Severe and Persistent Mental IllnessNCT07446140
Evaluating the Feasibility, Acceptability, and Initial Clinical Effectiveness of Implementing a Cognitive Remediation Program Within Psychiatric Services.
A study testing Cognitive remediation in people with Severe and Persistent Mental Illness, run by The Royal Ottawa Mental Health Centre.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe and Persistent Mental Illness
- What is being tested?
- Cognitive remediation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Intellectual disability diagnosis and confirmed in medical record.
- A major medical condition other than the mental health disorder that affects cognitive functioning.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Severe and Persistent Mental Illness
- Being tested
- Cognitive remediation
- Keywords
- Cognitive Remediation, Neurocognition, Social Cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive remediationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Attention and Executive Function | Experimental | Not described Receives: Other: Cognitive remediation |
| Memory | Experimental | Not described Receives: Other: Cognitive remediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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))
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.
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completionJan 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe and Persistent Mental IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal Ottawa Mental Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Synthia Guimond, The Royal Ottawa Mental Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446140
- Sponsor's protocol ID
- The Royal Ottawa Mental Health
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility, Acceptability, and Initial Clinical Effectiveness of Implementing a Cognitive Remediation Program Within Psychiatric Services.
- ClinicalTrials.gov ID
- NCT07446140
- Acronym / sponsor ID
- The Royal Ottawa Mental Health
- Conditions
- Severe and Persistent Mental Illness
- Keywords
- Cognitive Remediation, Neurocognition, Social Cognition
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- The Royal Ottawa Mental Health CentreUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention and Executive Function | Experimental | Other: Cognitive remediation |
| Memory | Experimental | Other: Cognitive remediation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Intellectual disability diagnosis and confirmed in medical record.
- A major medical condition other than the mental health disorder that affects cognitive functioning.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive remediationCognitive 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. | Other | Attention and Executive Function, Memory |
Primary outcome
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.
3 secondary outcomes
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))
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)
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))
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive remediation in people with Severe and Persistent Mental Illness, run by The Royal Ottawa Mental Health Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Synthia Guimond, PhD (613-722-6521 ext. 6599, synthia.guimond@theroyal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.