PSYCHE Cognitive Remediation & Social Recovery Study

National University of Ireland, Galway, Ireland

Status: Enrolling

Conditions: Early Psychosis

Treatments: Behavioral: CRESTR Control; Behavioral: CRESTR Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06032182

NUIRELAND2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Intervention

Experimental group

Description:

15 sessions of the combined cognitive remediation training and social recovery therapy intervention.

Treatment:

Behavioral: CRESTR Intervention

Control

Active Comparator group

Description:

15 sessions of social recovery therapy alone.

Treatment:

Behavioral: CRESTR Control