A Randomized Controlled Trial of an Online Emotion Regulation Intervention Following TBI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- Difficulties in Emotion Regulation Scale (DERS)
研究概览
简要总结
This study will examine the efficacy of an emotion regulation intervention delivered online to individuals with traumatic brain injury (TBI) with deficits in emotion regulation. 104 subjects will be enrolled and will receive 24, 60-minute emotion regulation skills-training sessions twice a week for 12 weeks, delivered online in a group video-conference with 3-5 other participants. Participants will be asked to complete online surveys, lasting approximately 40-50 minutes, every four weeks during the intervention and the 12-week follow-up phase. Attendance and compliance will be tracked, and outcomes will be monitored using online data collection methods.
详细描述
This study will assess the efficacy of an emotion regulation skills-training intervention (Online EmReg) provided online to individuals with TBI with emotion regulation difficulties. Specifically, this study seeks to accomplish three aims: 1) Evaluate the efficacy of the Online EmReg intervention immediately post-intervention and at a 12-week follow-up assessment; 2) Identify factors that optimize the effectiveness of the Online EmReg intervention; 3) Explore the impact of Online EmReg on positive and negative affect, life satisfaction, and executive functioning. The study design is a randomized control trial with a waitlist control group whereby the participants in the control group undergo the training after a 12 week waiting period. 104 subjects with TBI and self-reported deficits in emotion regulation will be enrolled.
The intervention protocol calls for 24, 60-minute emotion regulation sessions twice a week for 12 weeks, delivered online via Zoom by post-doctoral level therapists with specialty training in rehabilitation neuropsychology. Study participation will last approximately 28 weeks for participants in the immediate intervention arm (4 weeks preparation, 12 weeks intervention, 12 weeks follow-up) and 40 weeks for participants in the waitlist arm (4 weeks preparation, 12 weeks waitlist, 12 weeks intervention, and 12 weeks follow-up). Core assessments will be conducted at each major time point: T1 (baseline), T2 (immediate intervention end/waitlist baseline), T3 (immediate intervention follow-up/end of waitlist intervention), and T4 (waitlist follow-up). A subset of the measures will be administered every 4 weeks between each major time point for the duration of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •medically documented mild to severe TBI
- •at least 6 months post-injury
- •deficits in emotional regulation (ER), operationalized as a score of 0.5 standard deviations above published means on the Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
- •English speaking
- •adequate communication skills, assessed by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)
- •access to and ability to use a device that supports GoToMeeting/Zoom, the videoconference software
- •active email address
- •access to the Internet with adequate broadband
- •Lives in the following states for the duration of the 12-week intervention: New York, California, Maryland, North Carolina, Georgia, Missouri, Arizona, New Jersey, Colorado, Florida, or Washington DC
排除标准
- •current alcohol or substance abuse
- •current psychotic disorder, mood disorder with psychotic features or current suicidality, assessed by the Mini International Neuropsychiatric Interview
结局指标
主要结局
Difficulties in Emotion Regulation Scale (DERS)
时间窗: Every 4 weeks for 28 or 40 weeks
36-item self-report questionnaire that focuses on emotional awareness, acceptance, ability to control impulsivity, and flexible use of strategies.
次要结局
- Dysexecutive Functioning Questionnaire (DEX)(Every 4 weeks for 28 or 40 weeks)
- Satisfaction with Life Scale (SWLS)(Every 4 weeks for 28 or 40 weeks)
- Skill Acquisition Quiz (SAQ)(End of intervention (at 16 or 28 weeks) and follow-up at 12-weeks post intervention)
- Positive Affect Negative Affect Schedule (PANAS)(Every 4 weeks for 28 or 40 weeks)
- Problem Solving Inventory (PSI)(Every 4 weeks for 28 or 40 weeks)
- Transition Ratings (TR)(End of intervention (at 16 or 28 weeks) and follow-up at 12-weeks post intervention)
- Progress Toward Goals (PTG)(Every 4 weeks for 28 weeks)
研究者
Kristen Dams-O'Connor
Professor, Rehabilitation Medicine
Icahn School of Medicine at Mount Sinai