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CTRI Number  CTRI/2021/03/032254 [Registered on: 24/03/2021] Trial Registered Prospectively
Last Modified On: 15/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Nurse led brief intervention for reducing psychoactive substance use among elderly 
Scientific Title of Study   A Randomized controlled trial on the effectiveness of nurse led brief intervention to reduce risky use of psychoactive substance among members in the selected elderly organization of rohtak 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neeraj 
Designation  Msc Nursing Student 
Affiliation  Pt. BD Sharma university of health science 
Address  Department of Psychiatric Nursing, College of Nursing, PGIMS, ROHTAK

Rohtak
HARYANA
124001
India 
Phone  8708560696  
Fax    
Email  akhushi04387@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  JAISON JOSEPH 
Designation  LECTURER (JR) 
Affiliation  Pt. BD Sharma University of Health Sciences, Rohtak 
Address  Department of Psychiatric Nursing, College of Nursing, PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  9468277298  
Fax    
Email  jaisonjsph@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  JAISON JOSEPH 
Designation  LECTURER (JR) 
Affiliation  Pt. BD Sharma university of health science 
Address  Department of Psychiatric Nursing, College of Nursing, PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  9468277298  
Fax    
Email  jaisonjsph@yahoo.com  
 
Source of Monetary or Material Support  
Pandit BDS PGIMS, Rohtak 
 
Primary Sponsor  
Name  Pt BDS PGIMS Rohtak 
Address  College of Nursing, Pt BDS PGIMS Rohtak 
Type of Sponsor  Government medical college 
 
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 
JAISON JOSEPH  Pandit BDS PGIMS, Rohtak  College of Nursing, Department of Psychiatric Nursing, Pandit BDS PGIMS, Rohtak
Rohtak
HARYANA 
9468277298

jaisonjsph@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical research ethics committee, PGIMS, (UHS), Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Elderly with risky use of substances 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nurse led brief intervention  session 1: WHO ASSIST linked brief intervention Session: brief motivational structured module 
Comparator Agent  routine advice   routine advice with pamphlet 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  95.00 Year(s)
Gender  Male 
Details  1) the elderly member of selected elderly organizing with using the psychoactive substance available during study period.
2) The elderly members using the psychoactive substance who are willing to take part in the study 
 
ExclusionCriteria 
Details  1) patient were excluded from the stud who had attended an alcohol or and substance use treatment program.
2)The elderly member reported symptoms of withdrawal in the previous year 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Risky use of psychoactive substance use as per WHO ASSIST scale  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Psychological morbidity according to PHQ4  At baseline 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2021 
Date of Study Completion (India) 15/05/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Preparing for publication 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Title:- A Randomized Controlled Trial on the effectiveness of nurse led brief intervention to reduce risky use of psychoactive substance among members in the selected elderly organization of Rohtak.

·      Date collection method (plan for data collection):

The study will be conducted in 2 phases. The purpose of Phase I is to screen the subjects for moderate and high risk of substance use involvement (“screen positive” subjects) in order to obtain the requisite sample for the next phase.  The Phase II of the study will randomize the screen positive subjects to either ASSIST-linked BI (Intervention Group) or to non-specific general advice (Control Group).

In the Phase II of the study, Screen positive subjects (Moderate and High Risk) will be first administered the other research instruments (Socio-Demographic Performa, Clinical Performa, PHQ-4). After this, they will be randomized into Intervention group and control group.

Randomization: Block randomization will be used and equal numbers of participants into each group (intervention & control groups)

Allocation concealment: Allocation concealment will be ensured by using sequentially numbered sealed envelopes.  Following the written informed consent, the nurse will open a sealed envelope which will reveal the treatment allocation and the allocation in these envelopes will be determined by block-randomization process.

Blinding: The study will be a single blinded study in which those who conduct follow-up assessment will be blinded to treatment allocation.

After randomization, the Intervention group will be administered WHO ASSIST-linked BI package (approx.15-30 min single session). Brief Intervention is based on Motivational interviewing and FRAMES Model. It is a structured therapy of short duration (15- 30 minutes) is offered with an aim to help a person to reduce the use of substance. Session consists of discussing individualized harmful consequences of using substance, establishing clear link between substance consumption and the consequences, emphasizing the patient’s personal responsibility to change, evaluation of high risk situations, implementation of alternative highs, advice on coping strategies with facilitating self-efficacy and optimism. During intervention subjects will also be offer options to consult various treatment centre if they are in need.

 
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