NCT06364241

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Jun 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Jun 2024Sep 2026

First Submitted

Initial submission to the registry

March 18, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

April 15, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

March 18, 2024

Last Update Submit

April 11, 2024

Conditions

Keywords

SchizophreniaBipolar disorderCognition

Outcome Measures

Primary Outcomes (1)

  • 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.

    Autumn 2024

Study Arms (2)

Individuals with lived experience of psychosis

Individuals with lived experience of psychosis

Other: Focus group

Carers of individuals with lived experience of psychosis

Carers of individuals with lived experience of psychosis

Other: Focus group

Interventions

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 psychosisIndividuals with lived experience of psychosis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychotic DisordersSchizophreniaBipolar Disorder

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Paola Dazzan, MBBS MSc PhD FRCPsych

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2024

First Posted

April 15, 2024

Study Start

June 1, 2024

Primary Completion

July 1, 2024

Study Completion (Estimated)

September 1, 2026

Last Updated

April 15, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share