Clinical trial NCT06032182: PSYCHE Cognitive Remediation & Social Recovery Study
Official title: PSYCHE Cognitive Remediation & Social Recovery in Early Psychosis Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Early Psychosis
Keywords: Recovery
Cognitive remediation training
Cognitive behavioural therapy
Psychosis
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
Collaborators: name: Health Service Executive, Ireland
name: Health Research Board, Ireland
First posted: 2023-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* IQ\< 70
* History of head injury with loss of consciousness \> 5-minute duration

Primary outcomes:
measure: Social and Occupational Functioning Assessment Scale
timeFrame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
Secondary outcomes:
measure: The Reading the Mind in the Eyes Task
timeFrame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
measure: Emotion Recognition Task
timeFrame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
measure: The Bell Lysaker Emotion Recognition Task
timeFrame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
measure: Test of Premorbid Functioning
timeFrame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
measure: The matrix reasoning subtest from the Wechsler Adult Scale of Intelligence 3rd edition (WAIS-III)
timeFrame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
measure: Letter Number Sequencing Task
timeFrame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
measure: Metacognitive Awareness Scale, Domain Specific
timeFrame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
measure: The Scale for the Assessment of Positive Symptoms and the Scale for the Assessment of Negative Symptoms.
timeFrame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
measure: The Patient Health Questionnaire-9
timeFrame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
measure: The Generalised Anxiety Disorder Assessment-7
timeFrame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
measure: Drug Use Disorders Identification Test
timeFrame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
measure: Alcohol Use Disorders Identification Test
timeFrame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
measure: EQ-ED-EL Health Questionnaire
timeFrame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
measure: Global Functioning Scale
timeFrame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
measure: MIRECC Global Assessment of Function
timeFrame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
measure: Global Assessment of Function
timeFrame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
measure: Time Use Survey
timeFrame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: HSE Early Intervention in Psychosis Service, Cork
city: Dublin
country: Ireland
facility: DETECT Early Intervention in Psychosis Service
city: Galway
country: Ireland
facility: Adult Mental Health Service, University Hospital Galway
city: Navan
country: Ireland
facility: HSE Early Intervention in Psychosis Service, Meath
city: Sligo
country: Ireland
facility: HSE Early Intervention in Psychosis Service, Sligo
Study officials:
References: