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

Overview

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.

Interventions

• 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 gradual

Primary outcome measures

• 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).]
• 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 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).]
• 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 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).]

Secondary outcome measures (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)) [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).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07446140 · The Royal Ottawa Mental Health

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗