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临床试验/NCT06618404
NCT06618404已完成不适用

Establishing the Mental Health Needs of People With Spinal Cord Injury

University of Reading1 个研究点 分布在 1 个国家目标入组 318 人开始时间: 2021年5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
318
试验地点
1
主要终点
Anxiety

研究概览

简要总结

Mental health decline after Spinal Cord Injury (SCI) is commonly reported but minimally investigated in the United Kingdom. The current study aims to explore the prevalence and impact of mental health challenges after SCI to establish population norms in the UK. Additionally the current study will aim to identify barriers to and facilitators of mental health support seeking in people with SCI.

详细描述

A four-phase mixed methods research study will be undertaken. Phase One will be a cross-sectional online survey designed to determine the prevalence of mental health conditions in adults with SCI in the UK assessing resilience, anxiety, depression, pain, life satisfaction, PTSD and coping self-efficacy.

Phase Two will consist of in-depth semi-structured online interviews conducted with approximately twenty people with Spinal Cord Injury who, in the first study, indicated either that the participants had accessed, or had wanted to access mental health services. The two-part interview schedule will be undertaken, covering: 1) core themes surrounding the causes of, changes in, and management of mental health after SCI; and 2) questions relating to participant hopes for and experiences of satisfaction with, access to and efficacy of mental health services, in the context of the mental health service providers which participants currently use or have attempted to access.

Phase Three will consist of in-depth semi-structured online interviews held with approximately twenty 'significant others' (partner/family/friend) of people with Spinal Cord Injury whose family member/partner/friend experience mental health problems. The interview schedule will cover two core themes surrounding: 1) perceptions of the causes and impact of mental health difficulties after SCI on 'significant others'; 2) their experiences of current mental health services provided for participants' partner/family/friend and perceived recommendations and hopes for better management of mental health in participants' family member/partner.

Phase Four will recruit twenty-five people with high resilience (>30 on the CD-RISC-10) to participate in an in-depth semi-structured online interview. This will review participants' thoughts and perceptions about resilience and how it is possible to maintain a high level of resilience whilst living with spinal cord injury.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

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

  • Phases 1 and 2 (survey and SCI interviews)
  • Adults with spinal cord injury
  • Adults with cauda equina syndrome

排除标准

  • Difficulty with written or verbal English Language comprehension
  • Inclusion Criteria: Phase 3
  • Partner, Spouse, Family member or carer of a person with Spinal Cord Injury
  • Exclusion criteria:
  • Difficulty with verbal English Language comprehension
  • Inclusion Criteria: Phase 4
  • Adults with Spinal Cord Injury who screen as having resilience higher than 30 on the Connor-Davidson Resilience Scale (CDRS-10).
  • Exclusion Criteria: Phase 4
  • Adults with Spinal Cord Injury with resilience lower than 30
  • Adults with Spinal Cord Injury who choose not to complete the CDRS-10.

结局指标

主要结局

Anxiety

时间窗: Baseline

Generalised Anxiety Disorder Scale (GAD-7); minimum score = 0; maximum score = 21; Scores higher than 15 represent severe clinical levels of anxiety.

Depression

时间窗: Baseline

Patient Health Questionnaire-9 (PHQ-9); minimum score = 0; maximum = 27; scores over 20 represent severe clinical depression.

Post-traumatic Stress Disorder

时间窗: Baseline

Impact of Event Scale-Revised (IES-R); 22 item measure of PTSD; minimum score = 0; maximum score = 88; scores over 33 indicate the clinical cut-off for probable PTSD.

次要结局

  • Pain Interference(Baseline)
  • Coping Self-efficacy(Baseline)
  • Resilience(Baseline)
  • Life Satisfaction(Baseline)

研究者

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

Katherine Finlay

Dr Katherine Finlay, Lecturer in Psychology

University of Reading

研究点 (1)

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