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
|
|
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
|
|
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. |