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Sponsors and Collaborators: |
London School of Hygiene and Tropical Medicine Wellcome Trust Sangath Voluntary Health Association of Goa, India Government of Goa, India |
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Information provided by: | London School of Hygiene and Tropical Medicine |
ClinicalTrials.gov Identifier: | NCT00446407 |
Depressive and anxiety disorders (termed as 'Common Mental Disorders') affect as many as one in four persons attending primary care; most patients do not receive effective treatments. Although the integration of mental health in primary care is accepted as the only feasible way of managing Common Mental Disorders in developing countries, there is no evidence demonstrating how this can be done in a manner which is effective and affordable. The hypothesis of this trial is that a Collaborative Stepped Care package will be both clinically and cost-effective for the treatment of Common Mental Disorders in primary care.
Condition | Intervention |
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Depressive Disorders Anxiety Disorders Depression |
Other: Collaborative Stepped Care Intervention Other: Enhanced Usual Care |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | The Effectiveness and Cost-Effectiveness of a Collaborative Stepped Care Intervention for the Treatment of Common Mental Disorders in Primary Care Settings in Goa, India |
Estimated Enrollment: | 2400 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Collaborative Stepped Care: Experimental
Screening, Antidepressants, Psychosocial interventions (psychoeducation, IPT, adherence management) by Health Counselor, support and supervision by Psychiatrist.
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Other: Collaborative Stepped Care Intervention
Psychoeducation, interpersonal therapy, fluoxetine (20-40 mg/d), adherence management
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Enhanced Usual Care: Active Comparator |
Other: Enhanced Usual Care
Screening plus Antidepressants based on practice guidelines
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sulochana Pednekar | +91-832-2414916 | sulochana@sangath.com |
Contact: Vikram Patel | +91-9822132038 | vikram.patel@lshtm.ac.uk |
India, Goa | |
Sangath | Recruiting |
Porvorim, Goa, India, 403521 | |
Contact: Sulochana Pednekar +91-832-2414916 sulochana@sangath.com | |
Contact: Vikram Patel +91-9822132038 vikram.patel@lshtm.ac.uk | |
Sub-Investigator: Sulochana Pednkear |
Principal Investigator: | Vikram Patel | London School of Hygiene & Tropical Medicine |
Responsible Party: | London School of Hygiene & Tropical Medicine ( Vikram Patel ) |
Study ID Numbers: | MANAS |
Study First Received: | March 9, 2007 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00446407 History of Changes |
Health Authority: | India: Institutional Review Board |
Depression Primary Care Developing Countries Common mental disorders (depressive and anxiety disorders) |
Fluoxetine Depression Anxiety Disorders Mental Disorders |
Mood Disorders Depressive Disorder Antidepressive Agents Behavioral Symptoms |
Pathologic Processes Disease Depression Anxiety Disorders |
Mental Disorders Mood Disorders Depressive Disorder Behavioral Symptoms |