Expanding Access to mTBI Treatment for Veterans and Service Members With Co-occurring Substance Use
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Neurobehavioral Symptom Inventory (NSI)
研究概览
简要总结
The purpose of this research is to determine whether military veterans and service members with mild traumatic brain injury with and without co-occurring substance use can complete and benefit from integrated interdisciplinary care individualized to their symptoms, goals, and needs.
Participants will complete surveys about substance use and other symptoms at the beginning and end of treatment in an intensive outpatient program and 6 months after discharge.
详细描述
This pragmatic clinical trial will (1) assess treatment retention and treatment outcomes at the completion of interdisciplinary intensive outpatient program (IOP) and at a 6-month follow-up comparing service members and veterans (SM/Vs) with mild traumatic brain injury (mTBI) + substance use (SU) and a TBI -control group; and (2) assess SU-related outcomes at the end of IOP treatment and durability of SU outcomes at 6-months follow-up among SM/Vs with co-occurring SU. Analyses of these key treatment outcomes along with input from lived experience consultants and other key stakeholders, will be used to refine and disseminate a scalable approach to treating individuals with mTBI and co-occurring SU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •At least 18 years of age
- •US military service member or veteran
- •Diagnosis of mild traumatic brain injury (mTBI) and/or repetitive head impact/blast exposures
- •Participating in the SHARE Military Initiative intensive outpatient program
排除标准
- •History of brain injury other than mTBI or progressive neurological disorder
- •Active psychosis
- •Not able to provide consent
结局指标
主要结局
Neurobehavioral Symptom Inventory (NSI)
时间窗: Study enrollment, immediately after the intervention, and at 6 months follow-up
a 22-item, self-report questionnaire used to measure change in symptoms commonly associated with mild traumatic brain injury over time
Short Inventory of Problems- Revised (SIP-R)
时间窗: Study enrollment, immediately after the intervention, and at 6 months follow-up
a 17-item self-report inventory used to assess adverse consequences of substance use
次要结局
- Life-Satisfaction Questionnaire -11 (LISAT-11)(Study enrollment, immediately after the intervention, and at 6 months follow-up)
- Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)(Study enrollment, immediately after the intervention, and at 6 months follow-up)
- Patient Health Questionnaire (PHQ-8)(Study enrollment, immediately after the intervention, and at 6 months follow-up)
- Generalized Anxiety Disorder Scale (GAD-7)(Study enrollment, immediately after the intervention, and at 6 months follow-up)
- Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS Update)(Study enrollment and immediately after the intervention)
- Sensory Organization Test (SOT)(Study enrollment and immediately after the intervention)
- Behavior Rating Inventory of Executive Functioning - Adult Version (BRIEF-A)(Study enrollment and immediately after the intervention)
- Alcohol Use Disorders Identification Test- Concise (AUDIT-C)(Study enrollment and at 6 months follow-up)
- Drug Abuse Screening Test (DAST-10)(Study enrollment and at 6 months follow-up)
- Cannabis Use Disorder Identification Test (CUDIT-R)(Study enrollment and at 6 months follow-up)
- National Survey on Drug Use and Health (NSDUH)- 30-day use: Alcohol and Substances(Study enrollment, immediately after the intervention, and at 6 months follow-up)