Effectiveness of 5 As based Brief Intervention in Smokeless Tobacco dependence among patients with Common Mental Disorders: A Randomized open-label trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Primary outcome: Self-reported complete abstinence from SLT at the end of six weeks
研究概览
简要总结
Background: Smokeless tobacco (SLT) use is a critical public health issue in India, particularly in the Northeastern states where its prevalence exceeds the national average. SLT contributes to severe health problems, including oral cancers, cardiovascular diseases, and adverse pregnancy outcomes. Despite these risks, SLT cessation interventions are limited, especially in resource-constrained settings like Northeast India. Compounding this issue is the high burden of Common Mental Disorders (CMDs) in India, which include mood, neurotic, stress-related, and somatoform disorders. Individuals with CMDs often engage in substance use, including SLT, as a means of self-medication for symptoms such as anxiety and low mood. Primary Objective: To determine the effectiveness of 5 A’s based Brief Intervention in cessation of smokeless tobacco in patients diagnosed with common mental disorders. Secondary Objectives: (i) To determine prevalence and pattern of smokeless tobacco use in patients with common mental disorders. (ii) To assess changes in SLT consumption patterns after intervention. (iii) To assess the temporal relation between SLT consumption and mental disorder symptoms after intervention. (iv) To determine the effectiveness of 5As in NRT uptake. Methodology: Proposed study is a randomized controlled trial in the setting of Out Patient Department of LGBRIMH, with a sample size of 118 participants. Patients diagnosed with Common Mental Disorders (CMD) will be recruited according to the selection criteria, and severity of SLT consumption will be assessed by Fagerstrom Test for Nicotine Dependence - Smokeless Tobacco (FTND-ST) score, along with severity of mental disorder symptoms using PHQ-9, GAD-7 and PHQ-15 scales. They will be randomized to either the intervention (5A’s brief intervention with Nicotine Replacement Therapy) group (n = 59) or the waitlist control group (n = 59), and followed up at 2 weeks and 6 weeks for medication adherence, partial/complete abstinence from SLT, and symptom reduction. Statistical Analysis: Chi-square test will be used to compare the complete and partial abstinence rates between the two groups, paired t-tests to assess within-group FTND-ST score reduction, and independent t-tests to compare between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing to participate in the study with a written consent
- •Patients using SLT in dependence pattern (as determined by FTND-ST score 3 or more)
- •Patients diagnosed with common mental disorders (CMDs) – depression, anxiety, stress-related and somatoform disorders (diagnosed by ICD-10).
排除标准
- •Patients also consuming tobacco in smoking form having FTND score more than/equal to 3
- •Any patient with a diagnosis of obsessive-compulsive disorder (F42) or Severe Depressive Episode (F32.2 and F32.3) will be excluded from the study.
- •Patients with substance dependence other than tobacco
- •Patients with severe mental illness (SMI) (conditions outside the defined CMD scope (e.g., psychotic disorders, Bipolar mood disorder, Dementia or substance dependence other than tobacco) or severe physical illness who are not amenable for interview will also be excluded.
- •Patients who are receiving Medications like Bupropion/ Nortriptyline for their CMD.
- •Patients whose circumstances might contra-indicate NRT use, such as pregnancy and/ or breastfeeding women.
结局指标
主要结局
Primary outcome: Self-reported complete abstinence from SLT at the end of six weeks
时间窗: 6 weeks
次要结局
- Secondary outcome:(1. Self-reported Partial abstinence: At least 50% reduction in SLT use.)
研究者
Nivedita Mondal
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health