NCT07446140

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

Not yet recruiting NA Last updated 25 February 2026

What this trial tests

NA trial testing Cognitive remediation in Severe and Persistent Mental Illness in 87 participants. Not yet recruiting.

Timeline

1 March 2026

Primary endpoint
1 January 2029

1 March 2029

Quick facts

Lead sponsor	The Royal Ottawa Mental Health Centre
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	87
Start date	1 March 2026
Primary completion	1 January 2029
Estimated completion	1 March 2029

Drugs / interventions tested

• Cognitive remediation — full drug profile →

Conditions studied

• Severe and Persistent Mental Illness — all drugs for Severe and Persistent Mental Illness →

Sponsor

The Royal Ottawa Mental Health Centre — full company profile →

Who can join

18 and older, any sex, with Severe and Persistent Mental Illness. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Feasibility will be assessed using the attrition rate, with rates above 30% indicating feasibility concerns.
  Time frame: 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 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.
• Program acceptability will be evaluated by assessing good therapeutic alliance. (Working Alliance Inventory Short Form (WAI-S)
  Time frame: 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 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.
• 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))
  Time frame: 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 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.
• Program acceptability will be evaluated by assessing good treatment adherence. (Treatment Adherence Perception Questionnaire (TAPQ)).
  Time frame: 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 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.
• 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)).
  Time frame: 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 Cambridge Neuropsychological Test Automated Battery (CANTAB) is a computerized neuropsychological assessment battery used to evaluate multiple cognitive domains.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.