Improving Mental Health Through Integration With Primary Care in Rural Karnataka

June 4, 2020 updated by: University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

2507

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560 034
        • St. John & Research Institute/St John & Medical College & Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
anxiety or depression
Time Frame: 1 year
levels of anxiety or depression reported by participants, depending on initial diagnosis
1 year
blood glucose control
Time Frame: 1 year
for patients presenting with diabetes
1 year
blood pressure
Time Frame: 1 year
for patients presenting with hypertension
1 year
cholesterol
Time Frame: 1 year
for patients presenting with hypercholesterolemia
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
medication adherence
Time Frame: 1 year
adherence to medical regimen using a Visual Analog scale. Specific regimen depends on initial diagnosis
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Maria L Ekstrand, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

December 2, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimate)

December 8, 2014

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 4, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH100311 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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