NCT04655937: WAterS

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

Completed Phase 1 Last updated 10 May 2024

What this trial tests

Phase 1 trial testing Acceptance and Commitment Therapy in Stroke in 20 participants. Completed in 1 May 2023.

Timeline

5 January 2021

Primary endpoint
15 March 2021

1 May 2023

Quick facts

Lead sponsor	University of Manchester
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	5 January 2021
Primary completion	15 March 2021
Estimated completion	1 May 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

• Acceptance and Commitment Therapy

Conditions studied

• Stroke — all drugs for Stroke →
• Psychological Distress — all drugs for Psychological Distress →
• Cognitive Dysfunction — all drugs for Cognitive Dysfunction →
• Communication Disorders — all drugs for Communication Disorders →

Sponsor

University of Manchester

Who can join

18 and older, any sex, with Stroke or Psychological Distress. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pharmacological, non-invasive brain stimulation and psychological interventions, and their combination, for treating depression after stroke.
   Allida SM, Hsieh CF, Cox KL, Patel K, et al · · 2023 · cited 11× · PMID 37417452 · DOI 10.1002/14651858.cd003437.pub5
2. Wellbeing After Stroke (WAterS): Feasibility Testing of a Co-developed Acceptance and Commitment Therapy Intervention to Support Psychological Adjustment After Stroke.
   Patchwood E, Foote H, Vail A, Cotterill S, et al · · 2024 · cited 10× · PMID 38505946 · DOI 10.1177/02692155241239879