Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05402358 |
| Other study ID # |
274421 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2020 |
| Est. completion date |
November 30, 2021 |
Study information
| Verified date |
November 2023 |
| Source |
University of Stirling |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Does a group programme already delivered in routine practice to patients who share a
diagnosis from the same medical speciality (i.e. specific-diagnosis) show equal effectiveness
when modified for patients with diagnoses from a range of medical specialities (i.e.
mixed-diagnosis)?
A large number of people live with a long-term condition (LTC) and the burden of living with
a LTC is recognised on a societal and individual level. Links between LTCs and poorer mental
health increase demand on psychological services. Consequently new initiatives try to reduce
waiting times and increase the capacity of these services. Group programmes use resources
efficiently and have been applied across a range of medical specialities. A clinical health
psychology service has adopted a group programme based on a well evidenced psychological
therapeutic approach called Acceptance and Commitment Therapy (ACT), for patients with
dermatology conditions showing promising outcomes. However, the investigators want to compare
whether similar outcomes can be achieved with patients from a range of specialities.
The investigators conducted quantitative and qualitative research to answer the research
questions a) Does an Acceptance and Commitment Therapy group intervention for
specific-diagnosis groups suggest similar effectiveness in health-related quality of life,
illness beliefs and psychological distress versus mixed-diagnosis groups? b) Is there a
difference in feasibility and acceptability of an Acceptance and Commitment Therapy
intervention between specific-diagnosis groups versus mixed-diagnosis groups? c) What are
health professionals' views on the acceptability and feasibility of specific-diagnosis versus
mixed-diagnosis groups and their experiences of working with patients who have attended such
groups?
Participants were recruited from the Clinical Health Psychology waiting list at a UK NHS
Trust. Participants attended 7, two-hour weekly sessions and an 8 week follow-up 'reunion',
and completed health related quality of life, illness perceptions, depression and anxiety
questionnaires pre and post intervention. Patient participants and health professional
participants (facilitators and referrers) were invited to attend focus groups to discuss
their views and experiences.
Description:
Design
A mixed methods pilot and feasibility study was selected and applied. Mixed methods were
selected as it integrates rich and comprehensive data from a quantitative and qualitative
approach, to answer the overall studies research questions:
1. Is there a difference in feasibility and acceptability of an online ACT intervention
between specific-diagnosis versus mixed-diagnosis groups?
2. What are health professionals' views on the acceptability and feasibility of
specific-diagnosis versus mixed-diagnosis groups and their experiences of working with
patients who have attended such groups?
3. Do the results of this small pilot and feasibility study suggest similar effectiveness
in health-related quality of life, illness beliefs and psychological distress in
specific-diagnosis versus mixed-diagnosis groups? We delivered online groups.
Quantitative data collected from attendance records, and qualitative data collected from
qualitative interviews with participants who took part in the intervention, addressed
research question 1. Qualitative data collected from qualitative interviews with health
professionals who facilitated the intervention, and health professionals who referred
patients to the intervention, addressed research question 2. Finally, quantitative data
collected from psychometric measures, addressed the third research question.
Study participants
Patient participants were recruited from the Clinical Health Psychology GM team waiting list,
or by being made aware of the groups by health professionals working within specialities
covered by the GM team. As per routine clinical practice, patients on the waiting list were
invited to attend the group intervention via letter or during a routine waiting list check-in
review. The waiting list was regularly reviewed so for each scheduled group, only new
appropriate patients on the waiting list were sent invites (i.e., each patient only received
one invite to respect their choice not to participate).
We had planned for potential patient participants to be able to self-refer to the clinical
team. Self-referrals were expected from patients who saw an advertising poster placed in the
waiting rooms of the hospital specialties the GM team covered. Since face-to-face healthcare
was extremely limited during the recruitment period, posters were not used.
All interested participants received a telephone screening consultation, including a brief
psychological assessment, to check each participant was suitable and that they met inclusion
criteria. This assessment informed patients about the research study in line with details
provided in the participant information sheet.
If after this telephone screening assessment with a clinical team member a participant met
the inclusion criteria, and wished to continue, they were allocated to the intervention and
invited into one of the group conditions, dependent on their diagnosis. Written consent was
obtained at the start of the intervention.
The group intervention was still offered to any patient who did not want to take part in the
research. If a patient was not suitable, they were offered appropriate alternative treatment
as deemed necessary by the assessing clinician.
At the last session of the intervention, patient participants recruited to the research were
invited via email to take part in a qualitative interview to explore their views and
experiences.
Two types of health professional participants were recruited:
(A) Those who facilitated/delivered the intervention (B) Those who referred patients to the
intervention Facilitators were invited via email to take part in an online focus group, and
referrers were invited via email to take part in online individual interviews. These explored
health professional participants views of the intervention and experiences of working with
patients in relation to the groups. The only facilitator who was excluded from participating
was the main researcher due to potential researcher bias. All health professional
participants were informed about the research study and given a participant information
sheet, prior to consenting to take part.
Procedure
The online ACT group intervention was delivered to two group conditions, specific-diagnosis
and mixed-diagnosis. Each group condition had four intervention group programmes, totaling
eight groups overall. Prior to the COVID-19 pandemic it was standard practice to deliver
groups face-to-face, however, government enforced restrictions meant that this was not
allowed particularly during national lockdowns. Hence the delivery format was changed to
online.
The ACT group intervention was called 'Living Well with a Long-Term Condition' and was
adapted from the Brassington et al., (2016) 'Better Living with Illness' protocol. A
clinician handbook, and participant workbook , was developed that could be used for both
group conditions. These materials were adapted by the researcher and other members of the GM
team, all of whom had received specialist training in ACT. Each group was delivered online
using a platform called 'Microsoft Teams'. The intervention was facilitated by two qualified
clinicians. The intervention consisted of 8, 2-hour sessions. Sessions 1-7 were delivered on
a weekly basis, followed by a gap of 8 weeks, before the final 'reunion' session. In summary
the sessions covered the six core processes of ACT, included experiential exercises, and
allowed for group discussions to share experiences and learning between participants.
Online 'screen share' materials were developed so that facilitators could guide participants
through the session content. Microsoft teams had features that were utilised to support the
group sessions such as camera, mute, raise hand, text chat and share screen functions.
Participants were encouraged to have their camera on during group sessions, but it was not
mandatory (to respect privacy and confidentiality). At the end of the sessions, facilitators
remained logged into the meeting for 15 minutes, to allow for any participants to answer
questions privately. Telephone calls were also offered, should any participants have any
questions which could be requested via email. Summary emails were sent following each session
which included links to access any exercises as part of their home-practice between sessions.
Participants who missed sessions were signposted to read through information provided in
their participant workbook and offered a telephone consultation to talk through any missed
content. It was decided that if anyone missed the first two sessions consecutively, they were
transferred to the next mixed-diagnosis group available or returned to the waiting list. This
decision was based on the potential to cause disruption to the group dynamics, whereby social
relationships would likely have already been established, making it difficult for a new
person to interact with the group and feel part of the 'group spirit', which may also
negatively impact a patient's own wellbeing. Unfortunately, resources did not allow multiple
specific-diagnosis groups to run hence the option to transfer to another specific-diagnosis
group was not possible.
Measures
Psychometric questionnaires were completed by patient participants to assess psychological
distress, illness perceptions and health-related quality of life at three different
timepoints, baseline (pre-treatment), session 7 (post-treatment) and session 8 (8-week
follow-up).
Other quantitative measures to assess the feasibility and acceptability of the intervention
to the patient participants included eligibility, recruitment, retention, true completion,
and intervention adherence rates.
We collected qualitative data with patient participants and health professional participants.
Patient qualitative interviews
Patient participants who had consented to take part in the research were invited via email to
take part in online focus groups and individual interviews using microsoft teams. These were
moderated by a research assistant who had an honorary contract as a volunteer assistant
psychologist with the Clinical Health Psychology service. The research assistant was provided
with training on how to conduct focus groups and individual interviews, and was supervised by
the main researcher, who had prior qualitative research experience. Originally four focus
groups were planned, two for each of the group conditions. To improve recruitment an
amendment to the ethics was approved (20/NW/0125/AM01), to include individual interviews as
well as focus groups to collect qualitative data from any participants who had been unable to
take part in focus groups. Both interviews and focus groups are an evidenced based method of
data collection for qualitative studies (Harrell & Bradley, 2009), the pros and cons for both
were considered, and it was concluded that this additional alternative method of data
collection allowed for greater flexibility to arrange interviews at times to suit all
participants busy schedules.
Participants were invited via email by the researcher and were given a participant
information sheet. Those who took part provided written consent. All qualitative interviews
were audio-recorded, focus groups lasted no longer than 2 hours and individual interviews
lasted no longer than 30 minutes. A topic guide was used to elicit participants views and
experiences of taking part in the intervention, as well as thoughts on the intervention being
delivered to the two group conditions.
Health professional interview
One focus group was conducted with the facilitators of the intervention. Individual
interviews were conducted with the referrers. All qualitative interviews were held online
using microsoft teams and moderated by the same research assistant as above. All health
professionals were invited via email and given participant information sheets explaining that
the focus group would last no longer than one hour and individual interviews no longer than
30 minutes. Two topic guides were developed, to gather the views and experiences of health
professionals including their thoughts on the two group conditions. All health professionals
who agreed to take part provided written consent and all qualitative interviews were
audio-recorded.
Quantitative data
A mixed 2 by 3 ANOVA analysis was used, to compare the mean differences between groups on the
outcome measures. These were split on a between subjects' factors (group condition), and a
within subjects' factor (time, with three timepoints; T1-baseline, T2-post treatment and T3-8
weeks follow-up), with data assessed for homogeneity, normality and sphericity, and
appropriate adjustments made when assumptions were violated.
Descriptive statistics reported eligibility, recruitment, retention, true completion, and
intervention adherence rates.
Qualitative data
Qualitative data was analysed aligned to a deductive and inductive, reflexive thematic
analysis approach (Braun & Clarke, 2006; 2019, 2020). This commonly used hybrid approach was
deemed appropriate, to best meet the aims of the study and answer research questions.
Initially a theory-driven concept, the TFA , was applied for the process of deductive
thematic analysis. Following this an inductive approach allowed the development of themes
from the data and allowed for a broader understanding of the data. It is acknowledged that
the coding approach was collaborative (as it involved multiple researchers) and reflexive
whereby researchers' 'read' the data based on personal theoretical assumptions, analytic
resources and skill. Thus, interpretations reflect those of the researchers' own experiences,
beliefs and biases which will have affected the development and generation of themes and
inferences.
