An interventional study of Cognitive remediation in Severe and Persistent Mental Illness, sponsored by The Royal Ottawa Mental Health Centre. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by The Royal Ottawa Mental Health Centre · Not applicable, Interventional, and Treatment
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.
We propose a within-subject clinical trial with a control wait-list period to evaluate the effects of a cognitive remediation intervention targeting executive functions in adults living with a mental health disorder.
Participants will complete a baseline assessment (T0) consisting of a 50-minute initial interview and a first 90-minute assessment visit. The initial interview aims to identify the goals of participants and the variables likely to interact with the rehabilitation process. The first assessment will identify the strengths, weaknesses, and challenges using neuropsychological tests and standardized questionnaires to determine which module each participant will take part.
Participants will then enter a three-week waiting period during which they will not receive any study-related intervention. This waiting period will allow for control of practice effects and the establishment of an intra-individual baseline on outcome measures in the absence of intervention. At the end of this period, participants will complete a pre-intervention assessment (T1), followed by participation in a group cognitive remediation program consisting of six to eight sessions of approximately 90 minutes each, delivered at a frequency of one session per week. Each group will consist of approximately 6-8 participants and two neuropsychologists. A post-intervention assessment will be conducted at the end of the program (T2), followed by a follow-up assessment three months later (T3) to evaluate the maintenance of effects. Each assessment visit will last approximately 90 minutes.
At each measurement time point (T0, T1, T2, and T3), participants will complete a series of questionnaires to assess changes in various cognitive, functional, and social domains.
The intervention will take place in a clinical setting where neuropsychologists work at Pierre-Janet Hospital. Outcome assessments at T0, T1, T2, and T3 (pre- and post-intervention) will be conducted at Pierre-Janet Hospital whenever possible, and at the Cognitive Remediation and Neuroimaging Laboratory at the Université du Québec en Outaouais when necessary.
For the qualitative analysis following T3 (three-month follow-up assessment), semi-structured interviews lasting 30-45 minutes will be conducted with key project stakeholders. These interviews will allow for a thematic analysis aimed at evaluating the barriers and facilitators of implementing the RECAMEX program at Pierre-Janet Hospital.
Exclusion Criteria:
Other: Cognitive remediation
Other: Cognitive remediation
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.
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.
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).
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.
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 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.
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).
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.
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 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.
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).
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))
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) assesses functioning across six domains. 12 items rated on a 5-point Likert scale ranging from 0 to 5.
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).
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)
The Social and Occupational Functioning Assessment Scale (SOFAS) provides measure of an individual's social and occupational functioning. Scores range from 0 to 100 in 10-point intervals.
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).
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))
The Measure of Life Habits (MHAVIE) assesses functional capacity by placing participants in situations similar to those encountered in everyday life.
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).
Self-reported measures of self-esteem/well-being are expected to show improvements between T1 and T2 than between T0 and T1(WEMWBS)
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) consists of 14 items rated on a 5-point Likert scale. It assesses psychological well-being in individuals aged 13 to 74 years.
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).
Self-reported measures of functioning are expected to show improvements between T1 and T2 than between T0 and T1(SFQ)
The Social Functioning Questionnaire (SFQ) consists of 16 items rated on a 5-point scale. It includes eight frequency (F) items and eight satisfaction (S) items, each scored from 1 to 5, yielding total scores ranging from 8 to 40.
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).
Self-reported measures of subjective cognitive functioning are expected to show improvements between T1 and T2 than between T0 and T1(CFQ-SF)
The Cognitive Failures Questionnaire - Short Form (CFQ-SF) includes 25 items rated on a scale from 0 to 4. It is used to identify cognitive domains requiring targeted intervention.
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).
No study locations are listed for this record.
Plan to share: Yes — De-identified data collected from this study may be shared with other researchers at the Royal's Institute of Mental Health Research for analyses and re-analyses. Variables of the study and scripts used for analyses will be made available to the public. De-identified data will also be shared with the public upon request.
Supporting information: Study protocol, Sap, Icf, Analytic code
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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The Royal Ottawa Mental Health Centre