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临床试验/NCT03923946
NCT03923946已完成不适用

STRICTLy CFT: A Feasibility Randomised Control Trial of a Compassion Focussed Therapy Intervention to Aid Recovery Post-stroke

University of Lincoln2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019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
24
试验地点
2
主要终点
Feasibility of an RCT design

研究概览

简要总结

Individuals who have had a stroke are at greater risk of developing distress (e.g. depression and anxiety). These individuals are also likely to be highly critical of themselves as they are no longer able to do the things they used to be able to do.

Compassion Focused Therapy is a form of psychotherapy aimed at reducing an individual's self-criticism and increasing their self-compassion. CFT has been found to be effective at reducing distress in the general population and there is emerging evidence in the brain injury population. However, to date, there has not been a rigorous study to establish the effectiveness of CFT. Therefore, this feasibility randomised control trial aims to:

Establish the feasibility of recruitment, randomisation, and retention of participants; determine the acceptability and feasibility of a CFT intervention within a stroke population; determine the suitability of pre and post measures for assessing the impact of the intervention; Analyse the cost-effectiveness of the study; Establish effect sizes to enable an accurate estimation of the number of participants needed in a full scale RCT to find a treatment effect.

Individuals will be randomised into either a CFT intervention group, an active control arm (akin to a befriending type service) or a treatment as usual arm. Participants will receive up to three one hour sessions of CFT (intervention group) or befriending (active control group) or will not receive any additional support (treatment as usual group).

A total of 36 participants will be recruited, 12 in each arm of the study. Participants will be recruited from the Early Supported Stroke Discharge Teams within Derbyshire.

Participants will complete well-being, distress and self-criticism measures, pre, post and at 4 months follow-up. A semi-structured interview will also be conducted with a selection of participants from each arm.

详细描述

Stroke Stroke is a type of acquired brain injury (ABI) and is a heterogeneous term used to describe both ruptures to large blood vessels in the brain causing flooding with blood, and occlusions of tiny vessels in a part of the brain that is vital for functioning.

In the UK stroke is the second leading cause of death and disability, second only to coronary heart disease. Approximately 110, 000 strokes occur each year in England with prevalence rates estimated to be 7.20/1000.

Strokes can lead to changes in functioning in a variety of areas of life. As a result, individuals can often experience a range of emotional difficulties. For example, there is a high prevalence of mental health difficulties in stroke survivors; the most commonly reported are depression and anxiety disorders. Prevalence rates of distress vary between studies; however, it is estimated that the prevalence of post-stroke depression is approximately 31%, and post-stroke anxiety is estimated to be 18%. High levels of depression and anxiety can augment the functional impairments experienced as a result of a stroke. Depression in particularly is associated with reduced functioning outcomes and increased mortality rates.

In addition, studies have found high levels of self-criticism post-stroke as individuals realise they are no longer able to do things which they used to be able to. Studies have found higher rates of depression in individuals who continue to pursue what have now become unachievable life goals. It is postulated that this could be one of the reasons for the high prevalence rate of depression post-stroke, particularly if individuals do not re-evaluate their life goals to realign with any changes in cognitive capacity and functional deficits as a result of the stroke.

National Institute for Health and Care Excellence Guidance has suggested that individuals who have had a stroke should have access to psychological therapy to help with difficulties adjusting to life post-stroke. One such therapy is Compassion Focussed Therapy (CFT) which aims to reduce self-criticism by increasing self-compassion. CFT may be particularly effective in this population due to the specific challenges faced. For example, they have to adjust to the loss of previous functioning (both cognitively and otherwise) alongside managing the threat that a stroke may reoccur and the gradual and often frustrating nature of recovery which may be conditional on clinical input. The picture can then be complicated further by an individual's self-criticism tendencies which, as described above, can compound any challenges the individual is already facing. Therefore, CFT, which aims to reduce self-criticism and foster adjustment through self-compassion, would appear to be a well-suited intervention in this population.

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

盲法说明

Due to the active nature of the interventions it is not possible to mask participants.

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

  • Eligible for the early supported discharge pathway this includes:
  • Confirmed diagnosis of a new stroke.
  • Over 18 Years old.
  • Able to consent to being in the study.
  • The patient and their family/carer agree to rehabilitation process continuing at home.
  • The home environment is conducive to the community-based rehabilitation.
  • Achievable rehabilitation goals can be identified.
  • Document acknowledgement that the patient is sufficiently well enough from a medical perspective to be managed in the community.
  • The patient's language and/or cognitive skills are at a level for them to manage on their own for periods as is necessary.
  • In addition to ESSD criteria participants must;
  • Have a good grasp of the English language
  • Have been discharged from the ESSD pathway

排除标准

  • Participants will be excluded if they:
  • Have any communication difficulties that would prevent them from engaging in the intervention (including hearing impairments, visual impairments, inability to understand English). These will be assessed at researcher's discretion during baseline assessments.
  • Had a diagnosis of dementia prior to the stroke.
  • Are deemed to lack capacity to give informed consent. This will be judged via a qualified clinician.
  • Have had previous experience of CFT
  • Were receiving medical or psychological treatment for a mental illness at the time of their stroke.

结局指标

主要结局

Feasibility of an RCT design

时间窗: 4 months (per participant)

Answers from post-intervention interviews

次要结局

  • Process(6 weeks)
  • distress(6 weeks)
  • well-being(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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