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.