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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

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Detailed Description:

The prevalence of chronic non-communicable diseases, including cardiovascular disease (CVD), type-2 diabetes (DM), and common mental disorders (CMD), i.e. anxiety & depression, are increasing worldwide, including in India, where patients with CMD are underserved, especially in rural areas, due to both stigma and lack of trained providers.

Treatment of patients with dual diagnoses involves special challenges and, if left untreated, mental illness can contribute to non-adherence and worsened outcomes.

Similarly, lack of staff training in India's Primary Health Centers (PHC) can result in missed diagnoses, inappropriate treatment, and increased morbidity and suffering. A growing body of research suggests that some of these challenges can be overcome by integrating treatment of patients with co-morbid diagnoses, by using "stepped" or "collaborative" care models. Such integration may also help reduce the stigma of seeking mental health services.

We plan to address this need by implementing and evaluating a multi-level integrated intervention in collaboration with 50 Primary Health Clinics (PHC) in rural Karnataka using a cluster Randomized Controlled Trial (cRCT). Our approach is based on our team's previous clinical and behavioral research in this region and builds on a decade long collaboration between St. John's Research Institute and University of California San Francisco. This study brings together an Indo-US team of scientists and government representatives with expertise in treating and studying mental health, chronic diseases, behavior change, stigma, and in conducting large clinical trials in rural India. It also builds on the work by India's National Rural Health Mission (NRHM), which recently announced that it will add tobacco control to its agenda. If successful, this intervention thus has high potential for scale-up and sustainability.

The proposed intervention is informed by a Social Ecological Paradigm that articulates the relationship between social settings and health behavior. It uses behavior change strategies guided by Cognitive Social Theory. Patients in intervention PHCs 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. These groups will initially be co-facilitated by a Master's level mental health professional and a trained lay community health outreach worker (ASHA) on a weekly basis for 3 months. During the remaining 9 months, the ASHA will conduct monthly booster sessions focusing on the maintenance of the acquired health-promoting behaviors. Patients in control PHCs will receive an "enhanced standard" care model, which includes providing referrals for mental health needs.

To ensure standardization of study procedures across settings, all control PHC staff will receive basic training in established clinical protocols, plus training in the prescription of anti-depressant medication. While this may represent somewhat of an intervention, we did not consider it ethical to allow clinically depressed patients to be treated with vitamins and anxiolytics, which are currently frequently used in the PHC.

Following a brief start-up phase to adapt measures and finalize protocols, we propose to:

  1. Use ASHAs to conduct community-based screening of depression, anxiety, DM and CVD risk factors during community health fairs in the catchment areas of 25 PHCs to examine a) whether this increases subsequent diagnoses in the PHC of patients with co-morbid mental health and chronic disease diagnoses and b) whether such patients are as likely to enter and remain in treatment, compared to the standard PHC-based screening.
  2. Implement and evaluate the effects of providing staff training in the collaborative care model of integrated mental health (depression, anxiety) and cardiovascular disease (hypertension, diabetes, CVD) to intervention PHC staff and compare them to control PHC staff with respect to a) knowledge and clinical skills using clinical patient vignettes, and b) perceived satisfaction reported by clinic patients in intervention and control PHCs.
  3. Implement and evaluate the effects of our, multi-level integrated clinic and community-based intervention for co-morbid primary care patients compared to the enhanced standard non-integrated treatment services in a cRCT with 50 participating PHC, with regard to both mental health (depression and anxiety) and physical health (diabetes and cardiovascular disease) outcomes at post intervention, 6 month and 12 month follow up.

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

U.S. FDA Resources

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, Senior)
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