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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Royal Ottawa Mental Health Centre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Intellectual disability diagnosis and confirmed in medical record.

A major medical condition other than the mental health disorder that affects cognitive functioning.

Trial design

Design model

Single group

Treatments tested in this trial

  • Cognitive remediation

    Other intervention

    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.

Treatment groups

87 Participants
are divided into 2 treatment groups
Group A: Attention and Executive FunctionExperimental treatment 1 intervention
Group B: MemoryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).
2

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).
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))

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).
4

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).

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))

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).
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)

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).
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))

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).

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)

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).
2

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).
3

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).

Locations

This trial has no locations.

Sponsors and contacts

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