PsychosisPRECOGNITIONNCT06364241
Focus Groups on Cognitive Function in Psychosis
An observational study of Psychosis, run by King's College London.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Focus group
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Individuals with lived experience with psychosis, including individuals with personal experience of psychosis, carers and family members
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Psychosis
- Being tested
- Focus group
- Keywords
- Schizophrenia, Bipolar disorder, Cognition
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with lived experience of psychosis | Individuals with lived experience of psychosis Receives: Other: Focus group | |
| Carers of individuals with lived experience of psychosis | Carers of individuals with lived experience of psychosis Receives: Other: Focus group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual perception of impairments due to cognitive deficits associated with psychosis
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.
Measured: Autumn 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study startJun 2024 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364241
- Sponsor's protocol ID
- 331760
- Other IDs
- 226706/Z/22/Z
- Acronym
- PRECOGNITION
- Status last verified
- Apr 2024
- First submitted
- 18 Mar 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focus Groups on Cognitive Function in Psychosis
- ClinicalTrials.gov ID
- NCT06364241
- Acronym / sponsor ID
- PRECOGNITION / 331760
- Conditions
- Psychosis
- Keywords
- Schizophrenia, Bipolar disorder, Cognition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with lived experience of psychosis | – | Other: Focus groupIndividuals with lived experience of psychosis |
| Carers of individuals with lived experience of psychosis | – | Other: Focus groupCarers of individuals with lived experience of psychosis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals with lived experience with psychosis, including individuals with personal experience of psychosis, carers and family members
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus groupDuring 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. | Other | Carers of individuals with lived experience of psychosis, Individuals with lived experience of psychosis |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Psychosis
RecruitingPhase 2
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Schizophrenia
RecruitingPhase 3
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Schizophrenia
Recruiting
Magnetic Seizure Therapy for Schizophrenia - Trial
Treatment Resistant Schizophrenia, Schizophrenia
RecruitingObservational study
Sensory Profile and Early Clinical Signs of Calm Room Users
Psychotic Disorders, Personality Disorders
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosis, run by King's College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Dazzan, MBBS MSc PhD FRCPsych (020 7848 0029 ext. +44, paola.dazzan@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individual perception of impairments due to cognitive deficits associated with psychosis (time frame: Autumn 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.