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

NCT ID: NCT02780232

Last Updated: 2018-05-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-11
• Study Completion Date: 2019-09-30

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).

Detailed 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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Internet-based program

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.

Group Type: EXPERIMENTAL

Cuida tu animo / Care for your mood

Intervention Type: 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.

Treatment as usual

-Waiting list control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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:

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

OTHER_GOV

Sponsor Role: collaborator

Universidad de Antioquia

OTHER

Sponsor Role: collaborator

MIDAP Millennium Institute for Research in Depression and Personality

UNKNOWN

Sponsor Role: collaborator

CES University

OTHER

Sponsor Role: lead

Responsible Party

Henry Daniel Espinosa Duque

MA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Espinosa, MA

Role: PRINCIPAL_INVESTIGATOR

CES University

Locations

Institucion Educativa Villaflora

Medellín, Antioquia, Colombia

Site Status: RECRUITING

Institucion Educativa El Pedregal

Medellín, Antioquia, Colombia

Site Status: RECRUITING

Institución Educativa El Corazon

Medellín, Antioquia, Colombia

Site Status: RECRUITING

Countries

Colombia

Central Contacts

Daniel Espinosa, MA

Role: CONTACT

hespinosa@ces.edu.co

573128095486

Mauricio Fernandez, PhD

Role: CONTACT

mauricio.fernandez@udea.edu.co

573113098173

Facility Contacts

Fredy Tabares, Psychologist

Role: primary

(57) 4 2348424

Astrid Restrepo, Psychologist

Role: primary

(57) 4 4274457 ext. 00

Lina M Vallejo, Psychologist

Role: primary

References

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Reference Type: BACKGROUND

PMID: 17007486 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29702903 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20683846 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 21734685 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18388841 (View on PubMed)

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 15225977 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21041282 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

CES577

Identifier Type: -

Identifier Source: org_study_id