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Evaluating the Benefits and Affordability of a Program to Improve the Care of Common Mental Disorders in Primary Care (MANAS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by London School of Hygiene and Tropical Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
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
First received: March 9, 2007
Last updated: August 3, 2009
Last verified: July 2009
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Collaborative Stepped Care
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
Active Comparator: Enhanced Usual Care 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

Locations
India
Sangath
Porvorim, Goa, India, 403521
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 and Tropical Medicine
  More Information

Additional 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

No publications provided by London School of Hygiene and Tropical Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Vikram Patel, London School of Hygiene & Tropical Medicine
ClinicalTrials.gov Identifier: NCT00446407     History of Changes
Other Study ID Numbers: MANAS
Study First Received: March 9, 2007
Last Updated: August 3, 2009
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)

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Psychotic Disorders
Depression
Depressive Disorder
Schizophrenia and Disorders with Psychotic Features
Behavioral Symptoms
 Mood Disorders
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013