| CTRI Number |
CTRI/2025/11/098085 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate the effect of nurse-directed intervention on depression, craving and severity of withdrawal symptoms among alcohol dependent patients taking treatment from out patient department of selected hospital of Bhubaneswar, Odisha . |
|
Scientific Title of Study
|
Effect of nurse led intervention on depression ,craving and withdrawal severity among alcohol dependent patients attending OPD in selected hospitals. |
| 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 Sanjukta Dixit |
| Designation |
Assistant Professor |
| Affiliation |
Kalinga Institute Of Nursing Sciences ,KIIT DU |
| Address |
Kalinga Institute Of Nursing Sciences, KIMS,KIIT Deemed To Be University,Campus-5 ,Patia, Bhubaneswar.
Khordha
ORISSA
751024
India |
| Phone |
9337800632 |
| Fax |
|
| Email |
sanjuktadixit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Sanjukta Dixit |
| Designation |
Assistant Professor |
| Affiliation |
Kalinga Institute Of Nursing Sciences ,KIIT DU |
| Address |
Kalinga Institute Of Nursing Sciences, KIMS,KIIT Deemed To Be University,Campus-5 ,Patia, Bhubaneswar.
Khordha
ORISSA
751024
India |
| Phone |
9337800632 |
| Fax |
|
| Email |
sanjuktadixit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Muthuvenkatachalm Srinivasan |
| Designation |
Associate Professor |
| Affiliation |
College Of Nursing, AIIMS Mangalagiri |
| Address |
College Of Nursing,
AIIMS Mangalagiri,
Guntur ,Andhra Pradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9410366146 |
| Fax |
|
| Email |
muthu.venky@gmail.com |
|
|
Source of Monetary or Material Support
|
| Psychiatric OPD, Ground floor,
Pradyumna Bal Memorial Hospital, Kalinga Institute Of Medical Sciences,Campus-5,Patia, Bhubaneswar -751024, Odisha ,India |
|
|
Primary Sponsor
|
| Name |
Mrs Sanjukta Dixit |
| Address |
Asst. Professor, Kalinga Institute Of Nursing Sciences, KIIT Deemed to be University, Campus-5, Patia, Bhubaneswar-751024, Odisha, India. |
| Type of Sponsor |
Other [] |
|
|
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 |
| Dr Udit Panda |
Pradymna Bal Memorial Hospital,KIMS |
Psychiatric OPD, Ground floor, PBMH,KIMS ,Campus-5,Patia, Bhubaneswar-751024 ,Odisha .
Khordha
ORISSA |
7978961817
uditpanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee KIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Nurse led intervention
|
The intervention will include sessions on Risk benefit analysis , relapse prevention strategies and coping skill training. which will be delivered in 6 sessions in 6 weeks. Each session will be for 35 mins and will include lecture as well as activity sessions. |
| Comparator Agent |
Treatment as usual |
Standard treatment provided at the OPD |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
The study will include alcohol dependent patients
• willing to participate
• Of age 18 years and above
• scoring less than 12 as assessed by AUDIT
• receiving the session completely |
|
| ExclusionCriteria |
| Details |
The study will exclude alcohol dependent patients who will be having Concurrent presence of other substance dependence, suffering from any significant physical or mental illness requiring intensive medical/surgical management, undergoing any external counselling session and who will not receive the intervention completely.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Depression as assessed by Beck Depression Inventory ,
Craving as assessed by Penn Alcohol Craving Scale. |
2 weeks ,1month and 2months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Withdrawal severity as assessed by Clinical Institute Withdrawal Assessment Alcohol Scale Revised |
2 weeks,1month and 2 months |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
15/01/2026 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is a randomised controlled open-label trial conducted to evaluate the effectiveness of nurse-directed intervention on alcohol, craving and withdrawal severity among alcohol dependent patients availing treatment from the outpatient psychiatric department of PBMH KIMS. 104 participants will be selected according to the eligibility criteria and will be divided into 2 parallel groups. Participants of the experimental group will receive the intervention in 6 sessions , 1 session per week for 35 minutes. The primary outcome measures will be assessment of mean Beck depression score and mean craving score measured at 2 weeks , 1month and 2months by using Beck depression inventory and Penn’s alcohol Craving Scale. The secondary outcome measure will be assessment of withdrawal severity score measured at 2 weeks , 1month and 2months by using Clinical Institute Withdrawal Assessment for Alcohol- Revised . |