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CTRI Number  CTRI/2021/02/031005 [Registered on: 04/02/2021] Trial Registered Prospectively
Last Modified On: 14/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Behavioral 
Study Design  Other 
Public Title of Study   Effect of a Nursing Intervention Package on Adults with Substance Use Disorder 
Scientific Title of Study   Effectiveness of a Nursing Intervention Package on Adults with Substance Use Disorder 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  L Iris Devi 
Designation  Ph D Scholar 
Affiliation  Lokopriyo Gopinath Bordoloi Regional Institute of Mental Health 
Address  Department of Psychiatric Nursing, Lokopriyo Gopinath Bordoloi Regional Institute of Mental Health, Tezpur

Sonitpur
ASSAM
784001
India 
Phone  8638282925  
Fax    
Email  airishdevi91@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arunjyoti Baruah 
Designation  HOD & Professor 
Affiliation  Lokopriyo Gopinath Bordoloi Regional Institute of Mental Health 
Address  Department of Psychiatric Nursing, Lokopriyo Gopinath Bordoloi Regional Institute of Mental Health, Tezpur

Sonitpur
ASSAM
784001
India 
Phone  9435380045  
Fax    
Email  arunjyotibaruah@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  L Iris Devi 
Designation  Ph D Scholar 
Affiliation  Lokopriyo Gopinath Bordoloi Regional Institute of Mental Health 
Address  Department of Psychiatric Nursing, Lokopriyo Gopinath Bordoloi Regional Institute of Mental Health, Tezpur

Sonitpur
ASSAM
784001
India 
Phone  8638282925  
Fax    
Email  airishdevi91@gmail.com  
 
Source of Monetary or Material Support  
Lokopriyo Gopinath Bordoloi Regional Institute of Mental Health, Tezpur 
 
Primary Sponsor  
Name  L Iris Devi 
Address  Department of Psychiatric Nursing, Lokopriyo Gopinath Bordoloi Regional Institute of Mental Health, Tezpur 
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 
L Iris Devi  Lokopriyo Gopinath Bordoloi Regional Institute of Mental Health  Drug Deaddiction Centre
Sonitpur
ASSAM 		 8638282925

airishdevi91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, LGBRIMH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F10-F19||Mental and behavioral disorders due to psychoactive substance use,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nursing Intervention Package  Structured package consisting of various types of interventions planned on daily basis which range from Motivational Enhancement Therapy, Group therapy, Activity Scheduling, Exercise, Recreational therapy and other interventions tailored to meet the outcome etc. 
Comparator Agent  Routine care  Regular care and therapies depending on the patient 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Male 
Details  Patients who are using substances for more than six months.
He should be diagnosed with Substance use disorder as per ICD 10 criteria.
Patients admitted in the DDC ward
Those who can speak, understand and read English/ Assamese.
 
 
ExclusionCriteria 
Details  Patients who have Brief Psychiatric Rating Scale score more than 30
Patients having major medical comorbidity and those with severe withdrawal symptoms
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in Psychological wellbeing, Resilience, Self efficacy and Coping  3 month after discharge 
 
Secondary Outcome  
Outcome  TimePoints 
Finding out the Nursing Care Needs of persons with Substance Use Disorder  at end of Phase 1 
Improvement in Psychological wellbeing, Resilience, Self efficacy and Coping  at discharge, 1 month of discharge and 3 month of discharge 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "82"
Final Enrollment numbers achieved (India)="82" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/02/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response (Others) -  researchers who would access the files

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  at the university and other digital thesis repository which will be decided later

  6. For how long will this data be available start date provided 01-04-2023 and end date provided 01-01-2035?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Substance use is one of the major problem faced globally resulting in both mortality and morbidity across the globe. The present study has an aim to assess the psychological well-being, coping, self efficacy and resilience of persons with substance use disorder as they are a vulnerable group. The study approach will be a mixed method with quasi experimental design phase which focuses on assessing the nursing needs and designing a structured intervention based on the needs and finally assessing the effectiveness of the nursing intervention package.  
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