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E-mental Health Support for Rural Areas

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
e-mental health collaborative programme
Usual Care
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Primary health care, Computer communication network, Depression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    e-mental health collaborative programme

    Usual Care

    Arm Description

    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.

    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

    Outcomes

    Primary Outcome Measures

    Depressive Symptoms change after baseline

    Secondary Outcome Measures

    Quality of Life change after baseline

    Full Information

    First Posted
    July 15, 2014
    Last Updated
    July 23, 2014
    Sponsor
    University of Chile
    Collaborators
    Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02200367
    Brief Title
    E-mental Health Support for Rural Areas
    Official Title
    AN e- MENTAL HEALTH COLLABORATIVE PROGRAMME TO DEPRESSION MANAGEMENT IN RURAL PRIMARY CARE IN CHILE:A PILOT CLINICAL STUDY.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    February 2013 (Actual)
    Study Completion Date
    March 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Chile
    Collaborators
    Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression
    Keywords
    Primary health care, Computer communication network, Depression

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    254 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    e-mental health collaborative programme
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Usual Care
    Arm Type
    Other
    Arm Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    e-mental health collaborative programme
    Intervention Type
    Other
    Intervention Name(s)
    Usual Care
    Primary Outcome Measure Information:
    Title
    Depressive Symptoms change after baseline
    Time Frame
    three and six months
    Secondary Outcome Measure Information:
    Title
    Quality of Life change after baseline
    Time Frame
    three and six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29712627
    Citation
    Rojas G, Guajardo V, Martinez P, Castro A, Fritsch R, Moessner M, Bauer S. A Remote Collaborative Care Program for Patients with Depression Living in Rural Areas: Open-Label Trial. J Med Internet Res. 2018 Apr 30;20(4):e158. doi: 10.2196/jmir.8803.
    Results Reference
    derived

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