| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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.
|
|
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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
|
|
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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
|
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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. |