Cognitive Behavioral Therapy (CBT) for Caregivers of Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Service Members With Combat-Related Traumatic Brain Injuries (TBI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire-9
研究概览
简要总结
The primary purpose of this research is to evaluate the impact of a telehealth-based, cognitive behavioral therapy (CBT) intervention (problem-solving training: PST) for adult informal military family/friend caregivers of OIF/OEF service members with a deployment-related TBI.
详细描述
Traumatic brain injury (TBI) has gained increasing attention in American society as it is now considered the "signature injury" of the Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) campaigns. The chronic changes that often occur in the wake of TBI along with possible physical injuries may run a chronic, unremitting course, imposing great strain and distress upon family members who often assume a caregiver role with little preparation and no formal training for these wounded service members as they reintegrate back into civilian life post-deployment. Unfortunately, research has not adequately addressed the unique long-term needs of informal military caregivers of deployed service members with TBI (i.e., family members/close friends).
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 (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 19 years old
- •Meets study project definition of a military caregiver
- •Documentation or determination of an OIF/OEF deployment related TBI
- •Service member will have presented to a Veterans Administration Medical Center (VAMC) or military medical center
- •English-speaking
- •Has access to a telephone for the administration of measures and/or intervention calls
- •Has no significant cognitive or communication problems that might significantly interfere with adequately understanding information or talking on the telephone which will be determined by the clinical judgment of the person consenting the participant.
排除标准
- •Has a life-threatening or other serious disease that impacts the ability to participate for the duration of the project
- •No determination or documentation of a deployment-related TBI related to OIF/OEF for the injured service member
- •Has a severe hearing impairment that impedes communication and standardized implementation of the intervention and telephone follow-up
- •Formal caregiver
- •Caregiver does not want to participate
结局指标
主要结局
Patient Health Questionnaire-9
时间窗: Change from baseline in PHQ-9 scores at post-program (3-months follow-up)
次要结局
未报告次要终点
研究者
Laura E. Dreer, PhD
Assistant Professor
University of Alabama at Birmingham