| CTRI Number |
CTRI/2024/05/067577 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Developmental of Psychotherapeutic module of Self Regulation in patients with ADS] |
| Study Design |
Other |
|
Public Title of Study
|
Role of Self-Regulation Strategies for Individuals with Alcohol Dependence Syndrome |
|
Scientific Title of Study
|
Development of a Comprehensive Self-Regulation Intervention for Individuals with Alcohol Dependence Syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarnajeet Das |
| Designation |
PhD Scholar, Department of Clinical Psychology |
| Affiliation |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health (LGBRIMH), Tezpur, Assam |
| Address |
Department of Clinical Psychology, Academic Building, 5th floor, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health (LGBRIMH), Tezpur, Assam
Sonitpur
ASSAM
784001
India |
| Phone |
9706793463 |
| Fax |
|
| Email |
sarnajeetdas95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas |
| Designation |
Assistant Professor |
| Affiliation |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health (LGBRIMH), Tezpur, Assam |
| Address |
Department of Clinical Psychology, Academic Building, 5th floor, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health (LGBRIMH), Tezpur, Assam
Sonitpur
ASSAM
784001
India |
| Phone |
09992144462 |
| Fax |
|
| Email |
vikas85punia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikas |
| Designation |
Assistant Professor |
| Affiliation |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health (LGBRIMH), Tezpur, Assam |
| Address |
Department of Clinical Psychology, Academic Building, 5th floor, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health (LGBRIMH), Tezpur, Assam
Sonitpur
ASSAM
784001
India |
| Phone |
09992144462 |
| Fax |
|
| Email |
vikas85punia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Addiction Medicine and Department of Clinical Psychology, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health (LGBRIMH), Tezpur, Assam |
| Sarnajeet Das |
|
|
Primary Sponsor
|
| Name |
Sarnajeet Das |
| Address |
Department of Clinical Psychology, Academic Building, 5th Floor, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health (LGBRIMH), Tezpur, Assam |
| 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 |
| Sarnajeet Das |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health (LGBRIMH) |
Room no 5, Department of Addiction Medicine, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health (LGBRIMH), Tezpur, Assam, Pin-784001
Sonitpur
ASSAM |
9706793463
sarnajeetdas95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal controls not using any kind of psychoactive substance which is causing any kind of cognitive, behavioral and physiological symptoms and affecting their daily functioning. |
| Patients |
(1) ICD-10 Condition: G||Mental Health, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Self Regulation Intervention |
Assessment will be done before intervention and post intervention and on follow up visit after 2 months |
| Comparator Agent |
Self Regulation Intervention |
Comparison will be done based on the assessment post intervention and on follow up visit after 2 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for individual with ADS: Individual diagnosed with Alcohol Dependence Syndrome as per ICD-10
Individual between age group of 18 years to 45 years of age
Individuals who can read Assamese or English.
Individual who will give informed consent for the study
Inclusion criteria for Normal Controls:
Individuals between age group of 18 years to 45 years of age
Individuals who can read Assamese or English.
Individual score less than 20 on K-10.
Individuals who will give informed consent for the study. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria for individual with ADS:
Individuals have dependence on any other psychoactive substance except nicotine and tobacco dependence.
Individual having dual psychiatric diagnosis
Individual who has history of complicated withdrawal seizure
Individual who has gone through any form of psychotherapy within the last 1 month.
Exclusion criteria for normal controls:
Individuals using any psychoactive substances on a regular basis.
Individuals with a history of psychiatric illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The present research will help in the development of a comprehensive model of Self-Regulation. It will also help to understand the factors contributing to the broader concept of Self Regulation in Alcohol Dependence Syndrome. The proposed Self Regulation intervention will help in elevating Self Regulation and thereby abstinence in Alcohol Dependence Syndrome. |
The study will be conducted in two phase. In phase one individuals with Alcohol Dependence Syndrome (ADS) and normal controls will be assessed on selected tools and based on the findings of the phase one, a self regulation intervention module will be developed. In phase two the developed intervention module will be tested for feasibility on 8 individuals. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Self Regulation intervention will help in elevating Self Regulation and thereby abstinence in Alcohol Dependence Syndrome. |
The study will be conducted in two phase. In phase one individuals with Alcohol Dependence Syndrome (ADS) and normal controls will be assessed on selected tools and based on the findings of the phase one, a self regulation intervention module will be developed. In phase two the developed intervention module will be tested for feasibility on 8 individuals. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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/ Phase 2 |
|
Date of First Enrollment (India)
|
30/05/2024 |
| 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="2"
Months="3"
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
|
Background of the study: Self-Regulation (SR) is theorized to play an important role in substance use disorders (SUDs) in terms of its development, maintenance, and recovery from it. SR involves the effort to consciously overcome ingrained drug use behaviors or habits in order to achieve positive and lasting results (Ross et. al., 2020). Existing literature showed evidence that SR plays a significant role in alcohol use disorder. Aim & objectives: The aim of the present study is to develop a comprehensive SR intervention for individual with alcohol dependence syndrome. The specific objectives of the study are to study mindfulness, emotion regulation and executive functions as correlates of SR among individuals with Alcohol Dependence Syndrome (ADS); to develop a comprehensive SR intervention for individuals with ADS; to compare SR and its correlates before and after SR intervention among individuals with ADS and to examine the effect of SR interventions on relapse among individuals with ADS. Need of the Study: Studies are mostly found to be limited to the Western context and found to be less explored in Indian context. Studies are lacking to explore how the various important components of SR predict SR as a whole and thereby abstinence in SUDs. Hence the present study is an attempt to explore different components in SR as a construct. Methodology: It will be a quantitative study with a cross-sectional design, where in the first phase 110 individuals with ADS, attending Psychiatry IPD/OPD will be included after applying inclusion and exclusion criteria along with 40 numbers of normal controls matched on age and education with individuals with ADS. Subsequently, in phase two based on the findings of the statistical analysis a comprehensive SR module will be prepared and will be validated using Delphi method. The proposed intervention will be tested on 6 individuals with ADS with pre, post intervention and after 2 months follow up. Individuals will be assessed using the constructs which will define SR. Tools to be applied: A semi-structured socio-demographic and clinical data sheet, Kessler Psychological Distress Scale (K10) (Kessler, 1996) (for normal controls only); AUDIT-10 (WHO, 1992) and Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) (Miller & Tonigan, 1996) (for ADS group only) will be used for initial screening. Thereafter both the groups will be assessed using Mindful Attention Awareness Scale (MAAS) (Brown & Ryan 2003), Five Facet Mindfulness Questionnaire (FFMQ) (Baer et al. 2006), Emotion Regulation Questionnaire (ERQ) (Gross & John, 2003), Short Form Self-Regulation Questionnaire (SSRQ) (Brown et al., 1999), Impulsive Sensation Seeking Scale from ZKPQ (Zuckerman et al., 1993), Wisconsin Card Sorting Test (Milner, 1963), Alcohol Related Stroop Task and Semi structured SR scale for Alcohol Dependence Syndrome. |