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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03047512
• Other study ID #: CES55384
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 20, 2017
• Est. completion date: September 2018

Study information

• Verified date: May 2018
• Source: CES University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 213
• Est. completion date: September 2018
• Est. primary completion date: May 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
Colombia	Institución Educativa America	Medellín	Antioquia
Colombia	Institución Educativa El Corazón	Medellín	Antioquia
Colombia	Institucion Educativa El Perpetuo Socorro	Medellín	Antioquia
Colombia	Institucion Educativa El Salvador	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

Sponsors (1)

Lead Sponsor	Collaborator
CES University

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	Depressive symptomatology measured with the Patient Health Questionnaire PHQ -9	Baseline, 4 months, 12 months
Secondary	Change from Baseline in Health Related Quality	Health Related Quality of Life Questionnaire for Children and Young People KIDSCREEN-10	Baseline, 4 months, 12 months
Secondary	Change from Baseline in anxious symptoms	Generalised Anxiety Disorder Assessment (GAD-7)	Baseline, 4 months, 12 months
Secondary	Change from Baseline in of depression	Self-Stigma of Depression Scale (SSDS)	Baseline, 4 months, 12 month