| CTRI Number |
CTRI/2017/04/008351 [Registered on: 13/04/2017] Trial Registered Retrospectively |
| Last Modified On: |
01/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Facial Emotion Recognition Training In Persons With Chronic Mental Illness (Schizophrenia) |
|
Scientific Title of Study
|
“Modification and Demonstration of Efficacy of an Existing Module for Affect Recognition Training in Schizophrenia†|
| Trial Acronym |
ARTS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
UMESH THONSE |
| Designation |
PhD Scholar |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Psychiatry
Room Number 33
Kasturba Medical College
Manipal University
Madhav Nagar, Near Tiger Circle, Manipal
Udupi District
Department of Psychiatry
Room Number 33
Kasturba Medical College
Manipal University
Madhav Nagar, Near Tiger Circle, Manipal
Udupi District
Udupi
KARNATAKA
576104
India |
| Phone |
09743579781 |
| Fax |
|
| Email |
umesh.tonse@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rishikesh V Behere |
| Designation |
Associate Consultant Psychiatrist |
| Affiliation |
KEM Hospital Research Center |
| Address |
Department of Psychiatry
KEM Hospital and Research Centre
489 Sardar Moodliar Road
Rasta Peth Pune
Maharashtra
Department of Psychiatry
KEM Hospital and Research Centre
489 Sardar Moodliar Road
Rasta Peth Pune
Maharashtra
Pune
MAHARASHTRA
411011
India |
| Phone |
09449519078 |
| Fax |
|
| Email |
rvbehere@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
UMESH THONSE |
| Designation |
PhD Scholar |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Psychiatry
Room Number 33
Kasturba Medical College
Manipal University
Madhav Nagar Near Tiger Circle Manipal
Udupi District
Department of Psychiatry
Room Number 33
Kasturba Medical College
Manipal University
Madhav Nagar Near Tiger Circle Manipal
Udupi District
Udupi
KARNATAKA
576104
India |
| Phone |
09743579781 |
| Fax |
|
| Email |
umesh.tonse@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Social Science Research
JNU Institutional Area
Aruna Asaf Ali Marg
New Delhi- 110067
INDIA |
|
|
Primary Sponsor
|
| Name |
Indian Council of Social Science Research |
| Address |
Indian Council of Social Science Research
JNU Institutional Area
Aruna Asaf Ali Marg
New Delhi 110067
INDIA |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Umesh Thonse |
Kasturba Medical College Manipal |
Department of Psychiatry,
Room Number 33
Kasturba Medical College
Manipal University
Madhav Nagar, Near Tiger Circle, Manipal
Udupi District
Udupi
KARNATAKA |
08202922217
umesh.tonse@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manipal University Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Only remitted schizophrenia patients were included in this study. Hence they were able to focus on training program. their symptoms of schizophrenia were in control., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Affect Recognition Training |
This is facial emotion training program. It is consisted with 12 sessions for twice a week sessions for 12 weeks. Basically it teaches how to identify facial emotions correctly and how to understand social situations in day to day social situations. This training program specifically developed for schizophrenia patients. This intervention program basically developed in German. Hence it can be applied directly in Indian patients population. Henceforth researcher has modified this training program with the help of co-guide of this study. |
| Comparator Agent |
Treatment As Usual (TAU) |
This group considered as control group patients. Here patients are continued to receive all their routine treatment as usual without any changes. They were all receiving their antipsychotic medications and other behavioural training programs such as occupation therapy, vocational rehabilitation program and social skill training programs. Even Intervention group was also receiving similar treatments but they had received add on affect recognition training program. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Persons who give consent for the study
2. Educated at least up to 7th standard and should be able to read Kannada.
3. Persons who meet the criteria of schizophrenia according to ICD 10.
4. PANSS score of ≤ 70
5. Clinical Global impression Severity(CGI-S) ≤3
6. Hindi Mental State Examination score >24
7. On stable dose of antipsychotic medication for last 4 weeks
|
|
| ExclusionCriteria |
| Details |
1. Patients with comorbid neurological disorder such as seizure disorder, stroke, head trauma or mental retardation.
2. Patients with comorbid depression or OCD on clinical interview.
3. Patients meeting criteria for substance dependence other than nicotine in the last 6 weeks.
4. During the intervention if patient shows signs of relapse, PANSS will be repeated and if he/she scores more than 70 in PANSS, he/she will be dropped from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome is improvement in facial emotion recognition.
|
Baseline to post assessment (one and half month) and the conducting two to three months of followup after the post assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| secondary outcome is improvement in attention and working memory |
Baseline to post assessment (one and half month) and the conducting two to three months of followup after the post assessment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "65"
Final Enrollment numbers achieved (India)="65" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/09/2014 |
| Date of Study Completion (India) |
30/06/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/06/2019 |
|
Estimated Duration of Trial
|
Years="3"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Researcher has prepared for two manuscripts and they are in the process of publication.
Article has already for the publication in Scopus indexed journal. It is currently under review. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Schizophrenia is one of the chronic mental illness and one among the global burden of diseases. It effect not only individual it also effects family member and whole society. schizophrenia patients basically faces deficits in their self care, interpersonal relationships, communication and in their occupation and in family life. Research studies have already established that schizophrenia patients also have cognitive disabilities. In recent time it also found that schizophrenia patients have social cognition deficits too. It means they have difficulty in understanding others emotions and social situations and attributional bias and deficits in their theory of mind. Western countries have already developed psychological inteventional programs to reduce this deficits and improve their social functioning. However in India we do have assessment tools for identifying these deficits but we do not have intervention program to reduce this deficits. Hence this study would like to fill this gap in research field as well as would like to help our patients population in reducing their deficits in social cognition. Researcher hypothesis is this intervention program will help in reducing facial emotion recognition deficits in schizophrenia patients.
Results: In this study person with schizophrenia (study group) found statistically significant improvement in their ability in identifying facial emotions than control group patients. However there was no significant improvement noticed in patients socio-occupational functioning after the intervention program. It may be also possible that training of affect recognition influence higher order social functioning which is not assessed by socio-occupational functioning scale (SOFS). Hence it require further studies on these area with more number of sample size and adequate socio occupational functioning assessment scale which can assess the improvement occurred due to the emotion recognition training program. |