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临床试验/NCT06072287
NCT06072287招募中不适用

Testing the Reliability and Validity of a New Measure for Illness-related Distress.

King's College London1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2023年6月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
600
试验地点
1
主要终点
Illness-related distress

研究概览

简要总结

Psychological distress (anxiety and depression) is common in and experienced differently by people living with long-term health conditions (LTCs). Being able to measure whether psychological distress is related to living with a LTC would allow researchers and clinicians to provide interventions specifically tailored to the challenges of living with a LTC and therefore provide the most appropriate support for these patients. Such a measure would also be useful in research to identify the presence of illness-related distress in different patient groups. This project will therefore create a new measure of illness-related distress that has applications for both research and clinical practice. This will involve the psychometric validation of the new illness-related distress measure to test how valid and reliable the measure is.

The aim of the project is to provide initial validation of the Illness Related Distress Scale in a community sample, recruited through online platforms. The objective of the study is to gather initial validity and reliability data for the scale.

详细描述

Background: see brief summary

Project information:

This study will be conducted online with participants from the UK. A series of standardised questionnaires will be used alongside the new questionnaire.

Participants will be those who self-select to complete our survey by responding to advertisements. The invitation will include a link to the Qualtrics survey which includes the Participant Information Sheet, Eligibility Screening, Consent Form and Baseline Questionnaire.

After completing eligibility screening and consent, participants will complete the baseline questionnaire which will include brief demographics (highest education level, long-term condition diagnoses, ethnicity age and gender), the new measure we are testing (the Illness Related Distress Scale), as well as the Patient Health Questionnaire (PHQ-8), Generalised Anxiety Disorder Scale (GAD-7), the Work and Social Adjustment Scale (WSAS). The baseline questionnaire will only include the Inflammatory Bowel Disease Distress Scale (IBD-DS) and Diabetes Distress Scale (DDS) if participants indicate that they have a diagnosis of the relevant condition.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • •Over the age of 18
  • •Self-reported diagnosis of a Long-Term Condition
  • •UK resident
  • •Possession of an email address to enable all study procedures
  • •Sufficient command of written and spoken English to understand study procedures

排除标准

  • •Under the age of 18
  • •Not living in the UK
  • •No self-reported diagnosis of an LTC
  • •Inability to complete questionnaires in English

研究组 & 干预措施

Participants

Participants will answer two short questionnaires, 1 week apart.

干预措施: Living with LTC Questionnaire (Diagnostic Test)

结局指标

主要结局

Illness-related distress

时间窗: Week 0 and Week 1

31 item questionnaire developed by the research team designed to assess illness-related distresss.

次要结局

  • Cognitive and Behavioural Responses to Symptoms(Week 0)
  • Depression(Week 0)
  • Anxiety(Week 0)
  • Functional impairment(Week 0)
  • Diabetes Related Distress Scale(Week 0)
  • IBD Distress Scale(Week 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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