A Bridge From Rehabilitation to Real-World: Re-Inventing Yourself After SCI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Change in Moorong Self-Efficacy Scale (MSES)
研究概览
简要总结
The goal of this randomized controlled trial is to determine the efficacy of a treatment to improve resilience to stress for individuals with SCI who are transitioning from inpatient rehabilitation to home. The overarching hypothesis is that individuals who participate in an intervention that presents positive psychotherapy topics in an interactive, structured, cognitive-behaviorally-based group intervention that stresses restructuring maladaptive thought processes and provides experiential opportunities to reinforce behavioral change will demonstrate increased self-efficacy.
详细描述
The goal of this randomized controlled trial is to determine the efficacy of a treatment to improve resilience to stress for individuals with SCI who are transitioning from inpatient rehabilitation to home. The overarching hypothesis is that individuals who participate in an intervention that presents positive psychotherapy topics in an interactive, structured, cognitive-behaviorally-based group intervention that stresses restructuring maladaptive thought processes and provides experiential opportunities to reinforce behavioral change will demonstrate increased self-efficacy. There were three aims of this study: AIM 1: Self-Efficacy - To examine the ability of a six-week, manualized, cognitive-behaviorally based group educational intervention (Re-Inventing Yourself after SCI-Bridge) to improve both SCI-specific and general self-efficacy for people who are early in the process of community reintegration; AIM 2: Psychosocial Adjustment - To assess the ability of the Re-Inventing Yourself after SCI-Bridge intervention to improve psychosocial adjustment of people with SCI who are early in the community reintegration process; and, Aim 3: Participation - To determine the ability of the Re-Inventing Yourself after SCI-Bridge intervention to improve societal participation for people with SCI who are early in the community reintegration process.
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 (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
- 是
入选标准
- •History of SCI at any level;
- •completed initial inpatient rehabilitation but are no more than 6 months post-discharge;
- •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 severe depression which would require more intense treatment than is provided in this intervention, as evidenced by a score of 20 or higher on the Personal Health Questionnaire-9;
- •report any current suicidal ideation on the Personal Health Questionnaire-9; or
- •have any condition that, in the judgment of the investigators, precludes successful participation in the study.
研究组 & 干预措施
Treatment
Re-Inventing Yourself after SCI protocol - 6-week educational sessions
干预措施: ReInventing Yourself after SCI (Behavioral)
Control
No intervention during course of study; participants offered the option of receiving the study intervention after completion of study.
结局指标
主要结局
Change in Moorong Self-Efficacy Scale (MSES)
时间窗: Baseline, 6 weeks, 12 weeks, 18 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. A Total Score, ranging from 16 to 112 is calculated by summing all item responses. The MSES has been used in previous studies of SCI, and demonstrates excellent internal consistency (alpha = 0.91 - 0.93), high reliability, and good convergent, concurrent and divergent validity. Time to administer: 5 to 10 minutes.
次要结局
- Change in Generalized Self-Efficacy Scale (GSES)(Baseline, 6 weeks, 12 weeks, 18 weeks)
- Change in Participation Assessment with Recombined Tools - Objective (PART-O)(Baseline, 6 weeks, 12 weeks, 18 weeks)
- Patient Health Questionnaire - 9 (PHQ-9)(Baseline, 6 weeks, 12 weeks, 18 weeks)
- Change in General Anxiety Disorder 7-item (GAD-7)(Baseline, 6 weeks, 12 weeks, 18 weeks)
- Change in Satisfaction with Life Scale (SWLS)(Baseline, 6 weeks, 12 weeks, 18 weeks)
研究者
Jennifer Coker
Research Associate
Craig Hospital