nahuel, Principal Investigator, University of Chile
• ClinicalTrials.gov Identifier: NCT03521388
• Other Study ID Numbers: FONDECYT 1161696
• First Posted: May 11, 2018
• Last Update Posted: September 27, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vania Martínez-Nahuel, University of Chile:

depression; adolescence; prevention; early intervention; internet-based

Additional relevant MeSH terms:

Depression; Behavioral Symptoms