Wellbeing After Stroke (WAterS): Supporting Adjustment and Wellbeing After Stroke — WAterS  

Stroke Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

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:

1. 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.

2. 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

Clinical Trial Description

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).

Methods: There are three work packages described that, whilst distinct, do overlap in terms of participants and timelines. All methods and study materials have been informed through collaboration with stroke survivors and carers through the WAterS Patient and Carer Public Involvement (PCPI) Research User Group (RUG):

• Work package 1 (staff training): remotely training paraprofessionals to deliver the remote ACT intervention. Through qualitative research and competency exercises, explore whether this equips staff with confidence and skills to deliver the study components.

• Work package 2 (pilot study): explore the acceptability of outcomes data collection separate to the acceptability of delivering remote group intervention and other study components. Eligible stroke survivors are recruited with baseline clinical and demographic information collected. They are invited to contribute self-report outcomes data about their psychological wellbeing, every three months for up to 12 months. Participant groups includes a no-treatment group, and a group that is invited to participate in the ACT intervention (9 short weekly sessions delivered by zoom). Stroke survivors attending intervention groups will be asked to complete additional self-report outcomes data in weeks 1 and weeks 9 of the groups.

• Work package 3 (process evaluation; runs in parallel with pilot trial): observation and filming of intervention group will facilitate monitoring of fidelity, as well as provide opportunities for paraprofessional facilitators to reflect on delivery and competency during ongoing clinical supervision. In addition, the acceptability of course content to stroke survivor attendees will be explored through postal or online feedback questionnaires and qualitative interviews.

Participants. Up to 10 professionals (Stroke Association Coordinators) with some experience of supporting stroke survivors and facilitating groups will be recruited for training in Work Package 1 and subsequent facilitation of groups. Professionals will be recruited from sites across England. For Work packages 2 and 3: up to 30 stroke survivors who are at least four months post-stroke and experiencing difficulties with adjustment and psychological distress will be recruited across the UK using a variety of methods to explore optimal recruitment routes over a 6 month period.

The study is underpinned by United Kingdom Medical Research Council (MRC) updated guidance on developing and evaluating complex interventions. MRC advises that feasibility work can uncover and explore problems of acceptability, compliance, delivery, recruitment and retention; and they recommend that process evaluations are embedded to increase understanding of the intervention and optimise its design and evaluation. At the feasibility stage, process evaluation is an active and iterative process, and changes can and should be made and acted upon while the trial is on-going. As such, the methodological principles are outlined in this record, but it is likely that some specifics may be adjusted as data are collected and learning is implemented.

All data (including recordings) will be handled in line with University of Manchester approved protocols and Study-specific Data Management Plan to ensure the safety and security of data. ;

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Communication Disorders
• Psychological Adjustment
• Psychological Distress
• Stroke

• NCT number: NCT04655937
• Study type: Interventional
• Source: University of Manchester
• Status: Completed
• Phase: Phase 1
• Start date: January 5, 2021
• Completion date: May 1, 2023