Focus Groups on Cognitive Function in Psychosis (PRECOGNITION)

April 11, 2024 updated by: King's College London

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Individuals with lived experience with psychosis, including individuals with personal experience of psychosis, carers and family members

Description

Inclusion Criteria:

  • Lived experience with psychosis, including individuals with personal experience of psychosis, carers and family members
  • Current or past cognitive deficits
  • Age between 18 and 65 years
  • Able to provide informed consent

Exclusion Criteria:

  • No lived experience with psychosis
  • Traumatic brain injury
  • Neurological or metabolic disorders associated with cognitive deficits
  • On occasions where it is not possible for the protocol to be followed, i.e. due to language barriers, participants will not be consented into the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Individuals with lived experience of psychosis
During the focus group, the investigators will explore the cognitive deficits that people with lived experience with psychosis and their carers consider to be the most impairing.
Carers of individuals with lived experience of psychosis
During the focus group, the investigators will explore the cognitive deficits that people with lived experience with psychosis and their carers consider to be the most impairing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual perception of impairments due to cognitive deficits associated with psychosis
Time Frame: Autumn 2024
For each set of focus groups, thematic analysis will be conducted to identify the main cognitive deficits that people with lived experience with psychosis consider to be the most impairing, including deficits in working memory, executive function and attention. No structured scales or questionnaires will be used.
Autumn 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

April 11, 2024

First Posted (Estimated)

April 15, 2024

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 331760
  • 226706/Z/22/Z (Other Grant/Funding Number: Wellcome Trust)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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