Evaluating the Feasibility, Acceptability, and Initial Clinical Effectiveness of Implementing a Cognitive Remediation Program Within Psychiatric Services.

NCT07446140 | Not Yet Recruiting

• 1 other identifier: The Royal Ottawa Mental Health
• Study Type: interventional
• Target: 87
• Locations: 0 countries
• Sites: N/A

Brief Summary

Severe and persistent mental health disorders are associated with impairments in cognitive, emotional, and social functioning. Some of these disorders involve cognitive challenges that are likely to negatively affect quality of life. In this context, the early identification of cognitive difficulties and intervention through cognitive remediation become priority therapeutic targets to facilitate individual rehabilitation. From this perspective, the present study aims to determine the relevance of a personalized cognitive remediation program developed by neuropsychologists at Pierre-Janet Hospital, called RECAMEX, to guide its sustainable adoption and to support its implementation in other clinical settings.

Conditions

Severe and Persistent Mental Illness

Keywords

Cognitive Remediation; Neurocognition; Social Cognition

Outcome Measures

Primary Outcomes (5)

• Feasibility will be assessed using the attrition rate, with rates above 30% indicating feasibility concerns.

  The attrition rate represents the percentage of participants who drop out during the study period. It is calculated by dividing the number of dropouts by the total number of participants and multiplying by 100.

  Data will be collected at each measurement time point : T0 (baseline assessment), T1 (pre-intervention assessment), T2 (1 week post-intervention assessment), and T3 (three-month post-intervention follow-up assessment).

• Program acceptability will be evaluated by assessing good therapeutic alliance. (Working Alliance Inventory Short Form (WAI-S)

  The Working Alliance Inventory-Short Form (WAI-S) is a 12-item self-report questionnaire that assesses the quality of the therapeutic alliance, using a 5-point Likert scale.

  Data will be collected at each measurement time point : T0 (baseline assessment), T1 (pre-intervention assessment), T2 (1 week post-intervention assessment), and T3 (three-month post-intervention follow-up assessment).

• The increase in neurocognitive scores between T1 and T2 is expected to be greater than the change observed between T0 and T1. (Hopkins Verbal Learning Test (HVLT))

  The Hopkins Verbal Learning Test (HVLT) assesses verbal learning and memory. A list of 12 words drawn from three different semantic categories is orally presented to participants across three learning trials, followed by an interference task and an immediate free recall.

  Data will be collected at each measurement time point : T0 (baseline assessment), T1 (pre-intervention assessment), T2 (1 week post-intervention assessment), and T3 (three-month post-intervention follow-up assessment).

• Program acceptability will be evaluated by assessing good treatment adherence. (Treatment Adherence Perception Questionnaire (TAPQ)).

  The Treatment Adherence Perception Questionnaire (TAPQ) is a 16-item self-report measure that evaluates participants' perceptions of the treatment, using a 5-point Likert scale.

  Data will be collected at each measurement time point : T0 (baseline assessment), T1 (pre-intervention assessment), T2 (1 week post-intervention assessment), and T3 (three-month post-intervention follow-up assessment).

• The increase in neurocognitive scores between T1 and T2 is expected to be greater than the change observed between T0 and T1. (the Cambridge Neuropsychological Test Automated Battery (CANTAB)).

  The Cambridge Neuropsychological Test Automated Battery (CANTAB) is a computerized neuropsychological assessment battery used to evaluate multiple cognitive domains.

  Data will be collected at each measurement time point : T0 (baseline assessment), T1 (pre-intervention assessment), T2 (1 week post-intervention assessment), and T3 (three-month post-intervention follow-up assessment).

Secondary Outcomes (3)

• Improvements in daily functioning between T1 and T2 are expected to be greater than those observed between T0 and T1. (the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0))

  Data will be collected at each measurement time point : T0 (baseline assessment), T1 (pre-intervention assessment), T2 (1 week post-intervention assessment), and T3 (three-month post-intervention follow-up assessment).

• Improvements in daily functioning between T1 and T2 are expected to be greater than those observed between T0 and T1. (the Social and Occupational Functioning Assessment Scale)

  Data will be collected at each measurement time point : T0 (baseline assessment), T1 (pre-intervention assessment), T2 (1 week post-intervention assessment), and T3 (three-month post-intervention follow-up assessment).

• Improvements in daily functioning between T1 and T2 are expected to be greater than those observed between T0 and T1. (The Measure of Life Habits (MHAVIE))

  Data will be collected at each measurement time point : T0 (baseline assessment), T1 (pre-intervention assessment), T2 (1 week post-intervention assessment), and T3 (three-month post-intervention follow-up assessment).

Other Outcomes (3)

• Self-reported measures of self-esteem/well-being are expected to show improvements between T1 and T2 than between T0 and T1(WEMWBS)

  Data will be collected at each measurement time point : T0 (baseline assessment), T1 (pre-intervention assessment), T2 (1 week post-intervention assessment), and T3 (three-month post-intervention follow-up assessment).

• Self-reported measures of functioning are expected to show improvements between T1 and T2 than between T0 and T1(SFQ)

  Data will be collected at each measurement time point : T0 (baseline assessment), T1 (pre-intervention assessment), T2 (1 week post-intervention assessment), and T3 (three-month post-intervention follow-up assessment).

• Self-reported measures of subjective cognitive functioning are expected to show improvements between T1 and T2 than between T0 and T1(CFQ-SF)

  Data will be collected at each measurement time point : T0 (baseline assessment), T1 (pre-intervention assessment), T2 (1 week post-intervention assessment), and T3 (three-month post-intervention follow-up assessment).

Study Arms (2)

Attention and Executive Function

EXPERIMENTAL

Other: Cognitive remediation

Memory

EXPERIMENTAL

Other: Cognitive remediation

Interventions

Cognitive remediation OTHER

Cognitive remediation differs from other interventions through its emphasis on cognitive processes, as well as through the teaching of compensatory strategies and/or the training of specific cognitive functions. It aims to address the underlying cognitive deficits associated with the pathology, which undermine the individual's functioning in daily life. Cognitive remediation is an intervention targeting cognitive functions through the administration of repeated cognitive exercises with a gradually increasing level of difficulty.

Attention and Executive Function; Memory

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older.
• Present cognitive difficulties in the context of a diagnosed severe and persistent mental illness.
• Report recurrent complaints related to cognitive challenges affecting multiple areas of daily functioning.
• Able to provide free and informed consent.
• Fluent in French.
• Clinically stable (No change in psychotropic medication for at least one month).

You may not qualify if:

• Intellectual disability diagnosis and confirmed in medical record.
• A major medical condition other than the mental health disorder that affects cognitive functioning.

Sponsors & Collaborators

• The Royal Ottawa Mental Health Centre: lead

MeSH Terms

Interventions

Cognitive Remediation

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Synthia Guimond, PhD

CONTACT

613-722-6521; synthia.guimond@theroyal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: March 3, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: De-identified data will become available upon completion of the study and once results have been published in an academic journal (anticipated year of publication: 2029).
• Access Criteria: Upon request to Synthia Guimond