- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02232854
Training and Supervision Program for Depression Management
Comprehensive Technology-Assisted Training and Supervision Program to Enhance Depression Management in Primary Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A cluster randomized controlled clinical trial will be conducted in four Primary Health Care (PHC) clinics in Santiago, Chile.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Santiago
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Quinta Normal, Santiago, Chile
- CESFAM Garín
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Quinta Normal, Santiago, Chile
- CESFAM Lo Franco
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San Miguel, Santiago, Chile
- CESFAM Barros Luco
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San Miguel, Santiago, Chile
- CESFAM Recreo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- signing written informed consent
- age between 18-65 years
- current depressive episode, according to the Mini-International Neuropsychiatric Interview (MINI)
Exclusion Criteria:
- current depression treatment
- no access to telephone
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Depression training/supervision program
A complex intervention, which will include:
|
The intervention will be composed of:
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No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Depressive Symptomatology at 3 months
Time Frame: Baseline , 3 months
|
Depressive symptomatology measured with the Patient Health Questionnaire - Nine Item (PHQ-9) at 3 months after patient recruitment.
|
Baseline , 3 months
|
Change from Baseline Depressive Symptomatology at 6 months
Time Frame: Baseline, 6 months.
|
Depressive symptomatology measured with the Patient Health Questionnaire - Nine Item (PHQ-9) at 6 months after patient recruitment.
|
Baseline, 6 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to depression treatment at patient's level
Time Frame: 3 and 6 months after baseline.
|
3 and 6 months after baseline.
|
|
Change from Baseline Quality of life at 3 and 6 months
Time Frame: Baseline , 3 months, 6 months.
|
Quality of life at patient's level measured with the Health Survey, Short form (SF-36), at 3 months and 6 months after patient recruitment.
|
Baseline , 3 months, 6 months.
|
Change from Baseline Clinical Outcomes at 3 and 6 months
Time Frame: Baseline , 3 months, 6 months.
|
Clinical outcomes at patient's level measured with the Outcome Questionnaire-45.2 (OQ-45.2),
at 3 months and 6 months after patient recruitment.
|
Baseline , 3 months, 6 months.
|
Use of Health Care services at patient's level
Time Frame: 3 and 6 months after baseline
|
Use of Health Care services at patient's level measured with and ad-hoc built questionnaire.
|
3 and 6 months after baseline
|
Rate of treated depressed cases at Primary Care team level
Time Frame: 12 months before randomization and 12 months after.
|
12 months before randomization and 12 months after.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1130230
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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