Development of a Comprehensive Self-Regulation Intervention for Individuals with Alcohol Dependence Syndrome
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •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-
- •Individuals who will give informed consent for the study.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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.)
研究者
Sarnajeet Das
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health (LGBRIMH), Tezpur, Assam