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Clinical Trials/NCT06032182
NCT06032182
Recruiting
Not Applicable

PSYCHE Cognitive Remediation & Social Recovery in Early Psychosis Study

National University of Ireland, Galway, Ireland5 sites in 1 country40 target enrollmentMarch 1, 2023
ConditionsEarly Psychosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Early Psychosis
Sponsor
National University of Ireland, Galway, Ireland
Enrollment
40
Locations
5
Primary Endpoint
Social and Occupational Functioning Assessment Scale
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This study is a pilot feasibility study embedded in the Early Intervention in Psychosis (EIP) services in Ireland. It explores the feasibility and acceptability of a combined cognitive remediation training and social recovery therapy intervention.

Detailed Description

The Cognitive Remediation and Social Recovery in Early Psychosis (CRESTR) study is a feasibility study recruiting participants from the Health Service Executive Early Intervention in Psychosis (EIP) services in Sligo, Meath and Cork and the Adult Mental Heath Service in Galway. This study explores the feasibility and acceptability of a novel, 15-week multicomponent psychosocial intervention which combines cognitive remediation training (CRT) and social recovery therapy (SRT). Primary and secondary outcome measures are described later in this registration. The intervention components include: Component 1: The CRT programme used in this study is the Computerised Interactive Remediation of Cognition- Training for Schizophrenia (CIRCuiTS). CIRCuiTS is a web-based CRT programme which targets metacognition, specifically strategy use, in addition to massed practice of cognitive functions (attention, memory and executive functioning). Collaborative goal setting related to real-world tasks are integral to the programme with the programme tasks and exercises increasing in difficulty in response to the participant's performance and progress. This will be the primary focus of 1:1 therapy for the first 7 weeks with remote practice sessions occurring between therapy visits. After 7 weeks remote practice will continue and the focus of in-person therapy sessions will bridge to social recovery therapy as detailed below. Component 2: Social recovery therapy (SRT) focuses on addressing barriers to individuals interacting in their social environment e.g., social anxiety. It is informed by cognitive behavioural theory and addresses individual goals. SRT follows an established protocol. In summary, this consists of therapy delivered in three stages. Stage one will include engagement and formulation with the purpose of identifying a problem list and establishing a therapeutic relationship. Stage two will include preparing for new activities with identification of pathways to activity and collaboration with community stakeholders. Stage three will include engagement in new activities using behavioural experiments to promote social activity. This is the primary focus of in-person therapy sessions from week 8 to 15 alongside remote practice of the CRT programme.

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
December 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gary Donohoe

Professor Gary Donohoe

National University of Ireland, Galway, Ireland

Eligibility Criteria

Inclusion Criteria

  • Aged between 18 and 60 years of age
  • Within the first 5 years of a diagnosed psychotic disorder
  • Community based and clinically stable
  • Ability to give informed consent

Exclusion Criteria

  • History of organic impairment
  • History of head injury with loss of consciousness \> 5-minute duration

Outcomes

Primary Outcomes

Social and Occupational Functioning Assessment Scale

Time Frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)

Social and Occupational Functional Assessment Scale (Rybarczyk, 2011) is a global rating of current functioning ranging from 0 to 100, with lower scores representing lower functioning.

Secondary Outcomes

  • The Bell Lysaker Emotion Recognition Task(T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up))
  • The matrix reasoning subtest from the Wechsler Adult Scale of Intelligence 3rd edition (WAIS-III)(T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up))
  • The Patient Health Questionnaire-9(T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up))
  • The Reading the Mind in the Eyes Task(T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up))
  • Emotion Recognition Task(T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up))
  • Test of Premorbid Functioning(T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up))
  • The Scale for the Assessment of Positive Symptoms and the Scale for the Assessment of Negative Symptoms.(T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up))
  • Letter Number Sequencing Task(T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up))
  • Metacognitive Awareness Scale, Domain Specific(T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up))
  • Drug Use Disorders Identification Test(T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up))
  • The Generalised Anxiety Disorder Assessment-7(T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up))
  • Alcohol Use Disorders Identification Test(T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up))
  • Global Functioning Scale(T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up))
  • Global Assessment of Function(T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up))
  • EQ-ED-EL Health Questionnaire(T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up))
  • MIRECC Global Assessment of Function(T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up))
  • Time Use Survey(T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up))

Study Sites (5)

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