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临床试验/NCT02310932
NCT02310932已完成不适用

Improving Mental Health Through Integration With Primary Care in Rural Karnataka

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 2,507 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,507
试验地点
2
主要终点
blood pressure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

blood pressure

时间窗: 1 year

for patients presenting with hypertension

cholesterol

时间窗: 1 year

for patients presenting with hypercholesterolemia

blood glucose control

时间窗: 1 year

for patients presenting with diabetes

incidence of dually diagnosed participants

时间窗: 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

时间窗: 1 year

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

次要结局

  • medication adherence(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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