CTRI Number	CTRI/2018/04/013001 [Registered on: 04/04/2018] Trial Registered Retrospectively
Last Modified On:	24/03/2018
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study Modification(s)	Diagnostic Screening Process of Care Changes Behavioral
Study Design	Cluster Randomized Trial
Public Title of Study	Improving Mental Health Through Integration With Primary Care in Rural Karnataka
Scientific Title of Study Modification(s)	Improving Mental Health Through Integration With Primary Care in Rural Karnataka.
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Krishnamachari Srinivasan  Address  St Johns Research Institute Koramangala Bangalore St Johns Research Institute Koramangala Bangalore Bangalore KARNATAKA 560034 India  Phone  9845038195   Fax     Email  srinivas@stjohns.in
Details Contact Person Scientific Query	Name  Krishnamachari Srinivasan  Address  St Johns Research Institute Koramangala Bangalore St Johns Research Institute Koramangala Bangalore Bangalore KARNATAKA 560034 India  Phone  9845038195   Fax     Email  srinivas@stjohns.in
Details Contact Person Public Query	Name  Krishnamachari Srinivasan  Address  St Johns Research Institute Koramangala Bangalore St Johns Research Institute Koramangala Bangalore Bangalore KARNATAKA 560034 India  Phone  9845038195   Fax     Email  srinivas@stjohns.in
Source of Monetary or Material Support	ST.JOHNS RESEARCH INSTITUTE,BANGALORE
Primary Sponsor	Name  National Institute of Mental Health  Address  National Institute of Mental Health USA  Type of Sponsor  Government funding agency
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Krishnamachari Srinivasan MD   St. Johns Research Institute   St. Johns Research Institute,St.Johns National Academy of health Sciences. Bangalore Karnataka India 560 034 Bangalore   9845038195 srinivasanstjohns@gmail.com
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  STJOHNSNATIONALACADEMYOFHEALTHSCIENCES  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  DIABETES,HIGH BLOOD PRESSURE,HIGH CHOLESTEROL,PSYCHOLOGICAL PROBLEMS
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Intervention  Multi-level intervention using a collaborative care model  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 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.  Comparator Agent  Enhanced standard non-integrated treatment  Primary care physicians will be provided training in the treatment of depression and anxiety and co-morbid medical conditions using standard treatment guidelines
Inclusion Criteria	Age From  30.00 Year(s) Age To  90.00 Year(s) Gender  Both  Details  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).
ExclusionCriteria	Details  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.
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment
Blinding/Masking	Participant, Investigator and Outcome Assessor Blinded
Primary Outcome	Outcome  TimePoints  Incidence of dually diagnosed participants anxiety or depression Blood glucose control blood pressure and cholesterol for patients presenting with diabetes hypertension hypercholesterolemia   1 year
Secondary Outcome	Outcome  TimePoints  medication adherence adherence to medical regimen using a Visual Analog scale. Specific regimen depends on initial diagnosis [Time Frame: 1 year  1 YEAR
Target Sample Size	Total Sample Size="2687" Sample Size from India="2687"
Phase of Trial	N/A
Date of First Enrollment (India)	27/04/2015
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="5" Months="0" Days="0"
Recruitment Status of Trial (Global)	Not Applicable
Recruitment Status of Trial (India)	Open to Recruitment
Publication Details	NA
Brief Summary Modification(s)	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 compared to enhanced standard care treatment. The primary outcome measures include  1. Incidence of dually diagnosed participants 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 levels of anxiety or depression reported by participants, depending on initial diagnosis 3. blood glucose control for patients presenting with diabetes 4. blood pressure for patients presenting with hypertension 5. cholesterol for patients presenting with hypercholesterolemia Secondary Outcome Measures: 6. medication adherence adherence to medical regimen using a Visual Analog scale. Specific regimen depends on initial diagnosis