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DepressionNCT03047512

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

A study testing Experimental: Internet-based program in people with Depression, run by CES University at 8 sites in Colombia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 11 to 20 years
Conditions the study is for
Depression
What is being tested?
Experimental: Internet-based program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
213 participants
Where
8 sitesColombia
Study dates
20 Sep 2017to Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Colombia8 sites

  • Institucion Educativa El Perpetuo Socorro

    Medellín, Antioquia, 0000

  • Institucion Educativa El Salvador

    Medellín, Antioquia, 0000

  • Institución Educativa America

    Medellín, Antioquia, 0000

  • Institución Educativa El Corazón

    Medellín, Antioquia, 0000

  • Institución Educativa Fatima Nutibara

    Medellín, Antioquia, 0000

  • Institución Educativa Francisco Antonio Zea

    Medellín, Antioquia, 0000

  • Institución Educativa Mariscal Robledo

    Medellín, Antioquia, 0000

  • Institución Educativa Villa Flora

    Medellín, Antioquia, 0000

Other trials in Colombia

About this study

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.

Read more

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.

Conditions
Depression
Being tested
Experimental: Internet-based program
Keywords
Depression in adolescents, Mental Health, E-mental health, Prevention and Early intervention
Medical subject headings
Depression, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: Internet-based programBehavioural

    Also called Cuida tu Animo active group

    • 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.
Study groups in NCT03047512
Study groupRoleWhat they receive
Internet-based programExperimentalThe 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.
Receives: Behavioral: Experimental: Internet-based program
Control GroupNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Depressive Symptomatology

    Depressive symptomatology measured with the Patient Health Questionnaire PHQ -9

    Measured: Baseline, 4 months, 12 months

Secondary outcomes (3)

  1. Change from Baseline in Health Related Quality

    Health Related Quality of Life Questionnaire for Children and Young People KIDSCREEN-10

    Measured: Baseline, 4 months, 12 months

  2. Change from Baseline in anxious symptoms

    Generalised Anxiety Disorder Assessment (GAD-7)

    Measured: Baseline, 4 months, 12 months

  3. Change from Baseline in of depression

    Self-Stigma of Depression Scale (SSDS)

    Measured: Baseline, 4 months, 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2017 (estimated)
  2. Study start20 Sep 2017
  3. Primary completion8 May 2018
  4. Study completionSep 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pilot descriptive study
Masking
Single blind
Who is masked
Participant
Enrolment
213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03047512
Sponsor's protocol ID
CES55384
Status last verified
May 2018
First submitted
7 Feb 2017
Last updated
31 May 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 17007486

  • 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.

    PubMed 29702903

  • 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.

    PubMed 20683846

  • 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.

    PubMed 21734685

  • 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.

    PubMed 18388841

  • 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.

    PubMed 15225977

  • 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.

    PubMed 21041282

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

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: Internet-based program in people with Depression, run by CES University at 8 sites in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Depressive Symptomatology (time frame: Baseline, 4 months, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03047512, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2018.

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Clinical Trial NCT03047512 | AzTrials