ClinicalTrials.gov
ClinicalTrials.gov Menu

Telepsychiatry to Improve the Management of Adolescent Depression in Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01860443
Recruitment Status : Terminated (Because there are enough data to present the conclusions)
First Posted : May 22, 2013
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
Vania Martínez-Nahuel, University of Chile

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Depression Other: Telepsychiatry collaborative program Other: Usual care Not Applicable

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

  1. To compare the level of depressive symptoms of adolescents suffering depression participating in a telepsychiatry program versus usual care in primary care clinics.
  2. 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.
  3. To compare adolescents' adherence with a telepsychiatry program versus usual care in primary care clinics.
  4. To evaluate adolescents' satisfaction with a telepsychiatry program.
  5. To evaluate health staff's satisfaction with a telepsychiatry program.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : June 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
Other: Telepsychiatry collaborative program

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

Active Comparator: 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).
Other: Usual care
  • Online training for the health staff
  • Medical and psychological treatment, as described in the AUGE Clinical Guidelines for Depression




Primary Outcome Measures :
  1. Change from baseline in Beck Depression Inventory (BDI) [ Time Frame: Baseline and 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in KIDSCREEN-27 [ Time Frame: Baseline and 12 weeks ]
    Health-related quality of life questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860443


Locations
Chile
CESFAM Alemania, CESFAM Huequén, CESFAM Piedra de Águila
Angol, Chile
CESFAM Dr. Cristóbal Sáenz Cerda
Lautaro, Chile
CESFAM Nueva Imperial
Nueva Imperial, Chile
Consultorio Pitrufquén
Pitrufquén, Chile
CESFAM Amanecer, CESFAM Labranza, CESFAM Pedro de Valdivia, CESFAM Pueblo Nuevo, CESFAM Santa Rosa, CESFAM Villa Alegre, Consultorio Miraflores
Temuco, Chile
Hospital de Vilcún
Vilcún, Chile
CESFAM Villarrica
Villarrica, Chile
Sponsors and Collaborators
University of Chile
Investigators
Principal Investigator: Vania Martínez-Nahuel, Dr.med. University of Chile

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vania Martínez-Nahuel, Dr.med., University of Chile
ClinicalTrials.gov Identifier: NCT01860443     History of Changes
Other Study ID Numbers: FONIS SA12I1294
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016

Keywords provided by Vania Martínez-Nahuel, University of Chile:
depression
adolescents

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders