- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01860443
Telepsychiatry to Improve the Management of Adolescent Depression in Primary Care
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Angol, Chile
- CESFAM Alemania, CESFAM Huequén, CESFAM Piedra de Águila
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Lautaro, Chile
- CESFAM Dr. Cristóbal Sáenz Cerda
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Nueva Imperial, Chile
- CESFAM Nueva Imperial
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Pitrufquén, Chile
- Consultorio Pitrufquén
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Temuco, Chile
- CESFAM Amanecer, CESFAM Labranza, CESFAM Pedro de Valdivia, CESFAM Pueblo Nuevo, CESFAM Santa Rosa, CESFAM Villa Alegre, Consultorio Miraflores
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Vilcún, Chile
- Hospital de Vilcún
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Villarrica, Chile
- CESFAM Villarrica
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Meets diagnostic criteria of a depressive disorder according a structured interview (MINI-KID)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Telepsychiatry collaborative program
|
The intervention includes:
|
Active Comparator: Usual care
|
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in Beck Depression Inventory (BDI)
Time Frame: Baseline and 12 weeks
|
Baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in KIDSCREEN-27
Time Frame: Baseline and 12 weeks
|
Health-related quality of life questionnaire
|
Baseline and 12 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FONIS SA12I1294
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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