PSYCHE Cognitive Remediation & Social Recovery Study

NCT ID: NCT06032182

Last Updated: 2024-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Early Psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

CRESTR Intervention

Intervention Type BEHAVIORAL

15 1-hour sessions of CRT + SRT

Control

15 sessions of social recovery therapy alone.

Group Type ACTIVE_COMPARATOR

CRESTR Control

Intervention Type BEHAVIORAL

15 1-hour sessions of SRT alone

Interventions

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CRESTR Intervention

15 1-hour sessions of CRT + SRT

Intervention Type BEHAVIORAL

CRESTR Control

15 1-hour sessions of SRT alone

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Health Service Executive, Ireland

OTHER

Sponsor Role collaborator

Health Research Board, Ireland

OTHER

Sponsor Role collaborator

National University of Ireland, Galway, Ireland

OTHER

Sponsor Role lead

Responsible Party

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Gary Donohoe

Professor Gary Donohoe

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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HSE Early Intervention in Psychosis Service, Cork

Cork, , Ireland

Site Status RECRUITING

DETECT Early Intervention in Psychosis Service

Dublin, , Ireland

Site Status RECRUITING

Adult Mental Health Service, University Hospital Galway

Galway, , Ireland

Site Status RECRUITING

HSE Early Intervention in Psychosis Service, Meath

Navan, , Ireland

Site Status RECRUITING

HSE Early Intervention in Psychosis Service, Sligo

Sligo, , Ireland

Site Status RECRUITING

Countries

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Ireland

Central Contacts

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Prof. Gary Donohoe

Role: CONTACT

0035391495122

Dr Emma Frawley

Role: CONTACT

0035391495953

Facility Contacts

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Dr Karen O'Connor

Role: primary

0035321 4233164

Mary Clarke, Prof.

Role: primary

Dr Brian Hallahan

Role: primary

0035391524222 ext. 4162

Dr Marie Whitty

Role: primary

Dr Donagh O'Neil

Role: primary

Other Identifiers

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NUIRELAND2

Identifier Type: -

Identifier Source: org_study_id

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