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临床试验/NCT03295032
NCT03295032已完成不适用

A Mixed-methods Evaluation of an Adapted Acceptance and Commitment Therapy (ACT) Group for Stroke Survivors and Their Carers: ACTivate Your Life After Stroke

Cardiff University4 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2016年3月1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
53
试验地点
4
主要终点
Measuring a change in PHQ9 scores

研究概览

简要总结

Stroke is one of the main causes of acquired adult disability in the UK. Many psychological problems can also occur post-stroke; this has a marked impact on health service usage. As such, there is an outstanding need to increase and improve psychological resources within stroke services.

The investigators proposed to adapt and evaluate the effectiveness of an acceptance and commitment therapy (ACT) group intervention for adult stroke survivors and their carers. The group will endeavour to promote positive adjustment and reduce levels of depression and anxiety.

This study will have two parts.

详细描述

Stroke is one of the main causes of acquired adult disability in the UK. In England and Wales, over 900,000 people are living with the chronic illness, which can cause sufferers to be highly dependent on others for their care. Many psychological problems can also occur including: depression, anxiety and fatigue. This has a marked impact on health service usage. There is an outstanding need to increase and improve psychological resources within these services.

Acceptance and Commitment Therapy (ACT) has a well-established evidence base for reducing psychological distress in individuals with mental illness and physical health conditions including: diabetes, chronic pain, epilepsy & cancer. It is hoped that the investigators can apply this same model to support stroke survivors and their carers.

The investigators propose to evaluate the effectiveness of an adapted ACT group intervention for adult stroke survivors and their carers. The benefit of ACT is that it is transdiagnostic therefore applicable to the very wide range of psychological problems found in carers and survivors after stroke. This ACT group is a stroke adapted version of the already existing 'ACTivate your life' course, which is being run by the NHS for people with mental health difficulties across South Wales. The course endeavours to promote positive adjustment and reduce levels of depression and anxiety, using the core tenets of ACT.

This study will have two parts. Part 1: a quantitative phase evaluating the effectiveness of the ACT group using outcome data in comparison to a waiting list control across three time points. Part 2: A qualitative phase exploring stroke survivors experiences of the ACT group and their perceptions of any change from group attendance.

PART 1:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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
否

入选标准

  • •All participants must be >18 years
  • •Clinical diagnosis of stroke (or carers of someone who has experienced a stroke)
  • •Must be able to understand English and communicate responses.
  • •The target volunteer has been referred to this stroke-adapted ACT course by a clinician.

排除标准

  • •Patients with any other acquired brain injury e.g. traumatic brain injury, encephalitis, tumours etc.
  • •Patients diagnosed with a degenerative condition e.g. dementias.
  • •Significant cognitive/language impairment that would prevent them from engaging with the group.
  • •Those experiencing severe psychotic symptoms
  • •Those who are receiving other therapies, as part of a multicomponent intervention which would prevent any changes specific to group psychotherapy to be estimated (with the exception of drugs for anxiety and depression).

研究组 & 干预措施

group-based ACT

Experimental

Stroke survivors were randomised into group-based ACT intervention consisting of 2hr sessions for four consecutive weeks.

干预措施: Acceptance and Commitment Therapy (ACT) (Behavioral)

Waiting list control

No Intervention

Waiting list control - received treatment as usual.

结局指标

主要结局

Measuring a change in PHQ9 scores

时间窗: baseline, 4 weeks and two month follow-up

measure of depression

次要结局

  • Measuring a change in Warwick and Edinburgh Mental Wellbeing Scale (WEMWBS) scores(baseline, 4 weeks and two month follow-up)
  • Measuring a change in EQ-5D-5L scores(baseline, 4 weeks and two month follow-up)
  • Measuring a change in GAD7 scores(baseline, 4 weeks and two month follow-up)
  • Measuring a change in Adult Hope Scale (AHS) scores(baseline, 4 weeks and two month follow-up)

研究者

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

Rebecca Large

Principal Investigator

Cardiff University

研究点 (4)

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