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

NCT04655937 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-05-10

No results posted yet for this study

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

Conditions

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

Interventions

OTHER

Acceptance and Commitment Therapy

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.

Sponsors & Collaborators

  • The Stroke Association, United Kingdom

    collaborator OTHER
  • University of Manchester

    lead OTHER

Principal Investigators

  • Emma Patchwood, PhD · University of Manchester

  • Audrey Bowen, PhD · University of Manchester

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-05
Primary Completion
2021-03-15
Completion
2023-05-01

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04655937 on ClinicalTrials.gov