NCT06032182

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
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 Start

First participant enrolled

March 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

2.3 years

First QC Date

August 30, 2023

Last Update Submit

March 20, 2024

Conditions

Early Psychosis

Keywords

RecoveryCognitive remediation trainingCognitive behavioural therapyPsychosis

Outcome Measures

Primary Outcomes (1)

  • Social and Occupational Functioning Assessment Scale

    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.

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

Secondary Outcomes (17)

  • 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)

  • The Bell Lysaker 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 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)

  • +12 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: CRESTR Intervention

Control

ACTIVE COMPARATOR

15 sessions of social recovery therapy alone.

Behavioral: CRESTR Control

Interventions

CRESTR InterventionBEHAVIORAL

15 1-hour sessions of CRT + SRT

Intervention
CRESTR ControlBEHAVIORAL

15 1-hour sessions of SRT alone

Control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

HSE Early Intervention in Psychosis Service, Cork

Cork, Ireland

RECRUITING

DETECT Early Intervention in Psychosis Service

Dublin, Ireland

RECRUITING

Adult Mental Health Service, University Hospital Galway

Galway, Ireland

RECRUITING

HSE Early Intervention in Psychosis Service, Meath

Navan, Ireland

RECRUITING

HSE Early Intervention in Psychosis Service, Sligo

Sligo, Ireland

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Prof. Gary Donohoe

CONTACT

0035391495122gary.donohoe@universityofgalway.ie

Dr Emma Frawley

CONTACT

0035391495953emma.frawley@universityofgalway.ie

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Gary Donohoe

Study Record Dates

First Submitted

August 30, 2023

First Posted

September 11, 2023

Study Start

March 1, 2023

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

March 22, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

The full protocol in addition to datasets and statistical code generated during the current study will be available from the corresponding author on reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Access Criteria
The full protocol in addition to datasets and statistical code generated during the current study will be available from the corresponding author on reasonable request.

Locations

IE(5)