Implementing Action-Based Cognitive Remediation for Transdiagnostic Cognitive Difficulties in a Tertiary Mental Health Hospital

Psychiatric conditions are each defined by different set of symptoms, however, they often share common characteristics such as impairments in cognitive and social functioning. These impairments can cause significant distress and disrupt daily functioning by preventing individuals from actively participating in school or work, maintaining healthy relationships with others, and engaging in everyday activities independently. The goal of this clinical trial is to examine if action-based cognitive remediation (ABCR) therapy, a type of cognitive training program, works to treat cognitive impairments in participants with psychiatric disorders.

The main questions it aims to answer are:

• Whether the intervention will improve the thinking skills of participants with different types of psychiatric conditions
• Whether the intervention will improve social skills and work performance
• Can this program be easily used in a regular hospital, and do the people who take part in it find it helpful and worth their time
• Whether the improvements from the intervention last for a long time after the training is over.

Researchers will compare how much the thinking skills of participants change during an 8-week waiting period (where they get no treatment) to how much they change during the 8-week training program to see if the training makes a bigger difference in helping them think and live better.

Participants will :

• Complete a series of questionnaires on memory, thinking skills, and mental health at the beginning of the study
• Wait 8 weeks without any intervention or training
• Complete the series of questionnaires again
• Complete an 8-week training intervention of ABCR where they will use special computer programs to practice real-life skills and tasks like planning a meal or making an appointment
• Complete the series of questionnaires and an additional structured interview to assess acceptability and feasibility of the intervention.
• 3 month later, complete questionnaires for a final time.

Study Overview

• Status: Not yet recruiting
• Conditions: Bipolar and Related Disorders; Autism Spectrum Disorder; Psychiatric Disorders; Depression - Major Depressive Disorder; Schizophrenia and Other Psychotic Disorders; Anxiety and Mood Disorders; PTSD - Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Action-Based Cognitive Remediation

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yasmine Tiraoui-Elkhoumri, BA; Phone Number: 6599 613-722-6521; Email: ytiraoui@theroyal.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants must have been given a diagnosis of a psychiatric disorder (such as mood anxiety, psychotic disorders, etc.
• Participants must have reported subjective cognitive difficulties associated with their psychiatric disorder
• Participants must be capable of providing informed consent
• Participants must have the ability to speak and read in either English or French
• Participants must have no changes to their medication intake (such as starting or stopping medication or changing doses) within the past month before providing consent for participation

Exclusion Criteria:

• Participants will be excluded if they are hospitalized at the time of recruitment
• Participants will be excluded if they have a confirmed diagnosis of an intellectual disability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Action-Based Cognitive Remediation (ABCR) with Waitlist Control Period

Behavioral: Action-Based Cognitive Remediation; Action-Based Cognitive Remediation (ABCR) is a type of cognitive remediation therapy, an intervention that focuses on mitigating cognitive deficits to enhance everyday functioning through behavioural learning strategies. The goal of ABCR is to increase real-world transferability of cognitive skills onto daily functioning through group discussions and computerized exercises. ABCR programs typically last 10 weeks with 2-hour sessions usually twice per week. Participants get placed into groups of 4-6 people with two therapists. Each session involves computer-based exercises and group discussion of cognitive strategies related to the theme of the day. Participants then role-play everyday functional tasks (e.g., meal planning, scheduling appointments) that reflect the focus of the session. Sessions conclude by linking content to individual goals and identifying cognitively challenging daily activities to practice between sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in neurocognitive performance from baseline to post-intervention, relative to change observed during the 8-week wait-list period (Screen for Cognitive Impairment in Psychiatry)	Investigators will assess cognitive functioning using the Screen for Cognitive Impairment in Psychiatry, from which a composite score will be calculated to represent overall cognitive performance. The test is comprised of five subscales: the Verbal Learning Test scores range from 0-30, the Working Memory Test scores range from 0-24, the Verbal Fluency scores represent number of correct responses with no fixed maximum score, the Verbal Learning Test-Delayed scores range from 0-10, the Processing Speed Test scores range from 0-30.	Participants complete the Screen for Cognitive Impairment in Psychiatry at baseline, 1 week post-waiting period, 1 week post-intervention, and 3-months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Community Functioning from Baseline to Post-Intervention, Relative to Change Observed During the 8-Week Wait-List Period (Role Functioning Scale)	The investigators will measure community functioning through the Role Functioning Scale. Each of the 4 items of the Role Functioning Scale is scored on a scale of 1 to 7. The total score is from 4 to 28 with a higher score indicating greater community functioning.	Participants complete the Role Functioning Scale at baseline, 1 week post-waiting period, 1 week post-intervention, and 3-months post-intervention.
Change from Baseline in Goal Attainment from Baseline to Post-Intervention, Relative to Change Observed During the 8-Week Wait-List Period (Goal Attainment Scaling)	The investigators will measure individualized goal achievement using Goal Attainment Scaling. Participants identify personal goals at baseline, and attainment of each goal is scored on a standardized scale ranging from -2 to +2, where higher scores indicate greater goal attainment.	Participants complete Goal Attainment Scaling at baseline, 1 week post-waiting period, 1 week post-intervention, and 3-months post-intervention.
Change from Baseline in Social and Occupational Functioning from Baseline to Post-Intervention, Relative to Change Observed During the 8-Week Wait-List Period (Social and Occupational Functioning Assessment Scale)	The investigators will measure social and occupational functioning using the Social and Occupational Functioning Assessment Scale (SOFAS). The SOFAS is scored on a scale from 0 to 100, with higher scores indicating better social and occupational functioning.	Participants complete the Social and Occupational Functioning Assessment Scale at baseline, 1 week post-waiting period, 1 week post-intervention, and 3-months post-intervention.
Feasibility of the intervention	The investigators will measure the feasibility of the intervention through a structured interview with participants using the RE-AIM dimensions and CFIR Hybrid Framework	Participants will conduct a structured interview 1 week-post intervention
Acceptability of the intervention	The investigators will measure the acceptability of the intervention through a structured interview with participants using the RE-AIM dimensions and CFIR Hybrid Framework	Participants will conduct a structured interview 1 week post-intervention
Change in Social Cognition from Baseline to Post-Intervention Relative to the 8-Week Wait-List Period (Brief Social Cognition and Emotional Processing)	Investigators will assess social cognition using the Brief Social Cognition and Emotional Processing assessment. The Brief Social Cognition and Emotional Processing includes tasks assessing emotional processing and social cognitive abilities. Scores are calculated based on participant performance on the assessment tasks, with higher scores indicating better social cognitive performance. Scores below 60 suggest impaired social cognition and functional impairment, whereas scores of 60 or above suggest intact social cognitive functioning.	Participants complete the BSCOPE at baseline, 1 week post-waiting period, 1 week post-intervention, and 3-months post-intervention.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Negative Symptom Severity from Baseline to Post-Intervention, Relative to Change Observed During the 8-Week Wait-List Period (Positive and Negative Severity Scale)	The investigators will measure symptom severity through the brief version of the brief version of the Positive and Negative Severity Scale (PANSS-6). Each of the 6 items of the PANSS-6 is rated on a scale of 7 points and the total score ranges from 6 to 42 with higher scores indicating more severe symptoms of a psychotic disorder.	Participants complete the brief version of the Positive and Negative Severity Scale at baseline, 1 week post-waiting period, 1 week post-intervention, and 3-months post-intervention.
Change from Baseline in Symptom Severity from Baseline to Post-Intervention, Relative to Change Observed During the 8-Week Wait-List Period (Hamilton Anxiety Rating Scale)	The investigators will measure anxiety symptom severity using the Hamilton Anxiety Rating Scale (HAM-A). The HAM-A consists of 14 items rated on a scale from 0 to 4. The total score ranges from 0 to 56, with higher scores indicating greater anxiety symptom severity.	Participants complete the Hamilton Anxiety Rating Scale at baseline, 1 week post-waiting period, 1 week post-intervention, and 3-months post-intervention.
Change from Baseline in Symptom Severity from Baseline to Post-Intervention, Relative to Change Observed During the 8-Week Wait-List Period (Patient Health Questionnaire-9)	The investigators will measure depressive symptom severity using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 consists of nine items rated on a scale from 0 to 3. The total score ranges from 0 to 27, with higher scores indicating greater depressive symptom severity.	Participants complete the Patient Health Questionnaire-9 at baseline, 1 week post-waiting period, 1 week post-intervention, and 3-months post-intervention.
Change from Baseline in Cognitive Motivation from Baseline to Post-Intervention, Relative to Change Observed During the 8-Week Wait-List Period (Cognitive Motivation Scale)	The investigators will measure cognitive motivation using the Cognitive Motivation Scale. The scale produces a total score representing the participant's level of motivation for cognitive engagement, with higher scores indicating greater cognitive motivation.	Participants complete the Cognitive Motivation Scale at baseline, 1 week post-waiting period, 1 week post-intervention, and 3-months post-intervention.
Change from Baseline in Self-Esteem from Baseline to Post-Intervention, Relative to Change Observed During the 8-Week Wait-List Period (Self-Esteem Rating Scale)	The investigators will measure self-esteem using the short form Self-Esteem Rating Scale. The scale produces a total score representing the participant's level of self-esteem, with higher scores indicating greater self-esteem.	Participants complete the Self-Esteem Rating Scale at baseline, 1 week post-waiting period, 1 week post-intervention, and 3-months post-intervention.

Collaborators and Investigators

• Sponsor: The Royal Ottawa Mental Health Centre

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2031

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cognitive Remediation Therapy; Social Cognition; Neurocognition; Cognitive Deficits; Transdiagnostic; Psychiatric Disorders; Cognitive Impairments; Action-Based Cognitive Remediation
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Neurocognitive Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Stress Disorders, Traumatic; Autism Spectrum Disorder; Bipolar and Related Disorders; Schizophrenia; Anxiety Disorders; Cognitive Dysfunction; Mood Disorders; Mental Disorders; Cognition Disorders; Combat Disorders
• Other Study ID Numbers: 2026375

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No