A Randomized Controlled Trial to Evaluate the Efficacy of Inhibitory Control Training for Aggressive Behaviours among Individuals with Co-occurring Substance Use Disorder and Gambling Behaviour
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Score on the Overt Aggression Scale – Modified (OAS-M).
研究概览
简要总结
This study is a randomized controlled trial (RCT) investigating the efficacy of Inhibitory Control Training compared to Sham Training in reducing aggression among individuals with co-occurring substance use disorder and gambling behavior. The trial employs a two-group, parallel design and evaluates participants at four time points: pre-intervention, post-intervention (1 day, 1 month, and 3 months). The primary outcome measure is the frequency and intensity of aggressive behaviors reported one month after the intervention, assessed using the Overt Aggression Scale – Modified. Secondary outcomes include scores on the Overt Aggression Scale at the three-month follow-up, substance use assessed by the Timeline Follow Back Scale, and gambling behavior measured by the South Oaks Gambling Scale, both at 1-Month Follow Up and 3-Month Follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Patients seeking treatment from the Inpatient Department (IPD) at NDDTC, AIIMS.
- •2.Male Patients.
- •3.Patients diagnosed with substance use disorder in accordance with DSM-5, as per clinical history.
- •4.Patients qualifying the criteria of problem or pathological gambling in accordance with the score on South Oaks Gambling Screen (SOGS).
- •A score of 1 to 4 suggests problem gambling while score of more than 4 indicates probable pathological gambling.
- •5.Patients must be willing to participate in the study.
- •6.Patients willing to attend follow-ups.
排除标准
- •1.Patients with severe medical/ psychiatric illnesses that preclude their participation in the study, as per clinical history.
- •2.Patients with a lifetime history of a neurological illness, neurodevelopmental disorder, or traumatic head injury as per clinical history.
- •3.Patients not willing to participate or provide informed consent for the study.
结局指标
主要结局
Score on the Overt Aggression Scale – Modified (OAS-M).
时间窗: At 1 Month Follow Up.
次要结局
- Score on the Overt Aggression Scale – Modified (OAS-M)(At 3 Months Follow Up)
- Score on the Timeline Follow Back Scale for each substance used(At 1 Month Follow Up and 3 Months Follow Up)
- Score on the South Oaks Gambling Scale (Item – 1) for each type of gambling behaviour engaged in(At 1 Month Follow Up and 3 Months Follow Up)
研究者
Yashita Ahluwalia
All India Institute of Medical Sciences (AIIMS), New Delhi