Evaluating the Benefits and Affordability of a Program to Improve the Care of Common Mental Disorders in Primary Care - Full Text View

Sponsors and Collaborators:	London School of Hygiene and Tropical Medicine Wellcome Trust Sangath Voluntary Health Association of Goa, India Government of Goa, India
Information provided by:	London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:	NCT00446407

Purpose

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
Depressive Disorders Anxiety Disorders Depression	Other: Collaborative Stepped Care Intervention Other: Enhanced Usual Care

MedlinePlus related topics: Anxiety Depression Mental Health

Drug Information available for: Fluoxetine Fluoxetine hydrochloride

U.S. FDA Resources

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

Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:

Recovery from Common Mental Disorder (defined by ICD10) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Case of CMD among all screen-positive participants at 2, 6 and 12 months [ Time Frame: 2, 6 and 12 months ] [ Designated as safety issue: No ]
Case of CMD among all sub-threshold cases [ Time Frame: at 2, 6 and 12 months ] [ Designated as safety issue: No ]
Recovery from CMD (defined by ICD10) among the subgroup with ICD-10 Depression at baseline [ Time Frame: at 2, 6 and 12 months ] [ Designated as safety issue: No ]
Psychological morbidity (mean scores) [ Time Frame: at 2, 6 and 12 months ] [ Designated as safety issue: No ]
Disability levels [ Time Frame: at 2, 6 and 12 months ] [ Designated as safety issue: No ]
Costs of illness [ Time Frame: 2, 6 and 12 months ] [ Designated as safety issue: No ]

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
Collaborative Stepped Care: Experimental Screening, Antidepressants, Psychosocial interventions (psychoeducation, IPT, adherence management) by Health Counselor, support and supervision by Psychiatrist.	Other: Collaborative Stepped Care Intervention Psychoeducation, interpersonal therapy, fluoxetine (20-40 mg/d), adherence management
Enhanced Usual Care: Active Comparator	Other: Enhanced Usual Care Screening plus Antidepressants based on practice guidelines

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age above 18;
Suffering from a Common Mental Disorder (as defined by an a priori cut-off score on the 12 item General Health Questionnaire)
Resident in the state (Goa) for the subsequent 12 months
Not requiring urgent medical/surgical attention (e.g hospital admission)

Exclusion Criteria:

Suffering from a cognitive or sensory impairment which makes participation in the evaluation difficult
Not speaking Konkani, Marathi, Hindi or English

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446407

Contacts

Contact: Sulochana Pednekar	+91-832-2414916	sulochana@sangath.com
Contact: Vikram Patel	+91-9822132038	vikram.patel@lshtm.ac.uk

Locations

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

Sponsors and Collaborators

London School of Hygiene and Tropical Medicine

Wellcome Trust

Sangath

Voluntary Health Association of Goa, India

Government of Goa, India

Investigators

Principal Investigator:

Vikram Patel

London School of Hygiene & Tropical Medicine

More Information

Link to primary UK academic institution leading the trial This link exits the ClinicalTrials.gov site

Link to primary Indian organization leading the trial This link exits the ClinicalTrials.gov site

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
Health Authority:	India: Institutional Review Board

Keywords provided by London School of Hygiene and Tropical Medicine:

Depression
Primary Care
Developing Countries
Common mental disorders (depressive and anxiety disorders)

Study placed in the following topic categories:

Fluoxetine
Depression
Anxiety Disorders
Mental Disorders

Mood Disorders
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009