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临床试验/NCT04670406
NCT04670406已完成不适用

A Guided Online Acceptance and Commitment Therapy (ACT) Intervention Combined With Psychoeducation for People With Spinal Cord Injury: A Preliminary Study

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年5月7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
10
试验地点
2
主要终点
World Health Organization Quality of Life Instruments (WHOQOL-BREF) - psychological health component

研究概览

简要总结

The purpose of this preliminary study is to examine the effects of a guided online acceptance and commitment therapy (ACT) intervention combined with psychoeducation on people with spinal cord injury (SCI) who experience psychological distress.

详细描述

This project will employ a one-group pretest-posttest design to investigate the effects of a guided online acceptance and commitment therapy (ACT) intervention combined with psychoeducation on quality of life and mental health of people with spinal cord injury (SCI) who experience psychological distress. After the pretest evaluation, eligible participants will receive 8 weekly sessions, including 6 ACT sessions and 2 psychoeducation sessions, delivered by trained coaches through Zoom videoconferencing. Each session lasts for one hour. Primary outcome measures will be psychological distress measured by the Depression, Anxiety and Stress Scale (DASS)- 21 and Spinal Cord Injury - Quality of Life (SCI-QOL). A one-time interview at the completion of the 8 sessions will be conducted to explore participants' experiences in the sessions.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • community-dwelling adults (age 18 or over) living in the community who had a spinal cord injury
  • suffering at least mild symptoms of psychological distress measured by the DASS-21
  • having a computer/smartphone with internet access capable of doing web browsing and video-conferencing
  • being able to provide informed consent by understanding the nature of study participation.

排除标准

  • having cognitive, physical, or sensory deficits, or language barriers (non- English communicator) that impede study participation
  • receiving a psychological therapy currently
  • having psychiatric hospitalizations or diagnoses of mental illness in the previous 2 years
  • taking antipsychotic or anticonvulsant medication at the time of recruitment
  • having the possibility of study dropouts due to other medical conditions

结局指标

主要结局

World Health Organization Quality of Life Instruments (WHOQOL-BREF) - psychological health component

时间窗: Change from baseline to 8 weeks

WHOQOL-BREF - psychological health component has 6 items measuring: bodily image and appearance; negative feelings; positive feelings; self-esteem; spirituality / personal beliefs; and thinking, learning, memory and concentration. Higher scores denote higher quality of life in terms of psychological health.

Depression, Anxiety and Stress Scale (DASS) - 21

时间窗: Change from baseline to 8 weeks

The Depression, Anxiety and Stress Scale (DASS)- 21 is a 21-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and stress. Higher scores represent greater symptomatology.

次要结局

  • Action and Acceptance Questionnaire (AAQ)-II(Change from baseline to 8 weeks)
  • Spinal Cord Injury - Quality of Life (SCI-QOL) Resilience Short form(Change from baseline to 8 weeks)
  • Self-Compassion Scale- Short Form (SCS-SF)(Change from baseline to 8 weeks)
  • Engagement in Meaningful Activities Survey (EMAS)(Change from baseline to 8 weeks)
  • Spinal Cord Injury - Quality of Life (SCI-QOL) Grief and Loss Short form(Change from baseline to 8 weeks)
  • Cognitive Fusion Questionnaire (CFQ)-7(Change from baseline to 8 weeks)
  • Mindful Attention Awareness Scale (MAAS)(Change from baseline to 8 weeks)

研究者

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

Areum Han

Assistant professor

University of Alabama at Birmingham

研究点 (2)

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