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CTRI Number  CTRI/2025/04/085495 [Registered on: 24/04/2025] Trial Registered Prospectively
Last Modified On: 06/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Emotional Intelligence Training Program in Opioid Use Disorder Treatment 
Scientific Title of Study   Effect of emotional intelligence intervention on alexithymia and mental health in individuals with opioid use disorder: A study in Nagaland. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nenchu Kath 
Designation  PhD Scholar 
Affiliation  Nagaland University 
Address  Department of Psychology, Nagaland University, Kohima Campus, Meriema, Nagaland, 797004

Kohima
NAGALAND
797004
India 
Phone  8794825832  
Fax    
Email  nenchukath@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Imlisongla Longkumer 
Designation  Associate Professor 
Affiliation  Nagaland University 
Address  Department of Psychology, Nagaland University, Kohima Campus, Meriema, Nagaland, 797004

Kohima
NAGALAND
797004
India 
Phone  9402697023  
Fax    
Email  imlilongkumer@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Nenchu Kath 
Designation  PhD Scholar 
Affiliation  Nagaland University 
Address  Department of Psychology, Nagaland University, Kohima Campus, Meriema, Nagaland, 797004

Kohima
NAGALAND
797004
India 
Phone  8794825832  
Fax    
Email  nenchukath@gmail.com  
 
Source of Monetary or Material Support  
Department of Psychology, Nagaland University, Kohima Campus, Meriema, Nagaland 797004 
 
Primary Sponsor  
Name  Nenchu Kath 
Address  Department of Psychology, Nagaland University, Kohima Campus, Meriema, Nagaland 797004 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Nenchu Kath  Bethesda Youth Welfare Centre  Intregrated Rehabilitation Centre for Addicts (IRCA),
Dimapur
NAGALAND 		 8794825832

nenchukath@gmail.com 
Nenchu Kath   Dimapur Life Challenge   Life Challenge Nagaland, Hall no. 1, 6th Mile,Tenyiphe-1, Chumoukedima district
Dimapur
NAGALAND 		 8794825832

nenchukath@gmail.com 
Nenchu Kath   Prodigals Home  Integrated Rehabilitation Centre for Addicts (IRCA), H.NO.101, Fellowship Colony
Dimapur
NAGALAND 		 8794825832

nenchukath@gmail.com 
Nenchu Kath   Shalom Rehabilitation Centre  Shalom Rehabilitation Centre, Counselling room,7th Mile, Chumoukedima District
Dimapur
NAGALAND 		 8794825832

nenchukath@gmail.com 
Nenchu Kath  Silas Care and Welfare Society  Silas Womens Rehabilitation Centre, Sensolikum near Indisen futsal ground
Dimapur
NAGALAND 		 8794825832

nenchukath@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Department Ethics Committee, Department of Psychology, Nagaland University  Approved 
Department Ethics Committee, Department of Psychology, Nagaland University  Approved 
Department Ethics Committee, Department of Psychology, Nagaland University  Approved 
Department Ethics Committee, Department of Psychology, Nagaland University  Approved 
Department Ethics Committee, Department of Psychology, Nagaland University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F112||Opioid dependence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Emotional intelligence intervention  Eight weekly sessions on emotional intelligence intervention will be held for eight weeks. Each session will last two hours and will be conducted in group-based, in-person format. 
Comparator Agent  Nil  Participants in the control group will receive treatment as usual (TAU), defined as the standard care routinely provided by their respective rehabilitation centers without the addition of the Emotional Intelligence intervention. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Enrolled in rehabilitation centres for opioid treatment program
2. Newly admitted to the rehabilitation centres and have completed the detoxification phase
3. Individuals who meet the DSM 5 criteria for moderate to severe OUD determined by ROUDA
4. Based on the baseline assessment participants with low and moderate EI will be selected for the study
5. Both naga and non-naga
6. minimum 8th grade education who can read and understand English
7. Ability to provide informed consent to participate in the study 
 
ExclusionCriteria 
Details  1. Individuals with a history of comorbidity psychiatric disorder will be excluded.
2. Individuals who had the experience of EI intervention will be excluded. 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the change in emotional intelligence scores between the intervention group and the control group of individuals with opioid use disorder.  pre (Baseline), post (8 weeks), and follow-up (12 weeks for intervention group) 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the change in alexithymia scores between the intervention group & the control group of individuals with opioid use disorder.

To compare the change in mental health scores between the intervention group & the control group of individuals with opioid use disorder. 		 pre (Baseline), post (8 weeks), & follow-up (12 weeks for intervention group)  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   12/05/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Opioid remains the most lethal group of drugs, significantly contributing to the global burden of disease. Addressing the emotional and psychological factors associated with opioid use disorder is critical, particularly in regions with high prevalence rates such as Nagaland, India. According to the 2019 National Survey, 6.50% of Nagaland’s population is affected by opioid-related issues. Emotional deficits can lead to negative psychological outcomes and hinder effective coping strategies, making it essential to explore how EI can be leveraged in treatment. While existing EI intervention studies primarily focus on healthy adults, there remains a significant gap in understanding how EI can specifically benefit individuals struggling with substance addiction. The study aims to evaluate the effectiveness of EI intervention on EI, alexithymia, and the mental health of individuals with opioid use disorder. The baseline assessment will include the administration of the questionnaire to evaluate EI, alexithymia, and mental health. Additionally, individuals meeting DSM 5 criteria for moderate to severe opioid use disorder will be identified. The EI intervention program includes 8 modules spread over 8 weeks, with 1 session held each week. 
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