| CTRI Number |
CTRI/2023/08/056708 [Registered on: 21/08/2023] Trial Registered Prospectively |
| Last Modified On: |
21/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Tapping into thinking through mobile apps in schizophrenia |
|
Scientific Title of Study
|
Scalable Digital Phenotyping for Momentary Cognition in Early Psychosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Urvakhsh M Mehta |
| Designation |
Additional Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Dept of Psychiatry, Room 17
NIMHANS, Hosur Road, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995805 |
| Fax |
|
| Email |
urvakhsh@nimhans.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Urvakhsh M Mehta |
| Designation |
Additional Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Dept of Psychiatry, Room no. 17
NIMHANS, Hosur Road, Bengaluru
KARNATAKA
560029
India |
| Phone |
08026995805 |
| Fax |
|
| Email |
urvakhsh@nimhans.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Urvakhsh M Mehta |
| Designation |
Additional Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Dept of Psychiatry, Room no. 17
NIMHANS, Hosur Road, Bengaluru
KARNATAKA
560029
India |
| Phone |
08026995805 |
| Fax |
|
| Email |
urvakhsh@nimhans.ac.in |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India
All India Institute of Medical Sciences (AIIMS), Bhopal
Sangath, Bhopal |
|
|
Primary Sponsor
|
| Name |
Beth Israel Deaconess Medical Center (BIDMC) |
| Address |
Beth Israel Deaconess Medical Center
330 Brookline Avenue
Boston, MA 02215 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
United States of America |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhijit R Rozatkar |
All India Institute of Medical Sciences (AIIMS) |
Department of Psychiatry, AIIMS Campus Rd, AIIMS Campus, Saket Nagar, Habib Ganj, Bhopal
Bhopal
MADHYA PRADESH |
07552835096
abhijit.psy@aiimsbhopal.edu.in |
| Dr Urvakhsh M Mehta |
National Institute of Mental health and Neurosciences |
Department of Psychiatry, Room no. 17, Hosur Road Bangalore-
560029
Bangalore
KARNATAKA |
08026995805
urvakhsh@nimhans.ac.in |
| Dr Anant Bhan |
Sangath |
Plot No. 106, Good Shepherd Colony, Danish Kunj, Kolar Rd, Bhopal
Bhopal
MADHYA PRADESH |
7747012060
anant.bhan@sangath.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, Bhopal |
Approved |
| Institute Ethics Committee, NIMHANS |
Approved |
| SANGATH INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosis of a psychotic disorder
2.Severity of symptoms at least to a mild degree on The Positive and Negative Syndrome Scale (PANSS) over the past 3 months
3.If prescribed, a stable medication dosage for at least the past month (self-report and clinical records)
|
|
| ExclusionCriteria |
| Details |
1.Substance use disorder during the last 3 months
2.Benzodiazepines in the last 4 weeks |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess changes in micro cognitive & contextual momentary performance metrics as correlated to changes in functioning, positive symptoms of schizophrenia, and any changes in the MATRICS Consensus Cognitive Battery (MCCB) |
0,90,and180days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess changes in micro cognitive & contextual momentary performance in relation to functioning and psychotic-like experiences |
0,90,and180days |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/09/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/06/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In the current study we propose to address challenges around the assessment of
cognition as well as its measurement in the context of different
environments and circadian terms through a novel concept called
micro cognitive and contextual momentary performance. Micro
cognitive and contextual momentary performance metrics involve
two core elements captured simultaneously: 1) brief self-
administered scalable smartphone measures of cognitive
performance; and 2) digital phenotyping measures of symptoms,
activity levels, sleep patterns, and related functional /
environmental factors. These related functional / environmental
factors include metrics about the immediate environment (light,
ambient sound levels, social density) and personal state (sleep,
mobility, and activity metrics). These micro cognitive and
contextual momentary performance metrics are designed to be
offered multiple times per day via a smartphone and thus represent
a scalable means to bring novel cognitive performance
measurement into the hands of millions of people with
schizophrenia.
In this study, we will co-develop a battery of these assessments
designed to measure those cognitive domains most impacted in
early course schizophrenia, refine that battery in pilot testing, and
finally assess the potential of our micro cognitive and contextual
momentary performance metrics against functional outcomes with
personalized scoring controlling for differing environments and
circadian rhythms. Our goal is to introduce accessible micro
cognitive and contextual momentary performance metrics and
study their utility in assessing real world functioning and symptoms
in first episode schizophrenia. |