Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04655937
Status:
COMPLETED
Last Update Posted:
2024-05-10
First Post:
2020-11-17
Brief Title:
Wellbeing After Stroke WAterS Supporting Adjustment and Wellbeing After Stroke
Sponsor:
University of Manchester
Organization:
University of Manchester
Study Overview
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WAterS
Brief 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 mildmoderate 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 dont 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
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 mildmoderate 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 dont 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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None