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临床试验/NCT01935583
NCT01935583已完成不适用

Intervention to Promote Survivor Resilience and Adjustment: Efficacy Evaluation (a Research Project Within the Traumatic Brain Injury Model System Grant)

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2013年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
164
试验地点
2
主要终点
Connor-Davidson Resilience Scale-10 (CD-RISC-10)

研究概览

简要总结

  1. To evaluate the short and longer-term efficacy of a structured outpatient intervention program (The Resilience and Adjustment Intervention, RAI) to improve survivors' resilience.
  2. To evaluate the impact of treatment on emotional well-being and postinjury adjustment.
  3. To evaluate the impact of the intervention on abilities including problem solving, communication, and stress management.
  4. To examine the extent to which treatment benefits are sustained in the longer-term.

详细描述

To design effective resilience interventions, a treatment modality which is effective for traumatic brain injury (TBI) survivors is needed. Virginia Commonwealth University (VCU) researchers have had considerable success in the past several decades developing and evaluating interventions for neurobehavioral, cognitive, and vocational challenges after TBI. Researchers have demonstrated the utility of the curriculum-based (C-B) treatment structure in various settings. Additionally, the efficacy of the C-B structure, independent of postinjury timeframe, allows the flexibility necessary to address the unique consequences of TBI.

The C-B treatment modality offers a promising strategy for the promotion of resilience postinjury. The primary purpose of the study is to evaluate the efficacy of a structured, curriculum-based intervention to promote postinjury resilience and adjustment. Objectives include:

  1. to evaluate the short and longer-term efficacy of a structured outpatient intervention program (The Resilience and Adjustment Intervention, RAI) to improve survivors' resilience
  2. to evaluate the impact of treatment on emotional well-being and postinjury adjustment
  3. to evaluate the impact of the intervention on abilities including problem solving, communication, and stress management
  4. to examine the extent to which treatment benefits are sustained in the longer-term

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • mild, moderate, or severe TBI
  • able to understand and provide consent

排除标准

  • active substance abusers (e.g., intoxicated at arrival to intake)
  • at imminent risk of psychiatric hospitalization
  • in imminent danger of hurting themselves or others

研究组 & 干预措施

Resilience/Adjustment Counseling

Experimental

Intervention to promote resilience and adjustment (RAI) - The RAI was developed based upon considerable clinical experience and research review. The RAI is a structured approach to helping individuals after brain injury address issues related to resilience and adjustment to injury. The RAI is implemented in seven, 60-minute, in-person sessions.

干预措施: Resilience/Adjustment Counseling (Behavioral)

Waitlist Control

No Intervention

Individuals are randomly assigned to the treatment group or waitlist control (WLC) group. Individuals will complete the study measures on 2 occasions, 5 weeks apart. In fairness, WLC participants will then be offered the opportunity to participate in the intervention.

结局指标

主要结局

Connor-Davidson Resilience Scale-10 (CD-RISC-10)

时间窗: Change from Baseline to Post-Treatment (5 weeks after Baseline)

During the past decade, researchers have developed resilience measurement scales, and a recent review suggested that Connor and Davidson have been most successful. The authors first developed a 25 item scale (CD-RISC) reflecting resilience characteristics identified by Kobasa and Rutter. Normative studies including factor analyses indicated that the CD-RISC is reliable, valid, and sensitive to treatment effects. More recently, a 10-item version was developed using exploratory and confirmatory factors analyses. Respondents are presented with a series of descriptors (e.g., "I am able to adapt and change," "Coping with stress can strengthen me") and rate themselves on a 0 - 4 scale ranging from rarely true (0) to true nearly all the time (4). Campbell-Sills and colleagues have characterized the 10-item version, to be used in the present study, as demonstrating excellent psychometric properties, namely reliability, internal consistency, and construct validity.

次要结局

  • Mayo Portland Adaptability Inventory-4 (MPAI-4)(Change from Baseline to Post-Treatment (5 weeks after Baseline))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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