E-mental Health Support for Rural Areas

Depression Clinical Trial

Official title:

AN e- MENTAL HEALTH COLLABORATIVE PROGRAMME TO DEPRESSION MANAGEMENT IN RURAL PRIMARY CARE IN CHILE:A PILOT CLINICAL STUDY.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02200367
• Other study ID #: 1100205
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: March 2013

Study information

• Verified date: December 2023
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• e-mental health collaborative programme

Other:
• Usual Care

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Chile	Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive Symptoms change after baseline	BDI-I	three and six months
Secondary	Quality of Life change after baseline	SF-36	three and six months