Comparison of Two Group Wellness Interventions in Partner Caregivers of Individuals With Traumatic Brain Injury: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Change on Behavioral Inhibition Scale (BIS)
研究概览
简要总结
The purpose of this research study is to compare the effect of two different types of group wellness interventions for partner caregivers of individuals with traumatic brain injury (TBI). The study is designed to evaluate how well these treatments can help TBI partner caregivers improve approach/avoidance behaviors.
详细描述
A multi-site randomized controlled trial will be conducted to evaluate the effectiveness of two different types of group wellness interventions for partner caregivers of individuals with traumatic brain injury (TBI). 92 participants will be recruited. Participants are randomly assigned to one of two wellness groups. Each group will involve six weekly 75-minute live video conference sessions as well as independent homework assignments that will be discussed in closed social media forums with peers and facilitators. Participants will complete self-report measures (approach and avoidance, anxiety, depression, caregiver appraisal, resilience, self efficacy, social integration, quality of life.) prior to intervention participation, within a week of class 6, and at 3-months post-intervention.. Intervention effectiveness will be determined by improvements between baseline and follow-up on a self-report measure of approach/avoidance behaviors.
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
- Triple (Participant, Investigator, 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
- •at least 18 years of age.
- •read and speak English fluently.
- •have been in an intimate relationship with a person with TBI for at least one year prior to their injury.
- •partner was discharged from inpatient rehabilitation at least 3 months ago.
- •provide care to partner on a daily basis.
- •have access to the internet in a private location.
排除标准
- 未提供
结局指标
主要结局
Change on Behavioral Inhibition Scale (BIS)
时间窗: 6 weeks (between pre- and post testing)
The BIS measures avoidance of aversive stimuli (e.g., anxiety, fear worry)
Change on Behavioral Activation Scale (BAS)
时间窗: 6 weeks (between pre- and post testing)
The BAS measures responsiveness to goals, fun, and rewarding stimuli.
次要结局
未报告次要终点
研究者
Denise Krch
Senior Research Scientist
Kessler Foundation