Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06364241 |
| Other study ID # |
331760 |
| Secondary ID |
226706/Z/22/Z |
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 2024 |
| Est. completion date |
September 2026 |
Study information
| Verified date |
April 2024 |
| Source |
King's College London |
| Contact |
Paola Dazzan, MBBS MSc PhD FRCPsych |
| Phone |
020 7848 0029 |
| Email |
paola.dazzan[@]kcl.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Cognitive deficits are commonly observed in people with mental disorders. In psychosis, these
impairments are frequently present early in the course of the disorder and have a substantial
impact on functional outcomes. This project will gain insight into the cognitive deficits
that people with lived experience of psychosis and their carers perceive to be the most
troublesome. To achieve this, the investigators will conduct two sets of focus groups. During
the first set of focus groups, the investigators will aim to identify the cognitive deficits
that individuals with psychosis and their carers consider to be the most impairing.
The findings of these focus groups will provide important information about what areas of
cognition and functioning should be considered in future analyses of large fully anonymised
datasets collected in the past from individuals with psychosis. The focus groups will not
form part of those analyses, but will provide input from people with lived experience of
psychosis on what problems with thinking skills are the most important for them and that
should be considered by further research.
The second set of focus groups will enable the investigators to determine the participants'
perception of potential risks and benefits associated with the dissemination of findings on
cognitive function in psychosis, to ensure this is done in a manner that is sensitive to the
wishes and needs of people with lived experience of psychosis.
Each participant will be asked to attend one focus group, which will last approximately one
hour. Focus groups will take place at the South London and Maudsley (SLaM) Trust or at the
Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London, although
provision will be made for participants to also participate online.
Description:
Design The investigators will conduct two sets of focus groups (2 focus groups at the
beginning and 1 or 2 focus groups at the end of the project) with a total of 6-8 participants
each. Focus groups will include either with people with lived experience with psychosis or
carers of people with lived experience with psychosis.
Timetable Attempts to contact participants will begin as soon as ethical approvals are in
place. It is expected that data collection will be completed over a 4-6-month period.
Interpretation and analysis of findings and preparation of the final report will be completed
by 30/09/2026.
Methodology Each focus group will last approximately one hour and will be conducted by a
research group member with relevant expertise. The focus groups will be held in-person at the
Institute of Psychiatry, Psychology and Neuroscience (IoPPN) Main Building, King's College
London, although provision will be made for participants to also participate online via
Microsoft Teams. The focus groups will be conducted in close temporal proximity one to
another. The focus groups will be facilitated by project staff, including project members
with lived experience of psychosis. Participants will be reimbursed for their time in
participating in the focus groups and for their travel expenses to attend. The focus groups
will be recorded (audio only) with participants' informed consent. Focus group data will be
transcribed verbatim by a professional transcription company.
The first set of focus groups will explore the cognitive deficits that people with lived
experience of psychosis or their carers consider to be the most impairing. The second set of
focus groups will discuss the results that emerge from this project, paying particular
attention to the participants' views on both the risks and potential opportunities derived
from our project, including recommendations regarding future stages of research. The
investigators will also discuss the best way to present findings to the wider scientific
community and lay audiences.
For each set of focus groups, thematic analysis will be conducted to order data into
meaningful patterns. Thematic analysis will include inductive and deductive coding to ensure
that analysis is shaped by participants' concerns and priorities, and allow the investigators
to systematically probe the data, asking questions arising from the existing literature.
Thematic analysis will be performed using the Atlas.ti software, which is an industry
standard for both deductive and inductive analyses. Finally, the findings from the focus
groups will be disseminated via publications prepared with input from the lived experience
experts.
