DepressionNCT01860443
Telepsychiatry to Improve the Management of Adolescent Depression in Primary Care
A study testing Telepsychiatry collaborative program in people with Depression, run by University of Chile at 7 sites in Chile.
Trial summary
Background: Depression is common in adolescents and it is associated with serious consequences. In Chile, primary care team has a leading role in the management of depression in adolescents. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Depression
- What is being tested?
- Telepsychiatry collaborative program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 7 sitesChile
- Study dates
- Jun 2013to Feb 2016
- 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
- Meets diagnostic criteria of a depressive disorder according a structured interview (MINI-KID)
Who cannot join
- Psychotic symptoms
- Bipolar disorder
- Current substance and/or alcohol dependence
- Suicide risk that requires specialized treatment
- Current treatment with antidepressant and/or psychotherapy
- Low intellectual abilities
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Chile7 sites
CESFAM Alemania, CESFAM Huequén, CESFAM Piedra de Águila
Angol
CESFAM Dr. Cristóbal Sáenz Cerda
Lautaro
CESFAM Nueva Imperial
Nueva Imperial
Consultorio Pitrufquén
Pitrufquén
CESFAM Amanecer, CESFAM Labranza, CESFAM Pedro de Valdivia, CESFAM Pueblo Nuevo, CESFAM Santa Rosa, CESFAM Villa Alegre, Consultorio Miraflores
Temuco
Hospital de Vilcún
Vilcún
CESFAM Villarrica
Villarrica
About this study
Official title: Telepsychiatry-Based Collaborative Program to Improve the Management of Adolescent Depression in Primary Care Clinics in the Araucanía Region, Chile: A Randomized Controlled Trial
Background: Depression is common in adolescents and it is associated with serious consequences. In Chile, primary care team has a leading role in the management of depression in adolescents. Nevertheless, the majority of primary care professionals report not feeling adequately prepared to take on this responsibility and having difficulties referring patients to specialists. This situation is particularity complex in regions far away from the central zone. Telepsychiatry is a potential solution to an equitable access to specialized clinical expertise.
Purpose: The purpose of this study is to determine whether a telepsychiatry-based collaborative program is effective to improve the management of depression in adolescents between 13 and 19 years of age in 16 primary care clinics in the Araucanía Region, Chile.
Study design: A cluster-randomized clinical trial will be carried out with 237 adolescents. The efficacy, adherence, and acceptability of the telepsychiatry-based collaborative program will be evaluated.
Read the detailed description
General aim To carry out a randomized controlled trial to compare the efficacy of telepsychiatry intervention versus usual care to treat depression in adolescents in primary care clinics in the Araucanía Region, Chile.
Specific aims
- To compare the level of depressive symptoms of adolescents suffering depression participating in a telepsychiatry program versus usual care in primary care clinics.
- To compare the level of health-related quality of life (HRQoL) of adolescents suffering depression participating in a telepsychiatry program versus usual care in primary care clinics.
- To compare adolescents' adherence with a telepsychiatry program versus usual care in primary care clinics.
- To evaluate adolescents' satisfaction with a telepsychiatry program.
- To evaluate health staff's satisfaction with a telepsychiatry program.
- Conditions
- Depression
- Being tested
- Telepsychiatry collaborative program, Usual care
- Keywords
- depression, adolescents
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telepsychiatry collaborative programOther
The intervention includes:
- Online training for the health staff
- Medical and psychological treatment, as described in the AUGE Clinical Guidelines for Depression
- Online supervision in a web platform by specialists
- Telephone monitoring
Usual careOther
- Online training for the health staff
- Medical and psychological treatment, as described in the AUGE Clinical Guidelines for Depression
| Study group | Role | What they receive |
|---|---|---|
| Telepsychiatry collaborative program | Experimental | * Online training on the diagnosis and management of adolescent depression for health professionals from primary care clinics participating in active branch.
* Clinical management of depression by primary care professionals, according to algorithms based on the Clinical Guidelines of the Chilean Ministry of Health (MINSAL).
* Supervision of primary care professionals through an internet site run by a team of specialists.
* Telephone monitoring of patients by personnel trained on clinical progress, treatment adherence, and side effects (applicable for patients taking drugs). Receives: Other: Telepsychiatry collaborative program |
| Usual care | Active comparator | * Online training on the diagnosis and management of adolescent depression for health professionals from primary care centers participating in active branch.
* Clinical management of depression by primary care professionals, according to algorithms based on the Clinical Guidelines of the Chilean Ministry of Health (MINSAL). Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Beck Depression Inventory (BDI)
Measured: Baseline and 12 weeks
Secondary outcomes (1)
Change from baseline in KIDSCREEN-27
Health-related quality of life questionnaire
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2016
- Study completionFeb 2016
Why it stopped: Because there are enough data to present the conclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vania Martínez-Nahuel, University of Chile
- Investigators
- Vania Martínez-Nahuel, Dr.med., Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860443
- Sponsor's protocol ID
- FONIS SA12I1294
- Status last verified
- May 2016
- First submitted
- 18 May 2013
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Martinez V, Rojas G, Martinez P, Zitko P, Irarrazaval M, Luttges C, Araya R. Remote Collaborative Depression Care Program for Adolescents in Araucania Region, Chile: Randomized Controlled Trial. J Med Internet Res. 2018 Jan 31;20(1):e38. doi: 10.2196/jmir.8021.
PubMed 29386172
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telepsychiatry-Based Collaborative Program to Improve the Management of Adolescent Depression in Primary Care Clinics in the Araucanía Region, Chile: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01860443
- Acronym / sponsor ID
- FONIS SA12I1294
- Conditions
- Depression
- Keywords
- depression, adolescents
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because there are enough data to present the conclusions
- Enrolment
- 143 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 22 May 2013 (estimated)
- 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 common in adolescents and it is associated with serious consequences. In Chile, primary care team has a leading role in the management of depression in adolescents. Nevertheless, the majority of primary care professionals report not feeling adequately prepared to take on this responsibility and having difficulties referring patients to specialists. This situation is particularity complex in regions far away from the central zone. Telepsychiatry is a potential solution to an equitable access to specialized clinical expertise.
Purpose: The purpose of this study is to determine whether a telepsychiatry-based collaborative program is effective to improve the management of depression in adolescents between 13 and 19 years of age in 16 primary care clinics in the Araucanía Region, Chile.
Study design: A cluster-randomized clinical trial will be carried out with 237 adolescents. The efficacy, adherence, and acceptability of the telepsychiatry-based collaborative program will be evaluated.
Detailed description
General aim To carry out a randomized controlled trial to compare the efficacy of telepsychiatry intervention versus usual care to treat depression in adolescents in primary care clinics in the Araucanía Region, Chile.
Specific aims
- To compare the level of depressive symptoms of adolescents suffering depression participating in a telepsychiatry program versus usual care in primary care clinics.
- To compare the level of health-related quality of life (HRQoL) of adolescents suffering depression participating in a telepsychiatry program versus usual care in primary care clinics.
- To compare adolescents' adherence with a telepsychiatry program versus usual care in primary care clinics.
- To evaluate adolescents' satisfaction with a telepsychiatry program.
- To evaluate health staff's satisfaction with a telepsychiatry program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telepsychiatry collaborative program | Experimental | Other: Telepsychiatry collaborative program* Online training on the diagnosis and management of adolescent depression for health professionals from primary care clinics participating in active branch. * Clinical management of depression by primary care professionals, according to algorithms based on the Clinical Guidelines of the Chilean Ministry of Health (MINSAL). * Supervision of primary care professionals through an internet site run by a team of specialists. * Telephone monitoring of patients by personnel trained on clinical progress, treatment adherence, and side effects (applicable for patients taking drugs). |
| Usual care | Active comparator | Other: Usual care* Online training on the diagnosis and management of adolescent depression for health professionals from primary care centers participating in active branch. * Clinical management of depression by primary care professionals, according to algorithms based on the Clinical Guidelines of the Chilean Ministry of Health (MINSAL). |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Meets diagnostic criteria of a depressive disorder according a structured interview (MINI-KID)
Key exclusion criteria (6 listed)
- Psychotic symptoms
- Bipolar disorder
- Current substance and/or alcohol dependence
- Suicide risk that requires specialized treatment
- Current treatment with antidepressant and/or 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 |
|---|---|---|
| Telepsychiatry collaborative programThe intervention includes: * Online training for the health staff * Medical and psychological treatment, as described in the AUGE Clinical Guidelines for Depression * Online supervision in a web platform by specialists * Telephone monitoring | Other | Telepsychiatry collaborative program |
| Usual care* Online training for the health staff * Medical and psychological treatment, as described in the AUGE Clinical Guidelines for Depression | Other | Usual care |
Primary outcome
Change from baseline in Beck Depression Inventory (BDI)
Time frame: Baseline and 12 weeks
1 secondary outcome
Change from baseline in KIDSCREEN-27
Time frame: Baseline and 12 weeks
Results and safety
The study was stopped early (reason given: Because there are enough data to present the conclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
- Derived from this study: PubMed 29386172Martinez V, Rojas G, Martinez P, Zitko P, Irarrazaval M, Luttges C, Araya R. Remote Collaborative Depression Care Program for Adolescents in Araucania Region, Chile: Randomized Controlled Trial. J Med Internet Res. 2018 Jan 31;20(1):e38. doi: 10.2196/jmir.8021.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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 Martínez-Nahuel, Dr.med. principal investigator
University of Chile
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telepsychiatry collaborative program in people with Depression, run by University of Chile at 7 sites 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 1 inclusion and 6 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: stopped early, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 was stopped early (reason given: Because there are enough data to present the conclusions). 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 in Beck Depression Inventory (BDI) (time frame: Baseline and 12 weeks). 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 NCT01860443, which also lists 1 linked publication.
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 17 May 2016.