Clinical trial NCT02310932: Improving Mental Health Through Integration With Primary Care in Rural Karnataka
Official title: Improving Mental Health Through Integration With Primary Care in Rural Karnataka
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Depression
Anxiety
Keywords: mental health
cardiovascular disease
diabetes
hypertension
high blood pressure
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-12-08
Enrollment: 2507
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: incidence of dually diagnosed participants
timeFrame: 1 year
measure: anxiety or depression
timeFrame: 1 year
measure: blood glucose control
timeFrame: 1 year
measure: blood pressure
timeFrame: 1 year
measure: cholesterol
timeFrame: 1 year
Secondary outcomes:
measure: medication adherence
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangalore
country: India
facility: St. John & Research Institute/St John & Medical College & Hospital
state: Karnataka
Study officials:
affiliation: University of California, San Francisco
name: Maria L Ekstrand, MD
role: PRINCIPAL_INVESTIGATOR
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