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

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Experimental: Internet-based program
Sponsored by
CES University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Depression in adolescents, Mental Health, E-mental health, Prevention and Early intervention

Eligibility Criteria

11 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institucion Educativa El Perpetuo Socorro
  • Institucion Educativa El Salvador
  • Institución Educativa America
  • Institución Educativa El Corazón
  • Institución Educativa Fatima Nutibara
  • Institución Educativa Francisco Antonio Zea
  • Institución Educativa Mariscal Robledo
  • Institución Educativa Villa Flora

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Internet-based program

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from Baseline Depressive Symptomatology
Depressive symptomatology measured with the Patient Health Questionnaire PHQ -9

Secondary Outcome Measures

Change from Baseline in Health Related Quality
Health Related Quality of Life Questionnaire for Children and Young People KIDSCREEN-10
Change from Baseline in anxious symptoms
Generalised Anxiety Disorder Assessment (GAD-7)
Change from Baseline in of depression
Self-Stigma of Depression Scale (SSDS)

Full Information

First Posted
February 7, 2017
Last Updated
May 29, 2018
Sponsor
CES University
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1. Study Identification

Unique Protocol Identification Number
NCT03047512
Brief Title
Pilot Study of an Internet-based Program for Prevention and Early Intervention of Adolescent Depression
Official Title
Pilot Study of an Internet-based Program for Prevention and Early Intervention of Adolescent Depression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2017 (Actual)
Primary Completion Date
May 8, 2018 (Actual)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CES University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression in adolescents, Mental Health, E-mental health, Prevention and Early intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot descriptive study
Masking
Participant
Allocation
Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-based program
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Experimental: Internet-based program
Other Intervention Name(s)
Cuida tu Animo active group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Depressive Symptomatology
Description
Depressive symptomatology measured with the Patient Health Questionnaire PHQ -9
Time Frame
Baseline, 4 months, 12 months
Secondary Outcome Measure Information:
Title
Change from Baseline in Health Related Quality
Description
Health Related Quality of Life Questionnaire for Children and Young People KIDSCREEN-10
Time Frame
Baseline, 4 months, 12 months
Title
Change from Baseline in anxious symptoms
Description
Generalised Anxiety Disorder Assessment (GAD-7)
Time Frame
Baseline, 4 months, 12 months
Title
Change from Baseline in of depression
Description
Self-Stigma of Depression Scale (SSDS)
Time Frame
Baseline, 4 months, 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Espinosa, PhD
Organizational Affiliation
CES University
Official's Role
Study Director
Facility Information:
Facility Name
Institucion Educativa El Perpetuo Socorro
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Institucion Educativa El Salvador
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Institución Educativa America
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Institución Educativa El Corazón
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Institución Educativa Fatima Nutibara
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Institución Educativa Francisco Antonio Zea
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Institución Educativa Mariscal Robledo
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Institución Educativa Villa Flora
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
0000
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17007486
Citation
Sobocki P, Jonsson B, Angst J, Rehnberg C. Cost of depression in Europe. J Ment Health Policy Econ. 2006 Jun;9(2):87-98.
Results Reference
background
PubMed Identifier
29702903
Citation
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.
Results Reference
background
PubMed Identifier
20683846
Citation
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.
Results Reference
background
Citation
Fernández, J. & Gómez-Restrepo, C. Telepsiquiatría: innovación de la atención en salud mental. Una perspectiva general. Rev. Colomb. Psiquiat., 40 (3), 2011.
Results Reference
background
PubMed Identifier
21734685
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. No abstract available.
Results Reference
background
PubMed Identifier
18388841
Citation
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.
Results Reference
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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.
Results Reference
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PubMed Identifier
15225977
Citation
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.
Results Reference
background
PubMed Identifier
21041282
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.
Results Reference
background
Citation
KIDSCREEN Group Europe. The KIDSCREEN questionnaires. Quality of life questionnaires for children and adolescents- Handbook. Lengerich, Germany: Papst Science Publisher. 2006.
Results Reference
background

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

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