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临床试验/NCT06992869
NCT06992869已完成不适用

Matching Mental Health Support to the Needs of People Affected by Parkinson's: Patient and Cost Benefits

University College, London1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2024年7月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
138
试验地点
1
主要终点
PHQ-9

研究概览

简要总结

In addition to increasingly severe physical symptoms, Parkinson's can cause distressing mental health issues. These include anxiety, depression, and memory and thinking problems, caused by a combination of biological and psychological factors. They can be more disabling than physical symptoms, reduce quality of life and increase risk of mortality. They are also upsetting for family members and unpaid carers, and may necessitate transfer to institutional care. They also increase NHS costs because of expensive hospital admissions. Despite this, there are few specialist mental health professionals or psychological interventions available to help people with Parkinson's.

This study will address this by developing an effective programme of evidence-based psychological interventions for mental health issues in Parkinson's that can be easily delivered by non-experts. Parkinson's mental health specialists at UCL Queen Square Institute of Neurology will work with people affected by Parkinson's and non-psychology health professionals to design specialist interventions for three key mental health needs in Parkinson's, targeted at distinct stages:

  1. Adjusting to diagnosis; empowering people to feel more in control.
  2. Anxiety and/or depression; using cognitive-behavioural therapy techniques to improve mood, with particular focus on Parkinson's-specific concerns.
  3. Advanced Parkinson's; helping people with Parkinson's and those around them to improve management of memory and thinking problems.

The research team will design companion booklets for participants, summarizing each session. The treatment will be piloted for one year. If the interventions prove beneficial to participants and are cost-effective, the resources will be made immediately available to healthcare staff across the UK to improve access to specialist psychological services.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Supportive Care
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
否

入选标准

  • •Diagnosis of Parkinson's AND
  • •within three years of diagnosis OR
  • •anxiety/depression, as judged by scores above clinical cut-offs on standardized measures OR
  • •developing Parkinson's-related cognitive impairment/hallucinations/delusions, but retaining capacity to consent, as judged by their medical consultant.
  • •Aged 18 years and above
  • •Sufficiently fluent in English
  • •Able to give informed consent
  • •Able to attend Queen Square for the intervention
  • •Able to complete the self-report questionnaires
  • •Exclusion Criterion:
  • •Already participating in psychological therapy or research aimed at improving psychological wellbeing.

排除标准

  • 未提供

研究组 & 干预措施

Group-based psychological therapy

Experimental

干预措施: Group-based psychological therapy (Behavioral)

结局指标

主要结局

PHQ-9

时间窗: Change in PHQ-9 scores after 8 weeks of intervention

Standardized measure of depression

GAD-7

时间窗: Change in GAD-7 scores after 8 weeks of intervention

Standardized measure of anxiety

PDQ-39

时间窗: Change in PDQ-39 scores after 8 weeks of intervention

Standardized measure of quality of life in Parkinson's disease

Brief-COPE

时间窗: Change in Brief-COPE scores after 8 weeks of intervention

Standardized measure of coping

次要结局

  • Acceptability(Following the 8 weeks of intervention)
  • Ease of delivery by non-experts(Following 8-weeks of intervention)
  • Ease of delivery by non-expert(Following 8-weeks of intervention)
  • Acceptability(Following the 8 week intervention)
  • Healthcare resource use(Change in CSRI healthcare use after 8 weeks of intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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