ReInventing Yourself After SCI: A Multi-site Randomized Controlled Trial of an Intervention to Improve Outcomes After Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 入组人数
- 281
- 试验地点
- 3
- 主要终点
- Moorong Self-Efficacy Scale (MSES) - assessing change over time
研究概览
简要总结
The primary goal of this study is to conduct a multi-site RCT to evaluate the replicability and efficacy of the ReInventing Yourself after SCI intervention in improving health and function outcomes for persons with spinal cord injury (SCI). A total of 252 participants will be randomized to one of three research arms: 1) Group treatment plus workbook (Group), 2) individual self-study through YouTube video plus workbook (Indiv), and 3) no treatment, no workbook (Control). Participants randomized to the Group arm will attend 6 virtual weekly group sessions led by a pair of group facilitators and will utilize the study workbook. Indiv arm participants will receive the workbook and will be instructed to independently access YouTube videos of the group session content. Control arm participants will not receive any intervention during the 6 week period. Participants in all three arms will be assessed at identical time points throughout the study: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks, and 46 weeks.
It is hypothesized that individuals in the Group intervention arm will show greater improvements after the six week intervention in SCI-specific and general self-efficacy, emotional well-being, increased societal participation, less depressive and anxiety symptomatology, and improved resilience than participants in the Indiv and Control arms.
详细描述
The purpose of this study is to conduct a multi-site randomized controlled trial (RCT) to evaluate the replicability and efficacy of a structured six-week, manualized, group therapy intervention, ReInventing Yourself after SCI that delivers positive psychology concepts within a cognitive behavioral therapy (CBT)-based model. The goals of this RCT are to increase SCI-specific and general self-efficacy, enhance emotional well-being, and improve participation in society for people with SCI living in the community. Craig Hospital is the lead site for this study, collaborating with the University of Michigan, Ann Arbor, and Kessler Institute for Rehabilitation in New Jersey.
The intervention is delivered through six sessions, each lasting approximately 2 hours. Eight skills are presented over the course of the intervention to address reframing 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. These skills are presented in a specific sequence through a workbook so that participants can gain mastery of introductory concepts before undertaking those that are both more difficult and complex.
The RCT will have three research arms: 1) Group treatment plus workbook (Group), 2) individual self-study through YouTube video plus workbook (Indiv), and 3) no group or individual sessions, no workbook (Control). It is hypothesized that presenting the positive psychotherapy topics in an interactive structured CBT group format while restructuring maladaptive thought processes and providing experiential opportunities to reinforce behavioral change will result in increased self-efficacy, enhanced well-being and improved societal participation. Three specific hypotheses will be tested:
Hypothesis 1 (Primary): Individuals in the Group arm will show greater improvements after the six week intervention in SCI-specific and general self-efficacy, emotional well-being, increased societal participation, less depressive and anxiety symptomatology, and improved resilience than participants in the Indiv and Control arms.
Hypothesis 2 (Secondary): Individuals in the Group arm will maintain greater improvements through 46 weeks post-intervention in SCI-specific self-efficacy than participants in the Indiv and Control arms.
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
- 否
入选标准
- •History of spinal cord injury/disorder (SCI/D) at any neurological level
- •At least 4 weeks post-discharge from initial inpatient rehabilitation
- •English speaking in order to complete study measures and participate in group interactions
- •Access to the internet and a laptop/desktop computer/smartphone with webcam and the ability and willingness to download Zoom software to join a video conference
- •Able to provide informed consent to participate.
排除标准
- •Diagnosed with MS, Lupus, ALS, or Spina Bifida
- •History of moderate or severe traumatic brain injury
- •Current participation in another RCT
- •Unable to verbally communicate
- •Unable to attend group sessions
- •Active participation in another formal clinical group or psychological therapy
- •Currently experiencing moderately severe or greater levels of depressive symptoms which would require more intense treatment than is provided in this intervention, as evidenced by a score of 15 or higher on the PHQ-9
- •Has any medical or psychological condition that, in the judgment of the investigators, precludes successful participation in the study.
研究组 & 干预措施
Group
ReInventing Yourself after SCI structured group CBT and ReInventing Yourself after SCI study-specific workbook
干预措施: ReInventing Yourself after SCI structured group CBT (Behavioral)
Group
ReInventing Yourself after SCI structured group CBT and ReInventing Yourself after SCI study-specific workbook
干预措施: ReInventing Yourself after SCI study-specific workbook (Behavioral)
Indiv
ReInventing Yourself after SCI study-specific workbook and ReInventing Yourself after SCI YouTube videos
干预措施: ReInventing Yourself after SCI study-specific workbook (Behavioral)
Indiv
ReInventing Yourself after SCI study-specific workbook and ReInventing Yourself after SCI YouTube videos
干预措施: ReInventing Yourself after SCI YouTube videos (Behavioral)
Control
No group sessions, no YouTube videos, no workbook
结局指标
主要结局
Moorong Self-Efficacy Scale (MSES) - assessing change over time
时间窗: The MSES will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 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
次要结局
- General Anxiety Disorder 7-item (GAD-7)- assessing change over time(The GAD-7 will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks))
- The Connor-Davidson Resilience Scale (CD-RISC 10) short form- assessing change over time(The CD-RISC 10 will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks))
- Patient Health Questionnaire - 9 (PHQ-9)- assessing change over time(The PHQ-9 will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks))
- Generalized Self-Efficacy Scale (GSES)- assessing change over time(The GSES will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks))
- Participation Assessment with Recombined Tools - Objective (PART-O)- assessing change over time(The PART-O will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks))
- Diener Satisfaction with Life Scale (SWLS)- assessing change over time(The SWLS will be administered at baseline and subsequent follow-up assessments (i.e., 6 weeks, 14 weeks, 22 weeks, 30 weeks, 46 weeks))