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Improving Mental Health Through Integration With Primary Care in Rural Karnataka

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ClinicalTrials.gov Identifier: NCT02310932
Recruitment Status : Recruiting
First Posted : December 8, 2014
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This cluster Randomized Controlled Trial was designed to implement and evaluate the effects of a multi-level intervention designed to integrate mental health treatment into rural primary health clinics in South India using a collaborative care model.

Condition or disease Intervention/treatment Phase
Chronic Disease Depression Anxiety Behavioral: Healthy Living Intervention Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Improving Mental Health Through Integration With Primary Care in Rural Karnataka
Study Start Date : February 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy Living Intervention
The Healthy Living Intervention group will participate in an intervention designed to improve depression, anxiety, diabetes and CVD outcomes. This will be achieved through a 12 month intervention which consists of participation in healthy living groups and integrated collaborative clinic care at their Primary Health Clinic (PHC).
Behavioral: Healthy Living Intervention
Patients in the intervention groups will receive integrated collaborative clinic care by their physicians, a nurse case manager and consulting psychiatrists. They will also participate in 12-month community-based "Healthy Living groups," in which cognitive and behavioral strategies are used to target health promoting behaviors, such as increased activity, improved diet, adherence to medical regimens, as well as problem-solving skills, coping skills, and social support.

Placebo Comparator: Enhanced Standard Care Model
Patients in control groups will receive an "enhanced standard" care model, which includes providing referrals for mental health needs.
Behavioral: Healthy Living Intervention
Patients in the intervention groups will receive integrated collaborative clinic care by their physicians, a nurse case manager and consulting psychiatrists. They will also participate in 12-month community-based "Healthy Living groups," in which cognitive and behavioral strategies are used to target health promoting behaviors, such as increased activity, improved diet, adherence to medical regimens, as well as problem-solving skills, coping skills, and social support.




Primary Outcome Measures :
  1. incidence of dually diagnosed participants [ Time Frame: 1 year ]
    incidence of patients presenting to Primary Health Clinic (PHC) with a dual diagnosis of depression or anxiety, and diabetes or cardiovascular disease in in the standard versus enhanced screening arms.

  2. anxiety or depression [ Time Frame: 1 year ]
    levels of anxiety or depression reported by participants, depending on initial diagnosis

  3. blood glucose control [ Time Frame: 1 year ]
    for patients presenting with diabetes

  4. blood pressure [ Time Frame: 1 year ]
    for patients presenting with hypertension

  5. cholesterol [ Time Frame: 1 year ]
    for patients presenting with hypercholesterolemia


Secondary Outcome Measures :
  1. medication adherence [ Time Frame: 1 year ]
    adherence to medical regimen using a Visual Analog scale. Specific regimen depends on initial diagnosis



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 30 years or older;
  • Diagnosed with co-morbid CMD (Depression or Anxiety Disorder) and either
  • Able and willing to consent and participate in the intervention and all assessments;
  • Able to speak Kannada; and
  • Mentally competent to provide consent and answer to study measures and participate in intervention (MMSE score greater than 26).

Exclusion Criteria:

  • Under 30 years of age;
  • Patients who are not diagnosed with co-morbid CMD (Depression or Anxiety Disorder) and either hypertension, diabetes, or diagnosed ischemic heart disease;
  • Not mentally competent to provide consent and answer to study measures and participate in intervention (MMSE score > 26).
  • Unable to speak Kannada; and
  • Participants who do not provide contact information.

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): NCT02310932


Contacts
Contact: Krishnamachari Srinivasan, MD srinivasanstjohns@gmail.com

Locations
India
St. John & Research Institute/St John & Medical College & Hospital Recruiting
Bangalore, Karnataka, India, 560 034
Contact: Priya Shetty, MPH       priyashetty@sjri.res.in   
Principal Investigator: Krishnamachari Srinivasan,, MD         
Sub-Investigator: Prem Mony, MD         
Sponsors and Collaborators
University of California, San Francisco
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Maria L Ekstrand, MD University of California, San Francisco

Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02310932     History of Changes
Other Study ID Numbers: R01MH100311 ( U.S. NIH Grant/Contract )
R01MH100311 ( U.S. NIH Grant/Contract )
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

Keywords provided by University of California, San Francisco:
mental health
cardiovascular disease
diabetes
hypertension
high blood pressure

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes