跳至主要内容
临床试验/NCT05346913
NCT05346913Unknown不适用

Internet-Delivered Cognitive Behaviour Therapy Program for Caregivers of Persons With Spinal Cord Injury: A Pilot Study

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's0 个研究点目标入组 20 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
主要终点
Change in Caregiver Burden

研究概览

简要总结

Spinal cord injuries have a devastating effect on individuals incurring the life changing event; however, the injury can also affect those who are integrally involved in their care. Assisting individuals after an SCI frequently falls on unpaid, family caregivers. Studies have reported that caregivers experienced significantly greater negative outcomes than positives. The most common negative outcome factors were high levels of burden, poor adjustment to role, decreased QOL, emotional distress, and strain on relationships. Burden of care was also associated with lower levels of functioning of the care recipient, demonstrating the integral relationship between those who provide care and those who receive it. Considering their importance in maintaining their care recipient's wellbeing post-injury, caregivers require ongoing support as a central part of the wider healthcare system. Numerous caregivers are unprepared to handle the responsibilities of their role and lack specialized training to efficiently cope with the burden. Guided internet-delivered CBT (ICBT) offers an accessible and flexible approach for psychosocial service delivery in the community. Evidence for the effectiveness of ICBT has been reported in various populations. The results from our study provide evidence for the potential of guided ICBT to improve psychosocial outcomes among those with SCI. Enhancing the overall wellbeing of the caregiver has previously been shown to improve outcomes of those with SCI. However, evidence for the acceptability and effectiveness of an ICBT approach among caregivers is lacking; as a first step, we plan to conduct a feasibility study of ICBT for SCI caregivers.

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

  • adults ≥ 18 years
  • have provided care to a person with SCI in the community for a period of over six months post injury
  • report elevated symptoms of anxiety and/or depression
  • access to a computer and the internet
  • cognitive capacity to read and understand the content of the intervention.

排除标准

  • high risk of suicide
  • primary problems with psychosis, alcohol or drug problems, mania
  • currently receiving active psychological treatment for anxiety or depression
  • concerns about online therapy.

研究组 & 干预措施

Caregivers of Persons with Spinal Cord Injury (mTBI)

Experimental

干预措施: Internet-delivered Cognitive Behavioural Therapy(ICBT) (Behavioral)

结局指标

主要结局

Change in Caregiver Burden

时间窗: Time Frame: Baseline to 3 months

Craig Caregiver Assessment of Reward and Effort. Higher scores indicate greater caregiver. Scores range from 0 to 96.

Change in Depression

时间窗: Time Frame: Baseline to 3 months

Patient Health Questionnaire - 9 Item (PHQ-9). Higher total scores indicate greater severity of depression. Scores range from 0 to 27.

次要结局

  • Change in Anxiety(Time Frame: Baseline to 3 months)
  • Change in quality of life(Time Frame: Baseline to 3 months)

研究者

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

Swati Mehta

Scientist, Principle Investigator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

相似试验