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CTRI Number  CTRI/2017/10/009992 [Registered on: 04/10/2017] Trial Registered Retrospectively
Last Modified On: 29/09/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  
Behavioral 
Study Design  Other 
Public Title of Study
Modification(s)  
Trial of a primary health care mobile health system for identification and management of Common Mental Disorders in rural Andhra Pradesh  
Scientific Title of Study
Modification(s)  
The Systematic Medical Appraisal, Referral and Treatment (SMART) Mental Health Programme for Rural India  
Secondary IDs if Any  
Secondary ID  Registry 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Pallab K Maulik 
Address  George Institute For Global Health, Unit No 301, II Floor,ANR Centre, Opp to City Centre, Banjara Hills, Hyderabad

Hyderabad
ANDHRA PRADESH
500034
India 
Phone  04067314444  
Fax    
Email  pmaulik@georgeinstitute.org.in  
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Pallab K Maulik 
Address  George Institute For Global Health, Unit No 301, II Floor,ANR Centre, Opp to City Centre, Banjara Hills, Hyderabad

Hyderabad
ANDHRA PRADESH
500034
India 
Phone  04067314444  
Fax  04067314400  
Email  pmaulik@georgeinstitute.org.in  
 
Details Contact Person
Public Query

Modification(s)  
Name  Pallab K Maulik 
Address  George Institute For Global Health, Unit No 301, II Floor,ANR Centre, Opp to City Centre, Banjara Hills, Hyderabad

Hyderabad
ANDHRA PRADESH
500034
India 
Phone  04067314444  
Fax  04067314400  
Email  pmaulik@georgeinstitute.org.in  
 
Source of Monetary or Material Support
Modification(s)  
Grand Challenges Canada MaRS Centre, South Tower, 101 College Street, Suite 406,Toronto, Ontario, Canada M5G 1L7  
 
Primary Sponsor  
Name  Grand Challenges Canada 
Address  MaRS Centre, South Tower, 101 College Street, Suite 406,Toronto, Ontario, Canada M5G 1L7 
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 
Dr Pallab K Maulik  George Institute For Global Health  UNIT NO. 301 II Floor, ANR Centre, Banjara Hills Hyderabad – 500 034
Hyderabad
 
04067314444
04067314400
pmaulik@georgeinstitute.org.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Centre For Chronic Disease Istitutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Mental Health 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Mental Health service  The (Accreditated Social Health Activist-ASHAs)in the community screened for Common Mental Disorders in the community using PHQ9 and GAD 7 screening tool and referred the screen positive cases to the doctors at the Primary Healthcare centre. The doctors evaluated the referred cases using the MH GAP algorithm application and gave a proper diagnosis to their conditions and also provided treatment as per the need i.e. either psychological(i.e. counselling), medical(prescribing anti depressant medications) or a combination of both. Severe cases were referred to a specialist who was a psychiatrist. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All consenting adults ≥ 18 years of age. 
 
ExclusionCriteria 
Details  1) Physical ill-health or any health condition that would prevent regular follow-up, and intellectual disability that prevents the participant from following instructions or responding to the questionnaire.

2) Participant not likely to stay in the community for the duration of the intervention.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The key quantitative outcome of the study is the change from baseline in the proportion of individuals who have accessed the health system for management of a mental disorder in the previous 3 months  3 months 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
1)% of individuals who had an ASHA-administered PHQ922 and GAD723
2)% of individuals appropriately referred by the ASHA to the PHC doctor
3)Proportion of individuals appropriately referred by the PHC doctor for more specialised care
4)% of individuals appropriately prescribed anti-depressant or anxiolytic treatment
5)% of individuals with a PHQ922 and/or GAD723 score ≥10 amongst those who have accessed the health system for management of a mental disorder


 
10 months 
 
Target Sample Size   Total Sample Size="8000"
Sample Size from India="8000" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  
01/09/2015 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Pallab K Maulik,Sudha Kallakuri, Siddhardha Devarapalli,Vamsi Krishna Vadlamani,Vivekanand Jha, Anushka Patel, Increasing use of mental health services in remote areas using mobile technology: A pre-post evaluation of the SMART Mental Health project in rural India. Journal of Global Health;7(1):010408. doi: 10.7189/jogh.07.010408  
Brief Summary
Modification(s)  


It aims to develop and evaluate feasibility, acceptability and preliminary effectiveness of a multifaceted primary health care worker intervention. Intervention will utilize a mobile device based electronic decision support system based on mhGAP of WHO and will focus on identification and management of individuals (≥18years) with common mental disorders like depression, suicidal risk and emotional stress. Screening would be done by ASHAs and management by primary care doctors. The primary outcome will assess the change in use of mental health services.


Key Findings


Training was imparted to 21 ASHAs and 2 primary care doctors.

5007 of 5167 eligible individuals were screened, and 238 were

identified as being positive for common mental disorders and referred to the primary care doctors for further management. Out of

them, 2 (0.8%) had previously utilized mental health services. During

the intervention period, 30 (12.6%) visited the primary care doctor

for further diagnosis and treatment, as advised. There was a significant

reduction in the depression and anxiety scores between start

and end of the intervention among those who had screened positive

at the beginning. Stigma and mental health awareness in the broader

community improved during the project.

 

 

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