An Internet-based Program for Prevention and Early Intervention of Adolescent Depression
Primary Purpose
Depression
Status
Unknown status
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Cuida tu animo / Care for your mood
Sponsored by
About this trial
This is an interventional prevention trial for Depression focused on measuring Depression, Adolescence, Prevention, Early intervention, E-Mental Health
Eligibility 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.
Sites / Locations
- Institucion Educativa VillafloraRecruiting
- Institucion Educativa El PedregalRecruiting
- Institución Educativa El CorazonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Internet-based program
Treatment as usual
Arm Description
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.
-Waiting list control group.
Outcomes
Primary Outcome Measures
Change from Baseline Depressive Symptomatology at 3 months and 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
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
Generalised Anxiety Disorder Assessment (GAD-7) [8]
Change from Baseline in of depression at 3 and 12 months
Self-Stigma of Depression Scale (SSDS) [9]
Full Information
NCT ID
NCT02780232
First Posted
May 18, 2016
Last Updated
May 29, 2018
Sponsor
CES University
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
1. Study Identification
Unique Protocol Identification Number
NCT02780232
Brief Title
An Internet-based Program for Prevention and Early Intervention of Adolescent Depression
Official Title
A Randomized Controlled Trial of an Internet-based Program for Prevention and Early Intervention of Adolescent Depression
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 11, 2018 (Actual)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CES University
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Adolescence, Prevention, Early intervention, E-Mental Health
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Internet-based program
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
-Waiting list control group.
Intervention Type
Behavioral
Intervention Name(s)
Cuida tu animo / Care for your mood
Intervention Description
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:
What is 'CUIDA TU ÁNIMO': Description and definition of the program
Psycho-educational information: Information about depression, its treatment, and opportunities for prevention
How is your mood? (Monitoring): a) Online assessment of symptoms every two weeks during three months with the PHQ-3. b) Feedback
Forums.
Blog.
Appointment (Chat or Phone call).
Contact.
Primary Outcome Measure Information:
Title
Change from Baseline Depressive Symptomatology at 3 months and 12 months
Description
Depressive symptomatology measured with the Patient Health Questionnaire PHQ -9 [6]
Time Frame
Baseline, 3 months, 12 months
Secondary Outcome Measure Information:
Title
Change from Baseline in Health Related Quality of Life at 3 and 12 months
Description
Health Related Quality of Life Questionnaire for Children and Young People KIDSCREEN-27 [7]
Time Frame
Baseline, 3 months, 12 months
Title
Change from Baseline in anxious symptoms at 3 and 12 months
Description
Generalised Anxiety Disorder Assessment (GAD-7) [8]
Time Frame
Baseline, 3 months, 12 months
Title
Change from Baseline in of depression at 3 and 12 months
Description
Self-Stigma of Depression Scale (SSDS) [9]
Time Frame
Baseline, 3 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Espinosa, MA
Phone
573128095486
Email
hespinosa@ces.edu.co
First Name & Middle Initial & Last Name or Official Title & Degree
Mauricio Fernandez, PhD
Phone
573113098173
Email
mauricio.fernandez@udea.edu.co
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Espinosa, MA
Organizational Affiliation
CES University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institucion Educativa Villaflora
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
00000
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fredy Tabares, Psychologist
Phone
(57) 4 2348424
Facility Name
Institucion Educativa El Pedregal
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
0000
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Astrid Restrepo, Psychologist
Phone
(57) 4 4274457
Ext
00
Facility Name
Institución Educativa El Corazon
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
050034
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lina M Vallejo, Psychologist
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17007486
Citation
Sobocki P, Jonsson B, Angst J, Rehnberg C. Cost of depression in Europe. J Ment Health Policy Econ. 2006 Jun;9(2):87-98.
Results Reference
background
PubMed Identifier
29702903
Citation
Vargas-Zea N, Castro H, Rodriguez-Paez F, Tellez D, Salazar-Arias R. Colombian Health System on its Way to Improve Allocation Efficiency-Transition from a Health Sector Reform to the Settlement of an HTA Agency. Value Health Reg Issues. 2012 Dec;1(2):218-222. doi: 10.1016/j.vhri.2012.09.004. Epub 2012 Dec 12.
Results Reference
background
PubMed Identifier
20683846
Citation
Barney LJ, Griffiths KM, Christensen H, Jorm AF. The Self-Stigma of Depression Scale (SSDS): development and psychometric evaluation of a new instrument. Int J Methods Psychiatr Res. 2010 Dec;19(4):243-54. doi: 10.1002/mpr.325.
Results Reference
background
Citation
Fernández, J. & Gómez-Restrepo, C. Telepsiquiatría: innovación de la atención en salud mental. Una perspectiva general. Rev. Colomb. Psiquiat., 40 (3), 2011.
Results Reference
background
PubMed Identifier
21734685
Citation
Collins PY, Patel V, Joestl SS, March D, Insel TR, Daar AS; Scientific Advisory Board and the Executive Committee of the Grand Challenges on Global Mental Health; Anderson W, Dhansay MA, Phillips A, Shurin S, Walport M, Ewart W, Savill SJ, Bordin IA, Costello EJ, Durkin M, Fairburn C, Glass RI, Hall W, Huang Y, Hyman SE, Jamison K, Kaaya S, Kapur S, Kleinman A, Ogunniyi A, Otero-Ojeda A, Poo MM, Ravindranath V, Sahakian BJ, Saxena S, Singer PA, Stein DJ. Grand challenges in global mental health. Nature. 2011 Jul 6;475(7354):27-30. doi: 10.1038/475027a. No abstract available.
Results Reference
background
PubMed Identifier
18388841
Citation
Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093.
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
15225977
Citation
Proudfoot JG. Computer-based treatment for anxiety and depression: is it feasible? Is it effective? Neurosci Biobehav Rev. 2004 May;28(3):353-63. doi: 10.1016/j.neubiorev.2004.03.008.
Results Reference
background
PubMed Identifier
21041282
Citation
Richardson LP, McCauley E, Grossman DC, McCarty CA, Richards J, Russo JE, Rockhill C, Katon W. Evaluation of the Patient Health Questionnaire-9 Item for detecting major depression among adolescents. Pediatrics. 2010 Dec;126(6):1117-23. doi: 10.1542/peds.2010-0852. Epub 2010 Nov 1.
Results Reference
background
Citation
KIDSCREEN Group Europe. The KIDSCREEN questionnaires. Quality of life questionnaires for children and adolescents- Handbook. Lengerich, Germany: Papst Science Publisher. 2006.
Results Reference
background
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An Internet-based Program for Prevention and Early Intervention of Adolescent Depression
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