FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/05/013600 [Registered on: 02/05/2018] Trial Registered Retrospectively
Last Modified On: 08/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   A study to assess how feasible and effective are family interventions addressing expressed emotions of opioid substitution therapy recipients. 
Scientific Title of Study   “Feasibility and Effectiveness of Family Intervention Addressing Expressed Emotions in Recipients of Opioid Substitution Therapy: A Randomised Controlled Study” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vasudha Singh 
Designation  Ph.D.Scholar 
Affiliation  AIl India Institute Of Medical Sciences 
Address  Dept.of Psychiatry,All India Institute Of Medical Sciences Ansari Nagar New Delhi
Dept.of Psychiatry,All India Institute Of Medical Sciences Ansari Nagar New Delhi
South West
DELHI
1100608
India 
Phone  9837464555  
Fax    
Email  vasudhairya@live.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Gauri Shanker Kaloiya 
Designation  Associate Professor Clinical Psychology 
Affiliation  AIl India Institute Of Medical Sciences 
Address  Rm No 4085-D All India Institute Of Medical Sciences Ansari Nagar
Rm.No 4085-B All India Institute Of Medical Sciences
South West
DELHI
1100608
India 
Phone  8178286632  
Fax    
Email  gkaloiya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gauri Shanker Kaloiya 
Designation  Associate Professor Clinical Psychology 
Affiliation  AIl India Institute Of Medical Sciences 
Address  4085-D Dept. of Psychiatry All India Institute Of Medical Sciences
4085-D Dept. of Psychiatry All India Institute Of Medical Sciences
South West
DELHI
1100608
India 
Phone  8178286632  
Fax    
Email  gkaloiya@gmail.com  
 
Source of Monetary or Material Support  
NDDTC,AIIMS Sector-19,Cgo Complex, Kamla Nehru Nagar,Bsr Road, Uttar Pradesh 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences 
Address  All India Institute Of Medical Sciences Ansari Nagar,New Delhi 1100608 
Type of Sponsor  Research institution and hospital 
 
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 
DrGauri Shanker Kaloiya  National Drug Dependence Treatment Centre,AIIMS  Dept. of Psychiatry,AIIMS, Sector-19,Cgo Complex, Kamla Nehru Nagar,Bsr Road, Uttar Pradesh
Ghaziabad
UTTAR PRADESH 		 8178286632

gkaloiya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Absence of any serious medical or psychiatric illness which may interfere with interview process  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  High Expressed Emotion Family Member  High expressed emotion family member will be given six session of family therapy with pre and post assessment 
Comparator Agent  High Expressed emotion family member   High expressed emotion family members will be given one session of basic psychoeducation and post assessment done as in intervention group. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects
1 Male patients
2 Age range of 18-60 years
3 Initiated on buprenorphine maintenance treatment for minimum of two weeks and maximum of 4 Weeks
Family Member
1 Related by blood or marriage and living with the patient in the same house since at least past one year
2 Age range from 18-60 years (either gender)
3 Living with the subject for at least past one year and will be with the patient during the course of the study period
4 Score >54 on Family Attitude Scale, corresponding to ‘high’ EE
5 Informed consent for interview and intervention


6 Informed consent for self and family interview and intervention
 
 
ExclusionCriteria 
Details  Subject
1 Individuals dependent on other psychoactive substances (except tobacco) in the past three months
2 Any serious medical illness which may interfere with interview process
3 Any psychiatric illness which may interfere with interview process•
Family Member
1 Any serious medical illness or psychiatric illness(including substance use disorders) which may interfere with interview process
2 Have received structured psychological intervention family intervention in past one year





 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
There will be decrease in expressed emotions of family members with six session of family interventions   6 weekly session in 8-10 weeks time  
 
Secondary Outcome  
Outcome  TimePoints 
There will be decrease in burden of family members in post assessment after intervention  6 week sessions in 8-10 weeks time 
There will be improvement in QOL of family members post assessment  6 weeks session within 6-8 weeks time 
There will be improvement of perceived critic of patients towards family members  6 weekly session within 8-10 weeks time 
There will be improvement in QOL of patients post intervention   6 weekly sessions within 8-10 weeks time 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "97"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   03/04/2017 
Date of Study Completion (India) 09/03/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  
The primary purpose of the study was to assess the feasibility and effectiveness of family intervention addressing expressed emotions of family members of recipients of opioid substitution therapy.The first objective was achieved.The first hypothesis that there will be decrease in expressed emotions with family interventions was also accepted.Further with high EE there was increased family burden and low quality of life.With decrease in expressed emotions there was decrease in burden and increase in quality of life.
To conclude the component of cognitive behaviour family therapy were able to address high expressed emotions of family members and family interventions were found to be feasible to carry out for the same.

 
Close