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NCT Number: NCT07446140

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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).

    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.

  2. 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).

    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.

  3. 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).

    The Measure of Life Habits (MHAVIE) assesses functional capacity by placing participants in situations similar to those encountered in everyday life.

Other outcomes

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

    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 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.

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

    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 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.

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

    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 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Synthia Guimond, PhD

CONTACT

[email protected]

613-722-6521 ext. 6599

Sponsors and collaborators

Lead sponsor

The Royal Ottawa Mental Health Centre

Other

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.