Clinical Trials Logo

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 32
Est. completion date September 2026
Est. primary completion date July 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Focus group
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
King's College London South London and Maudsley NHS Foundation Trust

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT04929938 - Application of UP for Transdiagnostic Treatment of Emotional Disorders for UHR for Psychosis Patients N/A
Recruiting NCT05863572 - Strengthening Care in Collaboration With People With Lived Experience of Psychosis in Uganda N/A
Completed NCT04277585 - Improving Access to Early Psychosis Coordinated Specialty Care N/A
Recruiting NCT06197048 - Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Terminated NCT04404712 - FAAH Availability in Psychiatric Disorders: A PET Study Early Phase 1
Recruiting NCT05769933 - Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
Recruiting NCT04298450 - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention N/A
Not yet recruiting NCT05558332 - Youth Nominated Support Team N/A
Not yet recruiting NCT05358457 - Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf) N/A
Not yet recruiting NCT03807388 - ReMindCare App for Patients From First Episode of Psychosis Unit. N/A
Completed NCT02895269 - COllaborative Shared Care to IMprove Psychosis Outcome N/A
Recruiting NCT02622048 - Understanding and Helping Families: Parents With Psychosis N/A
Completed NCT02733575 - Compassion Focused Therapy for Distressing Experiences N/A
Completed NCT02531243 - Computer-Aided Learning for Managing Stress N/A
Completed NCT02653729 - Cbt for Psychosis and Affect on Psychosis Symptoms Phase 2
Not yet recruiting NCT02244970 - Mindfulness RCT for Early Psychosis N/A
Enrolling by invitation NCT01364818 - Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment N/A
Withdrawn NCT00786318 - Ziprasidone vs Standard Therapy for Agitated Patients in the ED Phase 4
Recruiting NCT00722163 - A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis Phase 0