| CTRI Number |
CTRI/2018/04/013001 [Registered on: 04/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
15/10/2024 |
| 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
|
|
|
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
|
|
|
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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1.Srinivasan K, Heylen E, Pradeep J, Prem.K.Mony, Ekstrand ML. Collaborative care compared to enhanced standard treatment of depression with co-morbid medical conditions among patients from rural South India: A cluster randomized controlled trial (HOPE study). BMC Psychiatry 2022, 22: 394, doi.org/10.1186/s12888-022-04000-3.
2.Srinivasan K, Mazur A, Mony PK, Whooley M, Ekstrand ML. Improving mental health through integration with primary care in rural Karnataka: Study protocol of a cluster randomized controlled trial. BMC Family Practice 19:158, 2018, doi.org/10.1186/s 12875-018-0845-z
3.Thomas S, Srinivasan K, Heylen E, Ekstrand ML. Correlates of social support in individuals with a diagnosis of common mental disorders and non-communicable medical diseases in rural south India. Social Psychiatry and Psychiatric Epidemiology doi:10.1007/s00127-020-01997-4.doi.org/10.1016/j.jadr.2020.100071. |
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 |
