Re-Inventing Yourself After SCI: A Site-Specific Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Change in Moorong Self-Efficacy Scale (MSES) score over a 30 week time period
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of a replicable, psychologically-based group education intervention, Re-Inventing Yourself after Spinal Cord Injury (SCI), which aims to enhance personal self-efficacy. A structured six-week, manualized, group therapy intervention that delivers positive psychology concepts within a cognitive-behavioral therapy-based model has been created for the purpose of developing a resilient and optimistic sense of efficacy for people with SCI. Concepts covered within this intervention include: reframing and restructuring a person's method of looking at events, building confidence by focusing on personal strengths, developing methods of recognizing and appreciating the good in one's life and expressing gratitude for positive attributes. The goals of this intervention are to increase personal self-efficacy, enhance emotional well-being and improve participation in society for people with SCI living in the community. The investigators hypothesize that persons receiving the intervention will demonstrate improved SCI-specific and overall self-efficacy as compared to waitlist controls.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •History of traumatic SCI at any level;
- •at least 4 weeks post-discharge from initial inpatient rehabilitation;
- •18 years of age or older at the time of study enrollment;
- •English speaking in order to complete study measures and participate in group interactions; and
- •able to provide informed consent to participate
排除标准
- •History of moderate or severe traumatic brain injury;
- •current participation in another RCT;
- •live beyond a reasonable commuting distance from Craig Hospital;
- •unable to verbally communicate;
- •unable to attend group sessions;
- •active participation in another formal clinical group or psychological therapy;
- •are currently experiencing moderately severe or greater levels of depression which would require more intense treatment than is provided in this intervention, as evidenced by a score of 15 or higher on the Personal Health Questionnaire-9;37
- •are currently of high self efficacy, as determined by a score of 90 or higher on the MSES,32 which has a range of 16 to 112, with higher scores representing higher SCI-specific self-efficacy; or
- •have any condition that, in the judgment of the investigators, precludes successful participation in the study.
研究组 & 干预措施
SCI Reinvention Protocol Participants
This group will receive 6 instructor-led 2 hour long didactic presentations regarding 8 key principles of self-efficacy and experiential exercises, including goal setting and problem solving with extensive group discussion. At the end of each session, tasks are assigned to participants to be completed outside the group during the week between sessions. Experiences from these activities and practice implementing the intervention principles will be shared and discussed each week, providing additional opportunities for problem solving and positive feedback.
干预措施: SCI Reinvention Protocol Participants (Behavioral)
Waitlist Group
This group will include individuals randomized to receive no treatment for the 30 weeks during which the interventional group will receive the active treatment and have their progress tracked.
干预措施: Waitlist Group (Other)
结局指标
主要结局
Change in Moorong Self-Efficacy Scale (MSES) score over a 30 week time period
时间窗: Baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
The MSES is a 16 item self-report measure of self-efficacy related to everyday life activities, designed specifically for persons with SCI. Individuals use a 7-point Likert scale ranging from 1 (very uncertain) to 7 (very certain) to rate their ability to perform 16 everyday tasks, with higher scores representing greater perceived self-efficacy.
次要结局
- Change in General Self-Efficacy Scale scores over a 30 week time period(Baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks)