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临床试验/NCT03543111
NCT03543111已完成不适用

Promoting the Psychological Health of Women With SCI: A Virtual World Intervention

The University of Texas Health Science Center, Houston8 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
175
试验地点
8
主要终点
Self-esteem as assessed by the Rosenberg Self-Esteem Scale

研究概览

简要总结

The purpose of this project is to test the efficacy of an internet-based psychological health enhancement program for women with spinal cord injury. The intervention will occur in Second Life (SL), which is an online virtual word simulator with a group of women with spinal cord injury.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • have a traumatic spinal cord injury
  • be at least one year post injury
  • be able to speak and read English (to participate in the group intervention and complete study questionnaires in English).
  • have access to a phone, an email account, and a computer and high-speed Internet connection that meets minimum SL computing requirements.

排除标准

  • have a cognitive impairment that significantly limits their ability to give informed consent, participate in the intervention, or complete study assessments as determined by an inability to correctly answer questions on a comprehension of consent questionnaire
  • have a significant visual or hearing impairment that would prohibit their ability to participate in the virtual intervention
  • report active suicidality
  • live in institutions. Individuals living in community-based group and adult foster homes will be invited to participate.

结局指标

主要结局

Self-esteem as assessed by the Rosenberg Self-Esteem Scale

时间窗: 6 months

The effect of the Zest intervention on self-esteem as assessed by the Rosenberg Self-Esteem Scale. This is a 10-item scale with scores ranging from 10-40 with higher scores indicating higher self-esteem.

Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)

时间窗: 6 months

The effect of the Zest intervention on depression as assessed by the Patient Health Questionnaire-9 (PHQ-9). This is a 9-item scale with scores ranging from 0-27 with higher scores indicating more severe depression.

Life satisfaction as assessed by the Satisfaction with Life Scale

时间窗: 6 months

The effect of the Zest intervention on life satisfaction as assessed by the Satisfaction with Life Scale. This is a 5-item scale with scores ranging from 5-35 with higher scores indicating greater satisfaction with life.

次要结局

  • Self-efficacy as assessed by the Generalized Self-Efficacy Scale(6 months)
  • Social connectedness as assessed by the Medical Outcomes Study Social Support Scale, Emotional/Informational Support subscale.(6 months)
  • Perceived stress as assessed the by Perceived Stress Scale(6 months)

研究者

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

Susan Robinson-Whelen

Assistant Professor

The University of Texas Health Science Center, Houston

研究点 (8)

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