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

NCT04655937 | Completed Phase 1

• 1 other identifier: IRAS ID: 287785
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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. 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. 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.

Conditions

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

Keywords

Acceptance and Commitment Therapy; Psychotherapy; Trained professionals; Feasibility; Acceptability; Remote intervention

Outcome Measures

Primary Outcomes (3)

• Study-specific participant qualitative interviews

  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.

  Following 9 week group support delivery,

• Study-specific participant feedback questionnaire

  As above, with all participants being asked to complete feedback questionnaires after groups, even if they do not wish to participate in interviews

  Following 9 week group support delivery

• Acceptance and Commitment Therapy Fidelity Measure (ACT-FM)

  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.

  Following 9 week ACT group support delivery

Secondary Outcomes (5)

• 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

Other Outcomes (3)

• modified Barthel Index (self-report)

  baseline

• Oxford Cognitive Screen (OCS) - Remote

  baseline

• Frenchay Aphasia Screening Test (FAST) - remote & Therapy Outcome Measure for Communication Activities

  baseline

Study Arms (2)

non-randomised no treatment arm

NO INTERVENTION

Participants who do not opt in to group support will only provide self-report data on their wellbeing and quality of life every 3 months for up to 12 months. Data collected through online survey platforms using validated questionnaires

Acceptance and Commitment Therapy (ACT) Group

EXPERIMENTAL

Only those who opt in to group support will be invited and allocated into treatment groups at random. Participants in this arm will be invited to 9 weekly ACT-informed therapy sessions involving core values identification, mindfulness practices and committed action plans. There will be homework in between sessions.

Other: Acceptance and Commitment Therapy

Interventions

Acceptance and Commitment Therapy OTHER

9 x two hour remote sessions (50 minutes activity + 20 minute break + 50 minutes activity). Acceptance and Commitment Therapy (ACT) is a third wave transdiagnostic cognitive-behavioural therapy that supports clients to adjust to current experiences and 'commit' to behaviours that are congruent with their personal values, in order to promote psychological well-being and prevent future mental health crisis. ACT uses a variety of experiential techniques to support this process including: mindfulness practices; exercises to identify personal values; commitment to goals for valued living.

Acceptance and Commitment Therapy (ACT) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Adults in the UK (at least 18 years old)
• At least 4 months post-stroke (no upper limit);
• 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.

Sponsors & Collaborators

• University of Manchester: lead
• The Stroke Association, United Kingdom: collaborator

Study Sites (1)

University of Manchester

Manchester, United Kingdom

Location

Related Publications (1)

• Patchwood E, Foote H, Vail A, Cotterill S, Hill G; WAterS PCPI Group; Bowen A. Wellbeing After Stroke (WAterS): Feasibility Testing of a Co-developed Acceptance and Commitment Therapy Intervention to Support Psychological Adjustment After Stroke. Clin Rehabil. 2024 Jul;38(7):979-989. doi: 10.1177/02692155241239879. Epub 2024 Mar 20.

  PMID: 38505946 RESULT

Related Links

• YouTube channel where interested parties can listen to and read a lay-friendly report on study findings
• Dr Emma Patchwood (Chief Investigator) Research profile

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction; Communication Disorders

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Emma Patchwood, PhD

  University of Manchester

  PRINCIPAL INVESTIGATOR

• Audrey Bowen, PhD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: * 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Model Details: * Eligible Stroke Survivors are recruited and asked to a) provide self-reports on their wellbeing every 3 months for up to 12 months; b) opt in or out of invitation to group-based support. * Those who consent only to a) form our COHORT arm who do not receive treatment. * Those who consent to both a) and b) form our INTERVENTION group. When sufficient numbers are recruited, they are offered the intervention (Acceptance and Commitment Therapy group) Groups are delivered over 9 weekly sessions and involve homework. This description was updated in May 2023 but to confirm: no active comparator / attention control arm (as originally plan) was included in the actual study

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: December 7, 2020
• Study Start: January 5, 2021
• Primary Completion: March 15, 2021
• Study Completion: May 1, 2023
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)