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CTRI Number  CTRI/2022/01/039333 [Registered on: 11/01/2022] Trial Registered Prospectively
Last Modified On: 04/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to develop a non pharmacological therapeutic tool to reduce the self stigma in caregivers of people with severe mental illnesses. 
Scientific Title of Study   A study to develop and assess the effect of Single Session Psychoeducation Based Intervention (SSPBI) on Affiliate stigma among caregivers of people with severe mental illnesses: A Randomised Control Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tanve Garg 
Designation  Junior Resident 
Affiliation  AIIMS, Rishikesh 
Address  Department of Psychiatry, All India Institute of Medical Sciences, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  7009710599  
Fax    
Email  tanve6garg@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tanve Garg 
Designation  Junior Resident 
Affiliation  AIIMS, Rishikesh 
Address  Department of Psychiatry, All India Institute of Medical Sciences, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  7009710599  
Fax    
Email  tanve6garg@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vishal Dhiman 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Psychiatry, All India Institute of Medical Sciences, Rishikesh

Dehradun
UTTARANCHAL
249293
India 
Phone  9717329148  
Fax  01352452940  
Email  vishal.psyc@aiimsrishikesh.edu.in  
 
Source of Monetary or Material Support  
Not Applicable 
 
Primary Sponsor  
Name  Dr Tanve Garg 
Address  Department of Psychiatry, All India Institute of Medical Sciences, Veerbhadra road, Rishikesh Dehradun 249203 Uttaranchal India 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tanve Garg  All India Institute of Medical Sciences  Department of Psychiatry, All India Institute of Medical Sciences, Veerbhadra road, RISHIKESH
Dehradun
UTTARANCHAL 		 7009710599

tanve6garg@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS, Rishikesh Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Primary Caregivers of Patients who have severe mental illnesses  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conducting non psychoeducative placebo session   Each session will be of same time as the SSPBI session (10-15 mins )  
Comparator Agent  Conducting SSPBI session  Each session will require 10-15 mins in which the caregivers of people with severe mental illnesses will be given SSPBI Session with aim to reduce the affiliate stigma. 
Intervention  Single Session Psychoeducation Based Intervention (SSPBI)  SSPBI is non invasive, simple to use (single session), feasible ( easy to administer by any mental health professional) and is applicable across different settings ( like outpatients, inpatients and telemedicine etc) and through different modalities (one to one counselling, telephonically / remote application, multimedia assisted etc.) which aims to reduce affiliate stigma among caregivers of people with severe mental illnesses. Each session would be of total duration of 10- 15 minutes for each subject. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Primary Caregivers within the age group of 18-60 years
2. Caregivers of people who are suffering from SMI (as per ICD 10)
for >3 months (and not more than 5 years).
3. Those consenting to participate in the study. 
 
ExclusionCriteria 
Details  1. Caregivers of patients with age <18 year or >60 years
2. People who do not give consent.
3. Caregivers’ self-report of any significant psychiatric disorder at present or in the past.
4. Caregivers’ or Patients’ self-report of significant substance use in patterns of harmful use/ dependant at present or in the past.
5. Caregivers’ or Patients’ self report of significant and visible physical disability at present or in the past.
6. Does not understand English / Hindi language 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1) Change in Affiliate Stigma Scores measured by Affiliate Stigma Scale (ASS) within 48 hours after intervention.
2) Difference in reduction in affiliate stigma across 2 groups : direct contact and distance contact groups
3) Difference in reduction in affiliate stigma across intervention groups and control groups.
 		 Measurement will be done at 3 points:
1) At baseline on day 1 before conducting SSPBI session
2) Within 48 hours of application of SSPBI Session
3) 3 weeks after the application of SSPBI session
 
 
Secondary Outcome  
Outcome  TimePoints 
1) Levels of affiliate stigma among caregivers of patients who are suffering with SMI
2) level of affiliate stigma 3 weeks after intervention 		 Baseline At day 1 before applying SSPBI and 3 weeks after giving SSPBI 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   20/01/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   “The term stigma connotes a deep mark of shame and degradation carried by a person as a function of being a member of a devalued social group.”When the caregiver is affected by the prevailing public stigma, also understood as self‑stigma in caregivers of people with mental illness. Caregivers are involved in treatment related decisions for patient. Affiliate-stigma is important for treatment non-adherence, poorer course and outcome of the illness, poor quality of life, low self esteem and many more. So, there is a Need to understand the extent of caregivers’ affiliate-stigma and its correlates and to target with appropriate intervention. A Number of psychoeducative interventions are available, mostly lengthy, time consuming, require direct contact, demand a lot of professional expertise and experience, are situation specific (particular setting), have differential effectiveness and are illness specific. SSPBI will be short i.e. single session, feasible (easy to administer by any mental health professional) and applicable across different settings (like outpatient, inpatient, telemedicine, etc.) and through different modalities (one-to-one counselling, telephonically / remote application, multimedia assisted, etc.)
Study is divided into two phases: 
PHASE I: Development of SSPBI : A draft of SSPBI will be prepared after reviewing the literature on effective measures to reduce stigma which would then be sent for approval by a review committee consisting of Psychiatrists/ Psychologists/ Social Workers. After making necessary suggested changes, a Pilot study for SSPBI will be done. A final SSPBI would be prepared.
PHASE II: Application of SSPBI and Evaluating it’s effect on affiliate stigma : SSPBI would then be applied to intervention group caregivers of people with severe mental illnesses after computerised randomisation via direct contact (OPD) and distance contact (telephonically/ video call) and changes in Affiliate stigma scores would be assessed immediately (within 48 hours ) and after 3 weeks of intervention and compared to the baseline.
 
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