NCT06042712

Brief Summary

Psychotic illnesses are characterised by hallucinations, delusions, and disturbed thoughts; symptoms associated with high personal and societal costs. Despite the efficacy of antipsychotic medication, approximately 84% of patients experience at least one relapse within 36 months of their first episode. Thus, identifying patients who will relapse and who will not, and then providing specific treatment to patients who are more likely to relapse is clinically meaningful. Belief-updating and speech are promising markers to predict first episode psychosis (FEP) patients future relapse outcome, as there has been evidence linking these two markers with the onset and progression of psychotic symptoms. The present study will collect cognitive measures relating to belief-updating and speech in patients with FEP at baseline, and build models to predict relapse based on these measures. Belief updating tasks include simple video games (escaping from a planet in the Space Task and a reversal learning task). To collect speech, participants will be asked to describe ambiguous pictures. The study uses a naturalistic follow-up design; data will be collected from 140 FEP patients recruited from local clinical teams and 100 healthy controls recruited from advertisements. Cognitive tasks will be conducted via an online platform Gorilla using participants' own device (e.g. computer, laptop, smartphone and tablet). Clinical interviews can take place either online or face-to-face. Participants will attend three assessments in total, at baseline and at 6-month and 12-month follow-up. Each visit will comprise two components 1) cognitive tasks (45-60 minutes) and basic demographics, 2) clinical interviews.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started May 2024

Longer than P75 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 Progress53%
May 2024Apr 2028

First Submitted

Initial submission to the registry

September 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

4 years

First QC Date

September 8, 2023

Last Update Submit

March 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Relapse

    Change in score on the Positive and Negative Syndrome Scale

    One year

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

People with a first episode of psychosis and matched controls

You may qualify if:

  • Participants will be recruited from two routes:
  • Participants who are part of Urban Mind study will be invited to the present study;
  • Patients who are referred to the following early psychosis teams will also be invited to the study: Lambeth Early Psychosis (LEO), Southwark Team for Early Psychosis (STEP), Lewisham Early Intervention Service (LEIS), Croydon Outreach Assessment Support Team (COAST), Central and North West London NHS Foundation Trust (NWLFT).
  • Participants from both routes will need to meet the following criteria:
  • all participants are 18 to 40 years old
  • all participants have an adequate command of the English language to complete the assessment
  • all participants need access to laptop, smartphone or computer to complete the tasks
  • all participants met FEP as defined by a DSM-IV diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, or delusional disorder based on the Structured Clinical Interview for DSM-IV (SCID-I) (First et al., 2002).

You may not qualify if:

  • Experienced more than one previous episode of psychosis
  • Any other neurological disorders that could potentially interfere with study process or patients' safety
  • Refusing to complete the belief-updating or speech tasks
  • Participants' answers are identified as fake answers or participants complete the tasks for multiple times (identified by their unique participants code).
  • Participants are unable to fully comprehend the purpose of the study or make a rational decision whether or not to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 18, 2023

Study Start

May 1, 2024

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Last Updated

March 6, 2024

Record last verified: 2024-03