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

NCT02780232 | Unknown

• 1 other identifier: CES577
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 3

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).

Conditions

Depression

Keywords

Depression; Adolescence; Prevention; Early intervention; E-Mental Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change from Baseline in Health Related Quality of Life at 3 and 12 months

  Baseline, 3 months, 12 months

• Change from Baseline in anxious symptoms at 3 and 12 months

  Baseline, 3 months, 12 months

• Change from Baseline in of depression at 3 and 12 months

  Baseline, 3 months, 12 months

Study Arms (2)

Internet-based program

EXPERIMENTAL

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.

Behavioral: Cuida tu animo / Care for your mood

Treatment as usual

NO INTERVENTION

-Waiting list control group.

Interventions

Cuida tu animo / Care for your mood BEHAVIORAL

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: 1. What is 'CUIDA TU ÁNIMO': Description and definition of the program 2. Psycho-educational information: Information about depression, its treatment, and opportunities for prevention 3. How is your mood? (Monitoring): a) Online assessment of symptoms every two weeks during three months with the PHQ-3. b) Feedback 4. Forums. 5. Blog. 6. Appointment (Chat or Phone call). 7. Contact.

Internet-based program

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CES University: lead
• Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS): collaborator
• Universidad de Antioquia: collaborator
• MIDAP Millennium Institute for Research in Depression and Personality: collaborator

Study Sites (3)

Institucion Educativa Villaflora

Medellín, Antioquia, 00000, Colombia

RECRUITING

Institucion Educativa El Pedregal

Medellín, Antioquia, 0000, Colombia

RECRUITING

Institución Educativa El Corazon

Medellín, Antioquia, 050034, Colombia

RECRUITING

Related Publications (10)

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

  PMID: 17007486 BACKGROUND

• 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.

  PMID: 29702903 BACKGROUND

• 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.

  PMID: 20683846 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 21734685 BACKGROUND

• 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.

  PMID: 18388841 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 15225977 BACKGROUND

• 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.

  PMID: 21041282 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Daniel Espinosa, MA

  CES University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Espinosa, MA

CONTACT

573128095486; hespinosa@ces.edu.co

Mauricio Fernandez, PhD

CONTACT

573113098173; mauricio.fernandez@udea.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MA

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 23, 2016
• Study Start: May 11, 2018
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2019
• Last Updated: May 31, 2018

Record last verified: 2018-05

Locations

CO (3)