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

Depression Clinical Trial

Official title:

A Randomized Controlled Trial of an Internet-based Program for Prevention and Early Intervention of Adolescent Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02780232
• Other study ID #: CES577
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2018
• Est. completion date: September 2019

Study information

• Verified date: May 2018
• Source: CES University
• Contact: Daniel Espinosa, MA
• Phone: 573128095486
• Email: hespinosa[@]ces.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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: 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.

Locations

Country	Name	City	State
Colombia	Institucion Educativa Villaflora	Medellin	Antioquia
Colombia	Institución Educativa El Corazon	Medellín	Antioquia
Colombia	Institucion Educativa El Pedregal	Medellín	Antioquia

Sponsors (4)

Lead Sponsor	Collaborator
CES University	Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), MIDAP Millennium Institute for Research in Depression and Personality, Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

References & Publications (10)

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. — View 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. — View Citation

Fernández, J. & Gómez-Restrepo, C. Telepsiquiatría: innovación de la atención en salud mental. Una perspectiva general. Rev. Colomb. Psiquiat., 40 (3), 2011.

KIDSCREEN Group Europe. The KIDSCREEN questionnaires. Quality of life questionnaires for children and adolescents— Handbook. Lengerich, Germany: Papst Science Publisher. 2006.

Löwe B, Decker O, Müller S, Brähler 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. — View 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.

Proudfoot JG. Computer-based treatment for anxiety and depression: is it feasible? Is it effective? Neurosci Biobehav Rev. 2004 May;28(3):353-63. Review. — View 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. — View Citation

Sobocki P, Jönsson B, Angst J, Rehnberg C. Cost of depression in Europe. J Ment Health Policy Econ. 2006 Jun;9(2):87-98. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Depressive Symptomatology at 3 months and 12 months	Depressive symptomatology measured with the Patient Health Questionnaire PHQ -9 [6]	Baseline, 3 months, 12 months
Secondary	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]	Baseline, 3 months, 12 months
Secondary	Change from Baseline in anxious symptoms at 3 and 12 months	Generalised Anxiety Disorder Assessment (GAD-7) [8]	Baseline, 3 months, 12 months
Secondary	Change from Baseline in of depression at 3 and 12 months	Self-Stigma of Depression Scale (SSDS) [9]	Baseline, 3 months, 12 months