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

This study is not yet open for participant recruitment.
Verified May 2016 by Henry Daniel Espinosa Duque, CES University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02780232
First Posted: May 23, 2016
Last Update Posted: May 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Universidad de Antioquia
MIDAP Millennium Institute for Research in Depression and Personality
Information provided by (Responsible Party):
Henry Daniel Espinosa Duque, CES University
  Purpose

Major depression is a highly prevalent and severe mental disease. Interventions based on information and communication technologies (ICTs) generate innovative opportunities to prevent and to intervene early the depression in adolescents. In Colombia, there are few preventive mental health interventions scientifically oriented and seeking to demonstrate efficacy in context.

The purpose of this study is to determine whether an internet-based program is effective to prevent and to intervene early the depression in adolescents between 13 and 19 years of age in 8 schools of the Antioquia Region, Colombia .

Study design: A cluster-randomized clinical trial will be carried out with 600 adolescents. The efficacy, adherence, and acceptability of the internet-based program will be evaluated. A single-blind randomized controlled trial will be conducted with two arms, the intervention arm (n=300), which will receive an internet-based program for depression, and the TAU (Treatment As Usual) arm (n=300).


Condition Intervention
Depression Behavioral: Cuida tu animo / Care for your mood

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of an Internet-based Program for Prevention and Early Intervention of Adolescent Depression

Further study details as provided by Henry Daniel Espinosa Duque, CES University:

Primary Outcome Measures:
  • Change from Baseline Depressive Symptomatology at 3 months and 12 months [ Time Frame: Baseline, 3 months, 12 months ]
    Depressive symptomatology measured with the Patient Health Questionnaire PHQ -9 [6]


Secondary Outcome Measures:
  • Change from Baseline in Health Related Quality of Life at 3 and 12 months [ Time Frame: Baseline, 3 months, 12 months ]
    Health Related Quality of Life Questionnaire for Children and Young People KIDSCREEN-27 [7]

  • Change from Baseline in anxious symptoms at 3 and 12 months [ Time Frame: Baseline, 3 months, 12 months ]
    Generalised Anxiety Disorder Assessment (GAD-7) [8]

  • Change from Baseline in of depression at 3 and 12 months [ Time Frame: Baseline, 3 months, 12 months ]
    Self-Stigma of Depression Scale (SSDS) [9]


Estimated Enrollment: 600
Study Start Date: February 2018
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Internet-based program

Adolescents in the intervention will receive a tailored online program during 3 months.

Adolescents interact with the program via a monitoring e-mail that they receive every two weeks (Monitoring) and a website which allows them to access a number of links.

Behavioral: Cuida tu animo / Care for your mood

CUIDA TU ÁNIMO is an online program to adolescents that provides information, education and support related to the care of the mood.

Adolescents interact with the program via a monitoring e-mail that they receive every two weeks (Monitoring) and a website which allows them to access a number of links. The website have the following modules:

  1. What is 'CUIDA TU ÁNIMO': Description and definition of the program
  2. Psycho-educational information: Information about depression, its treatment, and opportunities for prevention
  3. How is your mood? (Monitoring): a) Online assessment of symptoms every two weeks during three months with the PHQ-3. b) Feedback
  4. Forums.
  5. Blog.
  6. Appointment (Chat or Phone call).
  7. Contact.
No Intervention: Treatment as usual
-Waiting list control group.

Detailed Description:

Major depression is a highly prevalent and severe mental disease that negatively alters the lives of people, their families, and their social environment.

Organizations that promote mental health policies have recognized the potential of new information technologies for the prevention and treatment of mental disorders. In this direction, information and communication technologies (ICTs) generate opportunities for increasing patient well-being through the use of on-line software. Such programs often include interactivity, self-monitoring, information materials (sometimes in multimedia format), and exercises on problem solving, recognition and challenging of dysfunctional thoughts, scheduling of activities, behavioral experiments, and other psycho-educational activities.

In Colombia, there are few preventive mental health interventions scientifically oriented and seeking to demonstrate efficacy in context.

The purpose of this study is to determine whether an internet-based program is effective to prevent and to intervene early the depression in adolescents between 13 and 19 years of age in 8 schools in the Antioquia Region, Colombia.

Study design: A cluster-randomized clinical trial will be carried out with 600 adolescents. The efficacy, adherence, and acceptability of the internet-based program will be evaluated. A single-blind randomized controlled trial will be conducted with two arms, the intervention arm (n=300), which will receive an internet-based program for depression, and the TAU arm (n=300).

Follow-up times: T = 0 baseline, T= 3 months (post-intervention), T=12 months.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Young students in schools of Antioquia between 6 and 11 high school degree, with internet access and available psychological service, foreseeing that moderate or severe depressive symptoms may be found.

Exclusion Criteria:

  • Young students with high suicide risk defined by: score equal to or greater than 2 in question 9 of PHQ-9; students who are receiving at the time treatment with antidepressant drugs and / or currently attending psychotherapy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780232


Contacts
Contact: Daniel Espinosa, MA 573128095486 danielespinosaduque@gmail.com
Contact: Mauricio Fernandez, PhD 573113098173 mauricio.fernandez@udea.edu.co

Sponsors and Collaborators
CES University
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Universidad de Antioquia
MIDAP Millennium Institute for Research in Depression and Personality
Investigators
Principal Investigator: Daniel Espinosa, MA CES University
  More Information

Publications:
Vargas-Zea, et al. Colombian Health System on its Way to Improve Allocation Efficiency—Transition from a Health Sector Reform to the Settlement of an HTA Agency. Value in Health Regional Issues. 1 (2). 2012.
Fernández, J. & Gómez-Restrepo, C. Telepsiquiatría: innovación de la atención en salud mental. Una perspectiva general. Rev. Colomb. Psiquiat., 40 (3), 2011.
Moras, K. Twenty-five years of psychological treatment research on unipolar depression in adult outpatients: Introduction to the special section. Psychotherapy Research , 16 (5), 519-525, 2006.
KIDSCREEN Group Europe. The KIDSCREEN questionnaires. Quality of life questionnaires for children and adolescents— Handbook. Lengerich, Germany: Papst Science Publisher. 2006.

Responsible Party: Henry Daniel Espinosa Duque, MA, CES University
ClinicalTrials.gov Identifier: NCT02780232     History of Changes
Other Study ID Numbers: CES577
First Submitted: May 18, 2016
First Posted: May 23, 2016
Last Update Posted: May 24, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Henry Daniel Espinosa Duque, CES University:
Depression
Adolescence
Prevention
Early intervention
E-Mental Health

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders