Wellbeing After Stroke (WAterS)

Summary

Participation Requirements

Description

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 Co...

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 paraprofessionals (Stroke Association coordinators) to deliver the course. Aims: The study aims to explore feasibility and acceptability of paraprofessionals delivering the adapted ACT intervention to stroke survivors in community settings in the context of a modified pilot randomised consent trial, with a non-randomised no-treatment group and a randomised active comparator arm (attention control) that is also delivered by paraprofessionals. 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 Research User Group (RUG): Work package 1 (staff training): remotely training paraprofessionals to deliver either the remote ACT intervention or attention control. Through qualitative research and competency exercises, explore whether this equips staff with confidence and skills to deliver the study components. Work package 2 (pilot trial): a modified randomised consent design allows for exploration of the acceptability of outcomes data collection separate to the acceptability of delivering remote group interventions 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. Participants groups will include a no-treatment group, and a group that is randomised and subsequently invited to participate in either the ACT intervention (8 short weekly sessions delivered by zoom) or an attention control group (involving social attention; time-matched sessions). Stroke survivors randomised and attending groups (intervention or attention control) will be asked to complete additional self-report outcomes data in weeks 1 and weeks 8 of the groups. Work package 3 (process evaluation; runs in parallel with pilot trial): observation and filming of groups (intervention and attention control) 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 paraprofessionals (Stroke Association Coordinators) with some experience of supporting stroke survivors and facilitating existing social support groups will be recruited for training in Work Package 1 and subsequent facilitation of groups. Paraprofessionals will be recruited from sites across the North of England. For Work packages 2 and 3: up to 60 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 12 month period. The study is underpinned by United Kingdom Medical Research Council (MRC) 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.

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