Depressive SymptomsNCT03521388
Internet-based Program for Prevention and Early Intervention of Adolescent Depression
A study testing Take care of your mood (CUIDA TU ANIMO in Spanish) in people with Depressive Symptoms, run by University of Chile at 1 site in Chile.
Trial summary
Background: Depression is prevalent and can have devastating effects on the life of adolescents. Computerized intervention programs for depression have shown positive results. There is less evidence in prevention and early treatment for depression in Latin American adolescents. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Take care of your mood (CUIDA TU ANIMO in Spanish)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 947 participants
- Where
- 1 siteChile
- Study dates
- 18 Apr 2018to 31 Aug 2019
- 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 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Attending from ninth grade to eleventh grade in the eight participating schools.
- Informed consent and informed assent.
- Score in the depression questionnaire PHQ-9 adolescent version between 5 and 14.
Who cannot join
- High suicide risk defined by score in question 9 of the PHQ-9 adolescent version of 2 or more.
- Current treatment with antidepressant drugs.
- Current treatment with psychotherapy.
Trial locations and contacts
1 site in 1 country.
Chile1 site
CEMERA, Faculty of Medicine, Universidad de Chile
Santiago, Santiago Metropolitan, 8380455
About this study
Official title: Efficacy of a Stepped Internet-based Program for Prevention and Early Intervention of Depression in Adolescents
Background: Depression is prevalent and can have devastating effects on the life of adolescents. Computerized intervention programs for depression have shown positive results. There is less evidence in prevention and early treatment for depression in Latin American adolescents.
Purpose: The purpose of this study is to determine whether a stepped internet-based program is effective to prevent and early intervene depression in adolescents attending 9th to 11th grade in eight schools in Santiago, Chile.
Study design: A two-arm cluster-randomized clinical trial will be carried out with approximately 600 adolescents.
- Conditions
- Depressive Symptoms
- Being tested
- Take care of your mood (CUIDA TU ANIMO in Spanish), Control
- Keywords
- depression, adolescence, prevention, early intervention, internet-based
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Take care of your mood (CUIDA TU ANIMO in Spanish)Behavioural
The adolescents will be registered in the Website www.cuidatuanimo.org
ControlOther
The adolescents will visit the Website www.cuidatuanimo.org, but they can not register
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention consists of an Internet-based program. The program will last 3 months, with subsequent monthly reinforcement sessions for other 3 months.
The program is stepped, so that the more depressive symptomatology the more intensive program and consists of more components.
The students will interact with the program via a monitoring and feedback e-mail with 3 questions of the PHQ--9- adolescent version (1st, 2nd \& 9th question) that they will receive every 2 weeks and a Website that will allow them to access to psycho-educational videos and information. There will also in the Website sections that will provide emergency information, the possibility of a contact via e-mail, and group chats. Adolescents with more depressive symptoms or suicidal risk will be invited to participate in an online counselling appointment or a face to face assessment with a mental health professional of the program. Receives: Behavioral: Take care of your mood (CUIDA TU ANIMO in Spanish) |
| Control group | Other | The comparison group will receive general psychoeducation of depression in adolescents and will be on the waiting list to receive the intervention in the event that its efficacy is demonstrated. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptoms
Patient Health Questionnaire-9 (PHQ-9) adolescent version, total score varies between 0 and 27, higher values represent a worse outcome
Measured: 6 months after baseline assessment
Secondary outcomes (7)
Depressive Symptoms
Patient Health Questionnaire-9 (PHQ-9) adolescent version, total score varies between 0 and 27, higher values represent a worse outcome
Measured: 12 months after baseline assessment
Anxiety Symptoms
Generalized Anxiety Disorder-7 (GAD-7) adolescent version, total score varies between 0 and 21, higher values represent a worse outcome
Measured: 6 and 12 months after baseline assessment
Health-Related Quality of Life Index
KIDSCREEN-10 index, total score varies between -3.53 and 83.8, higher values represent a better outcome
Measured: 6 and 12 months after baseline assessment
Social Problem Solving Skills
Social Problem Solving Inventory-Revised Short Form (SPSI-RS), positive problem subscale orientation, and rational problem solving subscale, total score of each subscale varies between 0 to 20, higher scores represent better outcome
Measured: 6 and 12 months after baseline assessment
Dysfunctional Thoughts
Children's Automatic Thought Questionnaire (CATS), personal failure subscale, total score of the subscale varies between 0 and 40, higher values represent worse outcome
Measured: 6 and 12 months after baseline assessment
Emotion Regulation
Emotion Regulation Questionnaire (ERQ), reappraisal subscale, total score of the subscale varies between 6 and 42, higher values represent better outcome
Measured: 6 and 12 months after baseline assessment
Depression Stigma
Depression Stigma Scale (DSS), personal stigma subscale, total score of the subscale varies between 0 and 36, higher values represent worse outcome
Measured: 6 and 12 months after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start18 Apr 2018
- Primary completion31 May 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 947 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Comisión Nacional de Investigación Científica y Tecnológica, Millennium Institute for Research in Depression and Personality (MIDAP)
- Responsible party
- Principal investigator, Vania Martínez-Nahuel, University of Chile
- Investigators
- Vania Martinez, PhD, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521388
- Sponsor's protocol ID
- FONDECYT 1161696
- Status last verified
- Sep 2019
- First submitted
- 17 Apr 2018
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Stepped Internet-based Program for Prevention and Early Intervention of Depression in Adolescents
- ClinicalTrials.gov ID
- NCT03521388
- Acronym / sponsor ID
- FONDECYT 1161696
- Conditions
- Depressive Symptoms
- Keywords
- depression, adolescence, prevention, early intervention, internet-based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 947 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Comisión Nacional de Investigación Científica y Tecnológica, Millennium Institute for Research in Depression and Personality (MIDAP)
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Depression is prevalent and can have devastating effects on the life of adolescents. Computerized intervention programs for depression have shown positive results. There is less evidence in prevention and early treatment for depression in Latin American adolescents.
Purpose: The purpose of this study is to determine whether a stepped internet-based program is effective to prevent and early intervene depression in adolescents attending 9th to 11th grade in eight schools in Santiago, Chile.
Study design: A two-arm cluster-randomized clinical trial will be carried out with approximately 600 adolescents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Take care of your mood (CUIDA TU ANIMO in Spanish)The intervention consists of an Internet-based program. The program will last 3 months, with subsequent monthly reinforcement sessions for other 3 months. The program is stepped, so that the more depressive symptomatology the more intensive program and consists of more components. The students will interact with the program via a monitoring and feedback e-mail with 3 questions of the PHQ--9- adolescent version (1st, 2nd \& 9th question) that they will receive every 2 weeks and a Website that will allow them to access to psycho-educational videos and information. There will also in the Website sections that will provide emergency information, the possibility of a contact via e-mail, and group chats. Adolescents with more depressive symptoms or suicidal risk will be invited to participate in an online counselling appointment or a face to face assessment with a mental health professional of the program. |
| Control group | Other | Other: ControlThe comparison group will receive general psychoeducation of depression in adolescents and will be on the waiting list to receive the intervention in the event that its efficacy is demonstrated. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Attending from ninth grade to eleventh grade in the eight participating schools.
- Informed consent and informed assent.
- Score in the depression questionnaire PHQ-9 adolescent version between 5 and 14.
Key exclusion criteria (3 listed)
- High suicide risk defined by score in question 9 of the PHQ-9 adolescent version of 2 or more.
- Current treatment with antidepressant drugs.
- Current treatment with psychotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Take care of your mood (CUIDA TU ANIMO in Spanish)The adolescents will be registered in the Website www.cuidatuanimo.org | Behavioural | Intervention group |
| ControlThe adolescents will visit the Website www.cuidatuanimo.org, but they can not register | Other | Control group |
Primary outcome
Depressive Symptoms
Time frame: 6 months after baseline assessment
Patient Health Questionnaire-9 (PHQ-9) adolescent version, total score varies between 0 and 27, higher values represent a worse outcome
7 secondary outcomes
Depressive Symptoms
Time frame: 12 months after baseline assessment
Anxiety Symptoms
Time frame: 6 and 12 months after baseline assessment
Health-Related Quality of Life Index
Time frame: 6 and 12 months after baseline assessment
Social Problem Solving Skills
Time frame: 6 and 12 months after baseline assessment
Dysfunctional Thoughts
Time frame: 6 and 12 months after baseline assessment
Emotion Regulation
Time frame: 6 and 12 months after baseline assessment
Depression Stigma
Time frame: 6 and 12 months after baseline assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vania Martinez, PhD principal investigator
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Take care of your mood (CUIDA TU ANIMO in Spanish) in people with Depressive Symptoms, run by University of Chile at 1 site in Chile.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Depressive Symptoms (time frame: 6 months after baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2019.