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

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.

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Behavioral: Experimental: Internet-based program

• Study Type: Interventional
• Enrollment (Actual): 213
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 0000
      • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Depressive Symptomatology	Depressive symptomatology measured with the Patient Health Questionnaire PHQ -9	Baseline, 4 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change from Baseline in anxious symptoms	Generalised Anxiety Disorder Assessment (GAD-7)	Baseline, 4 months, 12 months
Change from Baseline in of depression	Self-Stigma of Depression Scale (SSDS)	Baseline, 4 months, 12 month

Collaborators and Investigators

• Sponsor: CES University
• Investigators: Study Director: Daniel Espinosa, PhD, CES University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2017
• Primary Completion (Actual): May 8, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 29, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Mental Health; Depression in adolescents; E-mental health; Prevention and Early intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: CES55384

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No