Stroke Clinical Trial
Official title:
A Mixed-methods Evaluation of an Adapted Acceptance and Commitment Therapy (ACT) Group for Stroke Survivors and Their Carers: ACTivate Your Life After Stroke
Stroke is one of the main causes of acquired adult disability in the UK. Many psychological
problems can also occur post-stroke; this has a marked impact on health service usage. As
such, there is an outstanding need to increase and improve psychological resources within
stroke services.
The investigators proposed to adapt and evaluate the effectiveness of an acceptance and
commitment therapy (ACT) group intervention for adult stroke survivors and their carers. The
group will endeavour to promote positive adjustment and reduce levels of depression and
anxiety.
This study will have two parts.
Stroke is one of the main causes of acquired adult disability in the UK. In England and
Wales, over 900,000 people are living with the chronic illness, which can cause sufferers to
be highly dependent on others for their care. Many psychological problems can also occur
including: depression, anxiety and fatigue. This has a marked impact on health service usage.
There is an outstanding need to increase and improve psychological resources within these
services.
Acceptance and Commitment Therapy (ACT) has a well-established evidence base for reducing
psychological distress in individuals with mental illness and physical health conditions
including: diabetes, chronic pain, epilepsy & cancer. It is hoped that the investigators can
apply this same model to support stroke survivors and their carers.
The investigators propose to evaluate the effectiveness of an adapted ACT group intervention
for adult stroke survivors and their carers. The benefit of ACT is that it is transdiagnostic
therefore applicable to the very wide range of psychological problems found in carers and
survivors after stroke. This ACT group is a stroke adapted version of the already existing
'ACTivate your life' course, which is being run by the NHS for people with mental health
difficulties across South Wales. The course endeavours to promote positive adjustment and
reduce levels of depression and anxiety, using the core tenets of ACT.
This study will have two parts. Part 1: a quantitative phase evaluating the effectiveness of
the ACT group using outcome data in comparison to a waiting list control across three time
points. Part 2: A qualitative phase exploring stroke survivors experiences of the ACT group
and their perceptions of any change from group attendance.
PART 1:
Design: The study will employ a longitudinal randomised design using a questionnaire
methodology. The study will not be blind. Outcome measures will be taken pre, post and at a
two month follow up.
Participants and Recruitment: Participants will be recruited across five NHS University
Health Boards/Trusts: Cardiff and Vale University Health Board, Aneurin Bevan university
health board, Cwm Taf University Health Board, North Bristol NHS Trust and University
Hospitals Bristol NHS Foundation Trust. Bristol Area Stroke Foundation charity (BASF) will
also assist in the recruitment across Bristol and will host the course for all Bristol
participants. The individuals may be recruited at any stage of the care pathway after
discharge from hospital.
Potential participants will be identified by clinicians working within the stroke teams. All
interested participants will be provided with a course flyer, written participant information
sheet and consent form. Once consent has been obtained, participants will be randomly
allocated into the treatment group or placed on a waiting list (control group). Carer/stroke
survivor pairs will be allocated together. Participants who were allocated into the waiting
list group initially, will be offered to attend the ACT group once the first group has
finished and 2 month follow-up data has been collected.
The intervention group will attend a four week, 2.5 hour (maximum) psycho-educational group
that focuses on assisting stroke survivors and carers to learn a set of simple, and
teachable, techniques that focuses on changing patterns of experience and thinking. The
learning will involve understanding the principles of ACT via PowerPoint presentations which
have been adapted to include stroke specific examples and have been simplified to allow for
potential cognitive impairment.
Sample Size: In order for sufficient power (0.80) and using standard parameters of alpha =
0.05, a total sample size of between 40 - 64 participants are required in total.
Control Group: After the intervention group is finished, the waiting list group will be
offered the intervention which will consist of the exact same process as above.
Data Protection: Data will be anonymised with randomly allocated codes. Identifiable personal
data will be stored separately in a locked unit.
Analysis: A mixed model (within and between participants) MANOVA will be looking for group x
time interaction between the experimental and control.
PART 2:
Design: Semi-structured interviews will be conducted to explore stroke survivors' subjective
experiences of the ACT group. These will be conducted >1 month after the group and will be
framed around 8 main questions. Interviews will be undertaken in consultation rooms or in the
participants' own home, lasting no more than 1 hour. The number of interviews conducted will
depend upon the length of time it takes to reach data saturation (i.e. when no new
information is emerging from the dataset), which is recommended for the type of qualitative
analysis being performed. Interviews will be audio-recorded to support the researcher with
transcription and data analysis. Participants will be made aware of this in advance on the
consent form.
Sample Size: The investigators envisage data saturation will be achieved anywhere between 12
- 25 participant interviews.
Sampling: Sampling will begin purposefully in the first instance to offer maximum variation
in stroke survivors reported experiences of the group i.e. a diverse range of participants
who expressed interest to partake will be interviewed. Theoretical sampling will then be used
for subsequent interviews, whereby participants are selected based on the emerging theory.
Recruitment: Similar to above, participants will be recruited from the University Health
Boards (UHBs) and BASF charity, at any stage of the care pathway following discharge.
Participants for this phase of the study will consist only of stroke survivors.
Data Protection: All data will be stored on a password protected and encrypted USB device for
the duration of the study, and will subsequently be destroyed after use. Participants will be
assigned a numerical identifier during transcription to protect their identity.
Analysis: Grounded Theory (GT) will be used in phase 2, for both data collection and analysis
which will occur simultaneously. GT aims to identify emerging themes from the data and
develop new, contextualised theories (i.e. "grounded" in the data). As such, data collected
after each interview will be transcribed and reviewed in an evolving process. Interview
questions will be revised to progressively focus on the emerging theory. This process is in
line with the inductive nature of the GT approach.
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