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E-mental Health Support for Rural Areas

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. Identifier: NCT02200367
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : July 25, 2014
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Information provided by (Responsible Party):
Graciela Rojas Castillo, University of Chile

Brief Summary:

In the treatment of depression, primary care team play an important role, but they are most effective when inserted into a collaborative model of disease management.

Hypotheses:Depressed patients treated in rural primary care clinics participating in a e-mental heath collaborative programme to manage depression achieve at least 20% better recovery rates in comparison with the control group three months after the baseline assessment.

Goal: to compare the effectiveness of a e-mental health collaborative programme with usual care in rural primary-care clinics.

Methodology: a clinical trial with two arms will be conducted in 13 community rural hospitals in Chile. The active group will participate in a collaborative programme between primary care teams and specialized teams, with support from an electronic platform and a call center.The control group will receive usual care, according to the Ministry of Health's Guidelines to Depression.To evaluate inclusion criteria -depressive patients aged between 18 and 70 years- and exclusion criteria -current in treatment for depression- an interview will be used that will include the Mini-International Neuropsychiatric Interview (MINI) to evaluate depression .The principal outcome will be depressive symptoms measured with the Beck Depression Inventory (BDI-I), and secondary outcome quality of life measured with the Health Survey (SF-36) at three and six months after baseline assessment.To detect a difference of 20%, in a one-sided model, with an alpha of 5% and power of 80%, would require 152 depressed persons (76 to intervention and 76 to control group).A design effect of 1.35 based on an Intraclass Coefficient Correlation (ICC) of 0,03839 and 13 clinics were considered. After applying the design effect the sample needed increased to 206 depressed persons. Considering a retention rate of approximately 85% 237 depressed cases will be needed.

A program of this kind may be useful to assist primary care teams in remote areas of the country, in order to improve treatment outcomes for depression that is currently addressed at the primary care level.

Condition or disease Intervention/treatment Phase
Depression Behavioral: e-mental health collaborative programme Other: Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: e-mental health collaborative programme
It is a complex intervention to support primary care providers of rural primary care service to manage depressed patients. Primary care providers at the intervention sites were supported by psychiatrist using an electronic platform.Patients were monitored through a call center.
Behavioral: e-mental health collaborative programme
Usual Care
Patients in this arm received all the interventions that are guaranteed for the persons with depression in Chile: treatment in the primary clinics with the primary care team and referral to the regional specialized psychiatric service
Other: Usual Care

Primary Outcome Measures :
  1. Depressive Symptoms change after baseline [ Time Frame: three and six months ]

Secondary Outcome Measures :
  1. Quality of Life change after baseline [ Time Frame: three and six months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects aged 18 or more with a current major depressive episode according to Diagnostic and Statistical Manual of Mental Disorders IV criteria (DSM-IV)

Exclusion Criteria:

  • Depressive treatment currently in process.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Graciela Rojas Castillo, Psychyatrist, University of Chile Identifier: NCT02200367    
Other Study ID Numbers: 1100205
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: July 25, 2014
Last Verified: July 2014
Keywords provided by Graciela Rojas Castillo, University of Chile:
Primary health care
Computer communication network
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders