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临床试验/NCT05851573
NCT05851573已完成不适用

Stepped Care Model of Psychological Care for Aphasia

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2023年3月31日最近更新:
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
11
试验地点
2
主要终点
Change in the Depression Score on Hospital Anxiety and Depression Scale at Post-Intervention

研究概览

简要总结

This study is recruiting people who had a stroke at least 1 month ago and now have a language impairment called aphasia. Living with aphasia can have devastating effects on communication and quality of life, and it is not uncommon for survivors with aphasia to face psychological problems like depression and anxiety. Participants who are eligible for this study will undergo baseline testing, engage in a 5-week treatment focused on psychological well-being, undergo post-treatment testing, and then testing again 1-month later. Check-in phone calls will be conducted during the 1-month off period and participants will be interviewed about their experience at the end of the study as well. Compensation will be provided to participants with aphasia.

研究设计

研究类型
Interventional
分配方式
Na
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 81 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-81 years old
  • Native English speaker (English fluency by age 7)
  • Aphasia as a result of a left-hemisphere ischemic or hemorrhagic stroke (WAB-R Aphasia Quotient < 93.8)
  • At least 1-month post-stroke
  • Confirmation of left hemisphere stroke per medical records
  • Discharged from hospital
  • Participant is willing and able to consent for themselves.

排除标准

  • Uncorrected hearing or visual impairment that prevents completion of experimental activities as determined by self-report
  • History of other neurological disorder or disease beside stroke (e.g., dementia, traumatic brain injury) as determined by self-report and/or medical records
  • Self-reported history of premorbid learning disability
  • Severe auditory comprehension deficits (as indicated by a score of more than two standard deviations below norms on the Auditory Verbal section of WAB-R)

研究组 & 干预措施

Psychosocial intervention

Experimental

干预措施: Psychosocial intervention (Behavioral)

结局指标

主要结局

Change in the Depression Score on Hospital Anxiety and Depression Scale at Post-Intervention

时间窗: through intervention completion, an average of 7 weeks

Change in the total depression Hospital Anxiety and Depression Scale scores between baseline and post-treatment (baseline-post-treatment). Minimum score 0, maximum score 21. Positive scores indicate an improvement in symptoms, negative scores indicate a worsening in symptoms.

Change in the Anxiety Score on Hospital Anxiety and Depression Scale at Post-Intervention

时间窗: through intervention completion, an average of 7 weeks

Change in the total anxiety Hospital Anxiety and Depression Scale scores between baseline and post-treatment (baseline-post-treatment). Minimum score 0, maximum score 21. Positive scores indicate an improvement in symptoms, negative scores indicate a worsening in symptoms.

次要结局

  • Change in Dynamic Visual Analogue Mood Scales at Post-Intervention(through study completion, an average of 7 weeks)
  • Change in Stroke Aphasia Depression Questionnaire - 10 at Post-Intervention(through intervention completion, an average of 7 weeks)
  • Change in Behavioural Outcomes of Anxiety Scale at Post-Intervention(through intervention completion, an average of 7 weeks)
  • Change in Modified Perceived Stress Scale at Post-Intervention(through intervention completion, an average of 7 weeks)
  • Change in Stroke Aphasia Quality of Life - 39 at Post-Intervention(through intervention completion, an average of 7 weeks)
  • Change in Communication Confidence Rating Scale for Aphasia at Post-Intervention(through intervention completion, an average of 7 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Deena Blackett

Principal Investigator

Medical University of South Carolina

研究点 (2)

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