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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03521388
Date of registration:	17/04/2018
Prospective Registration:	Yes
Primary sponsor:	University of Chile
Public title:	Internet-based Program for Prevention and Early Intervention of Adolescent Depression
Scientific title:	Efficacy of a Stepped Internet-based Program for Prevention and Early Intervention of Depression in Adolescents
Date of first enrolment:	April 18, 2018
Target sample size:	947
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03521388
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Chile

Contacts

Name:	Vania Martinez, PhD
Address:
Telephone:
Email:
Affiliation:	University of Chile

Key inclusion & exclusion 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.

Age minimum: 13 Years
Age maximum: 19 Years
Gender: All

Health Condition(s) or Problem(s) studied

Depressive Symptoms

Intervention(s)

Other: Control

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

Primary Outcome(s)

Depressive Symptoms [Time Frame: 6 months after baseline assessment]

Secondary Outcome(s)

Dysfunctional Thoughts [Time Frame: 6 and 12 months after baseline assessment]

Emotion Regulation [Time Frame: 6 and 12 months after baseline assessment]

Health-Related Quality of Life Index [Time Frame: 6 and 12 months after baseline assessment]

Anxiety Symptoms [Time Frame: 6 and 12 months after baseline assessment]

Depression Stigma [Time Frame: 6 and 12 months after baseline assessment]

Depressive Symptoms [Time Frame: 12 months after baseline assessment]

Social Problem Solving Skills [Time Frame: 6 and 12 months after baseline assessment]

Secondary ID(s)

FONDECYT 1161696

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Millennium Institute for Research in Depression and Personality (MIDAP)

Comisión Nacional de Investigación Científica y Tecnológica

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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