Wellbeing After Stroke (WAterS) Pilot Study Exploring Upskilling a Workforce to Deliver Acceptance and Commitment Therapy (ACT) for Improving Psychological Adjustment and Wellbeing for Groups of Community-based Stroke Survivors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Study-specific participant qualitative interviews
研究概览
简要总结
Stroke survivors face a range of mental health challenges adjusting post-stroke. There is a lack of treatment options and clinical psychologist workforce to deliver support. Acceptance and Commitment Therapy (ACT) has been used successfully in clinical services to improve wellbeing.
The investigators worked with stroke survivors, health care professionals and researchers to co-develop group ACT therapy, specifically for stroke survivors, to be delivered using video calling (Zoom). Staff training and supervision programmes were also developed to equip Stroke Association workforce (paraprofessionals) to deliver ACT.
The current study will recruit and train up to 10 professionals with some experience of supporting stroke survivors but no experience of ACT.
We then aim to recruit up to 30 stroke survivors in the community who are at least 4 months post-stroke and experiencing distress adjusting to their stroke. The investigators aimed to make everything accessible for people with mild/moderate difficulties with thinking and communicating. Recruitment took place across England, over a 6 month period.
The study will test how feasible and acceptable it is to deliver the co-developed, remote ACT intervention to stroke survivors, as well as the feasibility of collecting outcomes data:
- Participants will be invited to consent to complete online measures of well-being every 3 months for up to 12 months (taking around 20 minutes), with the option to participate in group intervention. Those who don't opt for groups will not be treated but will be followed up about their wellbeing, if they agree.
- Those who opt to attend groups will be randomly assigned into intervention groups A, B, or C and receive the ACT intervention, involving 9 weekly sessions and homework.
Data will be collected on how successfully the groups are delivered and how acceptable they are / how to improve them, through online surveys, feedback questionnaires and interviews.
UPDATE May 2023: The investigators had initially intended to run an active comparator arm of social support and randomly allocated people to arms *and* groups. However, the design changed after the COVID-19 pandemic, meaning that the planning phases took longer than expected in order to pivot all study components to be deliverable online.
*Please see references section for our findings and publications
详细描述
UPDATE May 2023: The design changed after the COVID-19 pandemic meant that the planning phases took longer than expected in order to pivot all study components to be deliverable online. Changes are outlined below but to summarise: The study became an observational proof of principle feasibility study with no randomised attention control comparator arm, as was originally planned.
*Please see references section for our findings and publications
Background: Stroke survivors face a range of mental health challenges during the adjustment process post-stroke. It is not always easy for stroke survivors to access treatment to help them face these challenges, due to the lack of interventions and access to clinical psychologists. Acceptance and Commitment Therapy (ACT) has good theoretical underpinning to support adjustment post stroke. The potential benefits of ACT may be further increased by group delivery.
The investigators have worked with stroke survivors, expert clinicians and researchers to develop an ACT intervention to be delivered remotely to groups, to support their adjustment and wellbeing post-stroke. The investigators have also developed a remote staff training and clinical supervision programme to equip professionals with no prior experience of ACT (Stroke Association coordinators) to deliver the intervention (typically an ACT intervention would be delivered by Clinical Psychologists).
Aims: The study aims to explore feasibility and acceptability of trained professionals delivering the adapted ACT intervention to stroke survivors in community settings in the context of a pilot study, with a potential no-treatment group (follow up only).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
- Participants attend the group if they agree to invitation and accept.
- Staff / Care providers are trained and cannot be masked
- Key outcomes are provided through self-report data from participants and therefore cannot be masked.
Other outcomes - related to acceptability and feasibility - are collected by the research team. The research team is small and funding is minimal so we cannot mask the research team.
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
- 未提供
排除标准
- •Adults in the UK (at least 18 years old)
- •At least 4 months post-stroke (no upper limit);
- •Who identify as having unmet needs in terms of psychological adjustment to stroke and psychological distress. Since exploring eligibility criteria is an aim of this feasibility study, self-report of these symptoms will be sufficient for inclusion. Participants who identify as severely anxious or depressed (or at risk of harm) are likely to be excluded from this research, with information on referral to more appropriate expert psychological support will be provided.
- •Sufficient English language to engage in groups / complete measures
- •Ability to engage in remote group interventions. The groups will be designed to include those who have traditionally been excluded from work like this e.g. those with cognitive and/or communicative difficulties. However, it is important to highlight that this is not an intervention designed for severe issues in these areas. We will aim to include all participants who self-report a willingness and ability to engage in the research, using the required technologies.
- •Ultimately, we aim to be as inclusive as possible for this study as there are many novel components of the research that we are exploring in terms of feasibility and acceptability. The data collected during the feasibility study describing sample characteristics, acceptability and outcomes may inform formal cut offs to be used in an eventual phase III RCT.
结局指标
主要结局
Study-specific participant qualitative interviews
时间窗: Following 9 week group support delivery,
This is a feasibility and acceptability study so no defined primary outcome (although we are collecting many candidate measures to explore standard deviations and inform primary outcome for any eventual phase III trial). Participant interviews will help us understand more about acceptability and feasibility, alongside observational data e.g. recruitment rates; retention rates; satisfaction and acceptability; fidelity measures etc.
Study-specific participant feedback questionnaire
时间窗: Following 9 week group support delivery
As above, with all participants being asked to complete feedback questionnaires after groups, even if they do not wish to participate in interviews
Acceptance and Commitment Therapy Fidelity Measure (ACT-FM)
时间窗: Following 9 week ACT group support delivery
To help us understand if we can /have achieved fidelity to intervention; a key piece of knowledge that will inform feasibility of a phase III trial. All ACT group sessions will be video recorded with a randomly selected sample reviewed against the ACT-FM. ACT groups ran in August 2021(max N=2) and October 2021 (max N=2). There are 9 weekly recorded sessions per group, giving a maximum of 36 recorded sessions.
次要结局
- Psychological distress at baseline and every 3 months as measured by Clinical Outcomes in Routine Evaluation 10 (CORE-10)(baseline + every 3 months up to 12 months)
- Mood at baseline and every 3 months as measured by General Health Questionnaire - 12 items (GHQ12)(baseline + every 3 months up to 12 months)
- Personal wellbeing at baseline and every 3 months as measured by the Office of National Statistics (ONS) four subjective well-being questions (ONS4)(baseline + every 3 months up to 12 months)
- Psychological flexibility at baseline and every 3 months as measured by the Acceptance and. Action Questionnaire - Acquired Brain Injury (AAQ-ABI)(baseline + every 3 months up to 12 months)
- Valued living measure at baseline and every 3 months as measured by the Valuing Questionnaire (VQ)(baseline + every 3 months up to 12 months)
研究者
Dr Emma Patchwood
Research Fellow
University of Manchester