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CTRI Number  CTRI/2025/12/099010 [Registered on: 12/12/2025] Trial Registered Prospectively
Last Modified On: 12/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to find the effectiveness of stress reduction teachings to help reduce stress and risk for relapse in individuals receiving treatment for alcohol use, at CMC, Vellore Outpatient Clinic 
Scientific Title of Study   A RCT to evaluate the effectiveness of Stress Reduction Programme on stress, severity of dependence and risk for relapse among patients with Alcohol Dependence Syndrome, attending outpatient department of Psychiatry CMC, Vellore. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mrs Jeeva Sebastian 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Principal Investigator Room No. 231, Nursing Faculty room, 1st floor, Mental Health Centre, Christian Medical College, Vellore

Vellore
TAMIL NADU
632014
India 
Phone  09894893794  
Fax    
Email  jeevachristopher27@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mrs Jeeva Sebastian 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Principal Investigator Room No. 231, Nursing Faculty room, 1st floor, Mental Health Centre, Christian Medical College, Vellore

Vellore
TAMIL NADU
632014
India 
Phone  09894893794  
Fax    
Email  jeevachristopher27@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mrs Jeeva Sebastian 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Data collection at Room 114, Data collection room, ground floor, Mental Health Centre, Christian Medical College, Vellore

Vellore
TAMIL NADU
632014
India 
Phone  09894893794  
Fax    
Email  jeevachristopher27@gmail.com  
 
Source of Monetary or Material Support  
Institutional Review Board, Christian Medical College, Vellore - 632 002, Tamil Nadu, India 
 
Primary Sponsor  
Name  Mrs Jeeva Sebastian 
Address  Nurse Manager, Mental Health Centre, Bagayam 
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 
Mrs Jeeva Sebastian  Mental Health Centre, Christian Medical College, Vellore  Dr Priya Mammen Room 103, ground floor, Mental Health Centre, Christian Medical College, Vellore
Vellore
TAMIL NADU 
09894893794

jeevachristopher27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F102||Alcohol dependence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparison group  The control group will be involved in the routine care, but the researchers will not teach stress management or stress reduction till the research study get over. They will have 8 sessions: Each session for 15 minutes. 1. Introduction, Baseline assessment (levels of stress, risk of Alcohol reuse/ relapse, and severity of alcohol dependence). 2. Discussions on -General well-being. 3. Discussions on -Disease process, Elicit Alcoholic history. 4. Discussions on Health promotion (Well-balanced Diet, exercise) 5. Discussions on Management of ADS (pharmacological, non-pharmacological). 6. Discussions on - Complications of ADS. 7. Summarising and clearing their queries. 8. Post assessment I -will be done by co-investigators. Post Assessment II will be after 6 months 
Intervention  Stress reduction and relapse prevention programme  Patient: Alcohol Dependence syndrome Intervention: Education on Stress Reduction Comparison: Pre and Post comparison of Stress Outcome: Stress reduction, Relapse prevention, Decreased severity of dependence Time: Each session for 45 minutes. Interventional group --will be involved in the stress management/ reduction programme. 1. Introduction , orientation to the program and Baseline Assessment. 2. Discussion on Alcohol Dependence Syndrome. 3. Relaxation Training, Demonstration and return demonstration of deep breathing exercise ,Progressive muscle relaxation techniques (by video). 4. Overcoming triggers and cravings. 5. Improving self esteem and Assertiveness training. 6. Psycho education on Stress management techniques: Eustress, types of stress, identifying stressors, ways to deal with stress, Role play on handling stress related situations. 7. Revision of sessions and clarification of doubts. 8. Post assessment I -will be after 3 months. Post Assessment II - will be after 6 months.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  Patients who are between 18 -65 years.
Patients who meet the ICD-10 criteria of Alcohol Dependence Syndrome (F 10.3)
Patients who have an index visit to MHC, irrespective their number of episodes and on Alcohol use more than 1 year.
Patients who are willing to provide written informed consent to participate this study.
Patients who can understand and speak in Tamil and English
 
 
ExclusionCriteria 
Details  Patients who have any severe physical illness or sensory impairment should not undergo the assessment.
Substance-induced co-morbidity
Patients with ADS who also have dependence on other substances except nicotine
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Stress  Stress 
 
Secondary Outcome  
Outcome  TimePoints 
Relapse Prevention
Risk for Relapse 
6 months 
 
Target Sample Size   Total Sample Size="344"
Sample Size from India="34" 
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   Phase 1 
Date of First Enrollment (India)   29/12/2025 
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="26"
Months="6"
Days="16" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Title: A RCT to evaluate the effectiveness of Stress Reduction Programme on stress, severity of dependence and risk for relapse among patients with Alcohol Dependence Syndrome, attending outpatient department of CMC, Vellore.

 Objective / Aims:

1. To assess stress, severity of alcohol dependence and risk for relapse among patients with Alcohol Dependence Syndrome.

2. To evaluate the effectiveness of Stress Reduction program among patients with Alcohol Dependence Syndrome.

3. To find the relationship between stress, severity of alcohol dependence and risk for relapse among patients with Alcohol Dependence Syndrome.

4. To determine the association between stress and selected socio-demographic and clinical variables of patients with Alcohol Dependence Syndrome.


Hypothesis: There will be a significant difference in the patient outcome between the pre-intervention and post-intervention groups.

 

Expected results/outcome:

The findings would serve as an empirical basis to plan for an ongoing educational program related to Alcohol Dependence Syndrome, treatment, stress reduction, relapse prevention and management of patients with Alcohol Dependence Syndrome. Findings on demographic characteristics and clinical variables would help in identifying the factors that affect the severity of dependence, risk factors for relapse in Alcoholic patients. Relationship between the level of stress, severity of dependence, risk factors for relapse and the effectiveness of stress reduction program would help nurses to improve better understanding about relapse/ readmission therefore help in increasing stress reduction interventions to the patients with Alcohol Dependence Syndrome.

The results of the study would thus enable psychiatric nurses and the health team members to give psycho education through a stress reduction program. Stress management is more effective for patients with Alcohol Dependence Syndrome and should be based on the social and cultural background of the patients. With the growing emphasis on outpatient short-term treatment, psychiatric nurses are in a key position to lead psycho education groups and interventions which will meet the needs of patients and their families. Psychiatric nurses will be able to motivate the patients to quit alcohol intake and stay sober. This will also help the patient to understand their stress level, how to cope with stress, and prevent relapses, which eventually will increase the quality of life in patients with Alcohol Dependence Syndrome.

Innovations / Applications:  This study can provide insights for researchers, clinicians and nurses; it can guide them in tailoring treatment plans by emphasising the most effective stress reduction techniques, thereby improving the overall well-being of alcohol dependent patients. This study can inform further research and development of more effective stress reduction interventions, potentially leading to better treatment approaches for Alcohol dependence in clinical settings. The future plan is to start a de-addiction nursing program at the Mental Health Centre, CMC, Vellore. 

 
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