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Clinical Trials/NCT02310932
NCT02310932CompletedNot Applicable

Improving Mental Health Through Integration With Primary Care in Rural Karnataka

University of California, San Francisco1 site in 1 country2,507 target enrollmentStarted: February 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
2,507
Locations
1
Primary Endpoint
blood pressure

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
30 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Healthy Living Intervention

Experimental

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).

Intervention: Healthy Living Intervention (Behavioral)

Enhanced Standard Care Model

Placebo Comparator

Patients in control groups will receive an "enhanced standard" care model, which includes providing referrals for mental health needs.

Intervention: Healthy Living Intervention (Behavioral)

Outcomes

Primary Outcomes

blood pressure

Time Frame: 1 year

for patients presenting with hypertension

cholesterol

Time Frame: 1 year

for patients presenting with hypercholesterolemia

blood glucose control

Time Frame: 1 year

for patients presenting with diabetes

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.

anxiety or depression

Time Frame: 1 year

levels of anxiety or depression reported by participants, depending on initial diagnosis

Secondary Outcomes

  • medication adherence(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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