3i Model Vethathirian Contemplative Talk-less Therapy of Simplified Kundalini Yoga in Tobacco Cessation Among Adult Men With Alcohol Dependence
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. To assess and compare the change in tobacco use in:
研究概览
简要总结
This study aims to evaluate the effectiveness and feasibility of a two-phase intervention model for addiction rehabilitation. The first phase involves 3i model of Talkless Therapy comprised of inner travel meditation, inner silence and introspection, followed by standard psychotherapy. The primary objectives are to assess the additive or alternative impact of this staged approach on motivation for abstinence, emotional regulation, and craving reduction. Secondary objectives include examining participant adherence and acceptability of the protocol, as well as exploring the feasibility of integrating 3i as an alternative or adjunct to standard care in rehabilitation settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Male
入选标准
- •(1) Males aged 18 years and above (2) Tobacco users with alcohol dependence (ICD-10 diagnosis) (3) Willingness to participate and give informed consent.
排除标准
- •1.Severe psychiatric illness (e.g., psychosis, severe depression with suicidality, bipolar disorder) 2.Serious systemic illness (e.g., decompensated liver disease, uncontrolled hypertension, cardiovascular instability, severe COPD/asthma) 3.Women (pregnant or non-pregnant) 4.Individuals currently enrolled in another cessation program or clinical trial 5.Cognitively impaired individuals unable to understand study procedures.
结局指标
主要结局
1. To assess and compare the change in tobacco use in:
时间窗: At the end of 4th, 8th and 12 th weeks
o Group A: receiving pharmacotherapy and psychotherapy for 8 weeks
时间窗: At the end of 4th, 8th and 12 th weeks
o Group B: receiving pharmacotherapy with 3i Vethathirian Talkless Therapy (first 4 weeks) followed by psychotherapy (next 4 weeks)
时间窗: At the end of 4th, 8th and 12 th weeks
2. To verify behavioural outcomes using biochemical markers:
时间窗: At the end of 4th, 8th and 12 th weeks
o Urinary/salivary cotinine strips for tobacco cessation
时间窗: At the end of 4th, 8th and 12 th weeks
o CO breath analyser for smoking status
时间窗: At the end of 4th, 8th and 12 th weeks
o uEtG (Urinary Ethyl Glucuronide) strips for alcohol abstinence
时间窗: At the end of 4th, 8th and 12 th weeks
3. To evaluate withdrawal symptoms using the CIWA-Ar scale and compare symptom reduction between the groups at Week 4 and Week 8.
时间窗: At the end of 4th, 8th and 12 th weeks
次要结局
- 1. To examine the additive effect of staged intervention (3i followed by psychotherapy) on:(o Motivation for abstinence)
研究者
Meena priya
JKKN Dental College & Hospital