Evaluation of Well-being Interventions in Adults With TBI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Strengths Knowledge and Strengths Use Scale (SKUS)
研究概览
简要总结
The purpose of this research is to evaluate the potential benefits of two Intervention programs in adults with TBI to improve well-being and other outcomes that are maintained over time.
详细描述
The current study will examine the efficacy of Signature Strengths in adults with TBI to improve self-concept and other outcomes that are maintained over time. Preliminary evidence suggests that after a TBI, an individual can experience significant alteration to their personal identity and a perceived loss of their pre-injury self. By using this Signature Strength intervention, adults with moderate to severe TBI will be able to become aware of their most used "signature" strengths, explore how these strengths are used in everyday life, and apply them in future situations to bring well-being and to better cope with stressors.
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 (Participant, 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
- •At least 18 years of age
- •Have a diagnosis with moderate to severe TBI
- •At least one year post injury
- •Able to speak and read English fluently
排除标准
- •Have a history of multiple sclerosis, stroke, seizures or another nervous system injuries disease in the past (like brain tumor or epilepsy)
- •Have a significant psychiatric illness (like, schizophrenia or psychosis)
- •Currently taking steroids and/or benzodiazepines as determined by study staff review of medications
- •Significant alcohol or drug abuse history (requiring inpatient treatment)
- •History of stroke, schizoaffective disorder, bipolar disorder, personality disorder or severe depression determined by extensive screening by a trained staff member
- •Previous participation in a Signature Strengths program
结局指标
主要结局
Strengths Knowledge and Strengths Use Scale (SKUS)
时间窗: Baseline, 3 months posttest, and 6 months posttest
Measure to assess knowledge and use of one's strengths and measure changes following strengths-based interventions. Two scores: Strengths Use and Strengths Knowledge. Strengths Use values range from 14-98, with higher score indicating a better outcome. Strengths Knowledge values range from 8-56, with higher score indicating a better outcome.
Global Assessment of Character Strengths
时间窗: Baseline, 3 months posttest, and 6 months posttest
24-item questionnaire to rate levels of individual's character strengths. Values range from 24-120, with higher score indicating a better outcome.
Rosenberg Self-Esteem Scale (RSES)
时间窗: Baseline, 3 months posttest, and 6 months posttest
Self-report self-esteem questionnaire. Values range from 10-40, with higher score indicating better outcome.
Head Injury Semantic Differential Scale - Version III (HISD-III)
时间窗: Baseline, 3 months posttest, and 6 months posttest
Self-report for examination of past and present self-identity. Values range from 18-126, with higher score indicating a better outcome.
Twenty-Statements Task
时间窗: Baseline, 3 months posttest, and 6 months posttest
20-item questionnaire used to measure an individual's self concept filling out the twenty items that each start with the words "I am..." which will be analyzed for positive and negative valence, with higher score indicating a better outcome. There is no maximum or minimum value for this test.
次要结局
- Satisfaction with Life Scale (SWLS)(Baseline, 3 months posttest, and 6 months posttest)
- Connor-Davidson Resilience Scale 10 (CD-RISC-10)(Baseline, 3 months posttest, and 6 months posttest)
- Flourishing Scale (FS)(Baseline, 3 months posttest, and 6 months posttest)
- Voicemail Elicitation Task(Baseline, 3 months posttest, and 6 months posttest)
- Perceived Stress Scale(Baseline, 3 months posttest, and 6 months posttest)
- Quality of Life After Brain Injury (QOLIBRI)(Baseline, 3 months posttest, and 6 months posttest)
- Positive and Negative Affect Schedule (PANAS)(Baseline, 3 months posttest, and 6 months posttest)
- Brain Injury Self-Efficacy Scale(Baseline, 3 months posttest, and 6 months posttest)