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

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ClinicalTrials.gov Identifier: NCT03047512
Recruitment Status : Active, not recruiting
First Posted : February 9, 2017
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Henry Daniel Espinosa Duque, CES University

Brief Summary:

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 11 and 20 years of age in 2 schools in the Antioquia Region, Colombia.


Condition or disease Intervention/treatment Phase
Depression Behavioral: Experimental: Internet-based program Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot descriptive study
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Pilot Study of an Internet-based Program for Prevention and Early Intervention of Adolescent Depression
Actual Study Start Date : September 20, 2017
Actual Primary Completion Date : May 8, 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Internet-based program
The internet based program includes the following modules: (1) information and psychoeducational material, (2) symptom monitoring with personalized automatic feedback, (3) forum (peer support moderated by mental health professionals) and (4) chat (individualized support by mental health professionals). It also considers (5) the referral to face-to-face treatment of cases with symptoms that require it. (6) In addition to the web page in the institutions, there will be a monthly health promotion booth during breaks.
Behavioral: Experimental: Internet-based program
  • Adolescents who obtain a score between 2 and 4 on the PHQ-3 will be invited to use the information module, the psychoeducational material and the symptom monitoring with personalized automatic feedback.
  • Adolescents who obtain a score between 5 and 6 on the PHQ-3 will be invited to use, in addition to the above, group forum activities (peer support moderated by mental health professionals) and the possibility of a chat (individualized support by mental health professionals).
  • Adolescents who obtain a score greater than 6 on the PHQ-3 or that have suicidal thoughts will be invited to see the mental health counselor of the institution and the possibility of their reference to face-to-face professional attention will be considered.
Other Name: Cuida tu Animo active group

No Intervention: Control Group
The control group will receive two psychoeducational workshops / conferences. In addition, the adolescents in the control group can participate in the monthly health promotion booths offered by the program.



Primary Outcome Measures :
  1. Change from Baseline Depressive Symptomatology [ Time Frame: Baseline, 4 months, 12 months ]
    Depressive symptomatology measured with the Patient Health Questionnaire PHQ -9


Secondary Outcome Measures :
  1. Change from Baseline in Health Related Quality [ Time Frame: Baseline, 4 months, 12 months ]
    Health Related Quality of Life Questionnaire for Children and Young People KIDSCREEN-10

  2. Change from Baseline in anxious symptoms [ Time Frame: Baseline, 4 months, 12 months ]
    Generalised Anxiety Disorder Assessment (GAD-7)

  3. Change from Baseline in of depression [ Time Frame: Baseline, 4 months, 12 month ]
    Self-Stigma of Depression Scale (SSDS)



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Ages Eligible for Study:   11 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adolescents who study in schools in Antioquia from sixth grade to tenth grade, who can access the internet and a psychological service in case of moderate or severe depressive symptoms.

Exclusion Criteria:

  • High suicide risk defined by: A score equal to or greater than 2 in the question 9 of the PHQ-9A, an adolescent who is undergoing treatment with antidepressants and / or currently attends psychotherapy

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): NCT03047512


Locations
Colombia
Institucion Educativa El Perpetuo Socorro
Medellín, Antioquia, Colombia, 0000
Institucion Educativa El Salvador
Medellín, Antioquia, Colombia, 0000
Institución Educativa America
Medellín, Antioquia, Colombia, 0000
Institución Educativa El Corazón
Medellín, Antioquia, Colombia, 0000
Institución Educativa Fatima Nutibara
Medellín, Antioquia, Colombia, 0000
Institución Educativa Francisco Antonio Zea
Medellín, Antioquia, Colombia, 0000
Institución Educativa Mariscal Robledo
Medellín, Antioquia, Colombia, 0000
Institución Educativa Villa Flora
Medellín, Antioquia, Colombia, 0000
Sponsors and Collaborators
CES University
Investigators
Study Director: Daniel Espinosa, PhD CES University

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, PhD, CES University
ClinicalTrials.gov Identifier: NCT03047512     History of Changes
Other Study ID Numbers: CES55384
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
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 Henry Daniel Espinosa Duque, CES University:
Depression in adolescents
Mental Health
E-mental health
Prevention and Early intervention

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