Training and Supervision Program for Depression Management
NCT ID: NCT02232854
Last Updated: 2017-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
256 participants
INTERVENTIONAL
2014-04-30
2016-06-30
Brief Summary
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Detailed Description
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The sample selection of the PHC clinics will be performed in two steps. Firstly, two urban municipalities of Santiago Metropolitan Region, Chile, will be randomly selected if they work with the Faculty of Medicine of the U.Chile and have at least two PHC.Municipalities with a high Human Development Index, high percentage of immigrants and older population, and Psychiatry residents working in PHC , will be excluded.Secondly in each selected municipalities,two PHC will be randomly selected for the active and control arm.
To detect a difference of 20%, in a one-sided model, with an alpha of 5% and power of 80%, 152 depressed persons, 76 to each group, will be required for the study. A design effect of 2.42 was estimated. After applying the design effect the sample needed increased to 368 depressed persons. Considering a retention rate of approximately 85%, 434 depressed cases will be needed required for the study, hence 109 cases in each of the 4 primary health care clinics.
Analysis and presentation of the results will be in accordance with CONSORT guidelines for randomized clinical trials, with the primary comparative analysis being conducted on an intention to treat basis and due emphasis placed on confidence intervals for the between-arm comparisons.
Initially descriptive analysis to assess the balance between two groups will be conducted. The primary analysis will employ multilevel multivariable lineal regression to investigate differences in the PHQ-9 scores between groups at 3 and 6 months after randomization, adjusting for baseline outcome variable scores. Sensitivity analysis making different assumptions will be conducted to investigate the potential effects of missing data. Similar analysis will be done for the secondary outcomes measures.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Depression training/supervision program
A complex intervention, which will include:
* Primary Health Care team training in depression
* A focus group, after training
* Telephone monitoring of patients
* Web-based supervision of clinicians
Depression training/supervision program
The intervention will be composed of:
* Training of Primary Health Care teams to ensure compliance to the "Clinical Guidelines of the Ministry of Health for the Treatment of Depression". Primary Health Care teams will undergo an Objective Structured Clinical Examination (OSCE) for evaluation.
* After the training, a focus group between Primary Health Care teams and study researchers will be held in order to address barriers to clinical guidelines implementation.
* Primary Health Care clinics' trained administrative staff will contact patients from a call-center to support treatment adherence.
* Psychiatrists, using a web-based platform, will supervise the course of the program, the allocated treatments, the patients' progress, and their response to treatment.
Usual Care
Patients in the control group will receive all the interventions that are guaranteed for persons with depression in Chile: treatment in Primary Health Care clinics with the Primary Health Care team and referral to the regional specialized psychiatric service.
No interventions assigned to this group
Interventions
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Depression training/supervision program
The intervention will be composed of:
* Training of Primary Health Care teams to ensure compliance to the "Clinical Guidelines of the Ministry of Health for the Treatment of Depression". Primary Health Care teams will undergo an Objective Structured Clinical Examination (OSCE) for evaluation.
* After the training, a focus group between Primary Health Care teams and study researchers will be held in order to address barriers to clinical guidelines implementation.
* Primary Health Care clinics' trained administrative staff will contact patients from a call-center to support treatment adherence.
* Psychiatrists, using a web-based platform, will supervise the course of the program, the allocated treatments, the patients' progress, and their response to treatment.
Eligibility Criteria
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Inclusion Criteria
* age between 18-65 years
* current depressive episode, according to the Mini-International Neuropsychiatric Interview (MINI)
Exclusion Criteria
* no access to telephone
18 Years
65 Years
ALL
No
Sponsors
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University of Chile
OTHER
Responsible Party
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Graciela Rojas Castillo
Dr.med. Psychyatrist
Locations
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CESFAM Garín
Quinta Normal, Santiago Metropolitan, Chile
CESFAM Lo Franco
Quinta Normal, Santiago Metropolitan, Chile
CESFAM Barros Luco
San Miguel, Santiago Metropolitan, Chile
CESFAM Recreo
San Miguel, Santiago Metropolitan, Chile
Countries
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References
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Rojas G, Martinez P, Vohringer PA, Martinez V, Castro-Lara A, Fritsch R. Comprehensive technology-assisted training and supervision program to enhance depression management in primary care in Santiago, Chile: study protocol for a cluster randomized controlled trial. Trials. 2015 Jul 24;16:311. doi: 10.1186/s13063-015-0845-4.
Other Identifiers
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1130230
Identifier Type: -
Identifier Source: org_study_id