Brief Intervention for Substance Misuse Following Moderate or Severe Traumatic Brain Injury (TBI): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Number of alcoholic drinks consumed per week in past month
研究概览
简要总结
This study is investigating one way to improve health and healthy habits after traumatic brain injury (TBI). The primary goal of this study is to determine if a brief intervention accommodated for persons with moderate or severe TBI is effective in reducing alcohol misuse during the year following injury. It is hypothesized that an adapted Screening, Education and Brief Intervention (adapted SBI) will reduce the number of alcoholic drinks consumed per week over the year following discharge from inpatient rehabilitation, in comparison to a Screening and Education Attention Control condition (SEA control).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sustained a TBI, defined as damage to brain tissue caused by external force and evidenced by loss of consciousness, post-traumatic amnesia, skull fracture, or objective neurological findings
- •History of alcohol misuse within the year prior to injury
- •Be at least 18 years old
- •English-speaking
- •Have cleared post-traumatic amnesia
- •Able and willing to provide informed consent
排除标准
- •Language impairments that would preclude participation in interview
- •Has not cleared post-traumatic amnesia before discharge
结局指标
主要结局
Number of alcoholic drinks consumed per week in past month
时间窗: Change from baseline to 12 months post-discharge
Number of drinks will be recorded at baseline, 6, 9, and 12 months. We will be measuring change in the number of drinks consumed of the course of the year, with the primary outcome being measured at the 12 month assessment.
次要结局
- Number of alcoholic drinks consumed per week in the past month(Change from baseline to 6 months post-discharge)
- Frequency of alcohol binges in past month(Change from baseline to 6 months post-discharge)
- Alcohol expectancies(3 months post-discharge)
- Number of facts retained about negative consequences of substance misuse(12 months post-discharge)
- Number of facts retained about negative consequences of alcohol use(6 months post-discharge)
- Number of alcoholic drinks consumed per week during the past month(Change from baseline to 3 months post-discharge)
- Number of alcohol binges in past month(Change from baseline to 3 months post-discharge)
研究者
Jennifer Bogner, PhD, ABPP
Associate Professor
Ohio State University