Pilot Study of an Internet-based Program for Prevention and Early Intervention of Adolescent Depression
NCT ID: NCT03047512
Last Updated: 2018-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
213 participants
INTERVENTIONAL
2017-09-20
2018-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
11 Years
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CES University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Henry Daniel Espinosa Duque
PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniel Espinosa, PhD
Role: STUDY_DIRECTOR
CES University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institucion Educativa El Perpetuo Socorro
Medellín, Antioquia, Colombia
Institucion Educativa El Salvador
Medellín, Antioquia, Colombia
Institución Educativa America
Medellín, Antioquia, Colombia
Institución Educativa El Corazón
Medellín, Antioquia, Colombia
Institución Educativa Fatima Nutibara
Medellín, Antioquia, Colombia
Institución Educativa Francisco Antonio Zea
Medellín, Antioquia, Colombia
Institución Educativa Mariscal Robledo
Medellín, Antioquia, Colombia
Institución Educativa Villa Flora
Medellín, Antioquia, Colombia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sobocki P, Jonsson B, Angst J, Rehnberg C. Cost of depression in Europe. J Ment Health Policy Econ. 2006 Jun;9(2):87-98.
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.
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.
Fernández, J. & Gómez-Restrepo, C. Telepsiquiatría: innovación de la atención en salud mental. Una perspectiva general. Rev. Colomb. Psiquiat., 40 (3), 2011.
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.
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.
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.
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.
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.
KIDSCREEN Group Europe. The KIDSCREEN questionnaires. Quality of life questionnaires for children and adolescents- Handbook. Lengerich, Germany: Papst Science Publisher. 2006.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CES55384
Identifier Type: -
Identifier Source: org_study_id