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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00446407
First Posted: March 12, 2007
Last Update Posted: April 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Wellcome Trust
Sangath
Voluntary Health Association of Goa, India
Government of Goa, India
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine
  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
Intervention Model: Parallel Assignment
Masking: Single (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:


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 ]

Secondary Outcome Measures:
  • Case of CMD among all screen-positive participants at 2, 6 and 12 months [ Time Frame: 2, 6 and 12 months ]
  • Case of CMD among all sub-threshold cases [ Time Frame: at 2, 6 and 12 months ]
  • Recovery from CMD (defined by ICD10) among the subgroup with ICD-10 Depression at baseline [ Time Frame: at 2, 6 and 12 months ]
  • Psychological morbidity (mean scores) [ Time Frame: at 2, 6 and 12 months ]
  • Disability levels [ Time Frame: at 2, 6 and 12 months ]
  • Costs of illness [ Time Frame: 2, 6 and 12 months ]

Enrollment: 2796
Study Start Date: April 2007
Study Completion Date: February 2010
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00446407     History of Changes
Other Study ID Numbers: MANAS
First Submitted: March 9, 2007
First Posted: March 12, 2007
Last Update Posted: April 1, 2015
Last Verified: July 2009

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:
Disease
Depression
Depressive Disorder
Anxiety Disorders
Mental Disorders
Psychotic Disorders
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Schizophrenia Spectrum and Other Psychotic Disorders