| CTRI Number |
CTRI/2022/03/041523 [Registered on: 31/03/2022] Trial Registered Prospectively |
| Last Modified On: |
20/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of Mindfulness on relapsing factors like craving and emotion regulation, in patients with Alcohol Dependence Syndrome |
|
Scientific Title of Study
|
Efficacy of Mindfulness Based Relapse Prevention on Craving and Emotion Regulation in patient with Alcohol Dependence Syndrome
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Riya |
| Designation |
Ph.D. Research Scholar |
| Affiliation |
Shree Guru Gobind Singh Tricentenary University |
| Address |
Department of Clinical Psychology Faculty of Behavioural Sciences, SGT University, Gurgaon
Gurgaon
HARYANA
122505
India |
| Phone |
7739030309 |
| Fax |
|
| Email |
riyamandal88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Riya |
| Designation |
Ph.D. Research Scholar |
| Affiliation |
Shree Guru Gobind Singh Tricentenary University |
| Address |
Department of Clinical Psychology Faculty of Behavioural Sciences, SGT University, Gurgaon
Gurgaon
HARYANA
122505
India |
| Phone |
7739030309 |
| Fax |
|
| Email |
riyamandal88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandha Kumar Pujam S |
| Designation |
Associate Professor and Head |
| Affiliation |
Shree Guru Gobind Singh Tricentenary University |
| Address |
Department of Clinical Psychology Faculty of Behavioural Sciences, SGT University, Gurgaon
Gurgaon
HARYANA
122505
India |
| Phone |
9791102586 |
| Fax |
|
| Email |
nandhakumara2008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Clinical Psychology, Faculty of Behavioural Sciences, SGT University, Gurgaon, Haryana |
|
|
Primary Sponsor
|
| Name |
Ms Riya |
| Address |
Department of Clinical Psychology, Faculty of Behavioural Sciences, SGT University, Gurgaon, Haryana |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Nandha Kumara Pujam S |
Department of Clinical Psychology, Faculty of Behavioural Sciences, SGT University, Gurgaon, Haryana |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ms Riya |
SGT University |
Department of Clinical Psychology, Faculty of Behavioural Sciences, SGT University Gurgaon, Haryana
Gurgaon
HARYANA |
7739030309
riyamandal88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Comittee, Faculty of Behavioral Sciences, SGT University, Gurgaon, Haryana |
Approved |
|
|
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 |
| Intervention |
Mindfulness-Based Relapse Prevention |
Mindfulness-Based Relapse Prevention is the psychotherapy of eight sessions incorporating "mindfulness" methods with relapse prevention techniques. |
| Intervention |
Motivational Enhancement Therapy |
Motivational Enhancement Therapy is a four-session therapy that includes techniques associated with Motivational Interviewing. |
| Comparator Agent |
Treatment As Usual |
It is the treatment that is provided in the centre of all Addiction patient as part of treatment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Male |
| Details |
Those who fulfill the ICD-10 criteria of Alcohol dependence.
Those who score above the cutoff on AUDIT.
Those who will give informed consent.
Those educated up to Std 5th. |
|
| ExclusionCriteria |
| Details |
1. Those who do not fulfill the ICD-10 criteria of
Alcohol dependence
2. Those who score below the cutoff on AUDIT.
3. Any other psychoactive substance (except for
Caffeine and Nicotine).
4. Currently having psychosis, organic condition, imminent suicide risk.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A significant change in Mindfulness, Craving, Emotion Regulation and Readiness for Change |
after 12 session |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A significant change in Mindfulness, Craving, Emotion Regulation |
after 8 session |
| A significant change in Readiness for Change |
after 4 sessions |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2022 |
| Date of Study Completion (India) |
19/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet |
|
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 randomized controlled comparative, Between-group design with pre-and post-treatment comparison with 12 sessions of psychotherapy. A total of 100 participants diagnosed with Alcohol dependence Syndrome will be obtained, 50 of them will be randomly assigned to the experimental group and 50 will be randomly assigned to the control group. The participants in the experimental group will initially receive four individual sessions of Motivational Enhancement Therapy held twice weekly for 1 hour and then they will be randomly assigned in the group sessions of Mindfulness-Based Relapse Prevention Therapy held weekly once for 2 hours each. The effect of psychotherapy will be assessed after 4 sessions, 8 sessions, and 12 sessions. The primary outcome measure is a significant difference in Mindfulness, Craving, Emotion Regulation, and Readiness for change after 12 sessions. |