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

NCT07506070 | Not Yet Recruiting

• 1 other identifier: 2026375
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Psychiatric Disorders; Depression - Major Depressive Disorder; Schizophrenia and Other Psychotic Disorders; Anxiety and Mood Disorders; Bipolar and Related Disorders; PTSD - Post Traumatic Stress Disorder; Autism Spectrum Disorder

Keywords

Transdiagnostic; Action-Based Cognitive Remediation; Cognitive Remediation Therapy; Psychiatric Disorders; Cognitive Impairments; Cognitive Deficits; Neurocognition; Social Cognition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Social Cognition from Baseline to Post-Intervention Relative to the 8-Week Wait-List Period (Brief Social Cognition and Emotional Processing)

  Participants complete the BSCOPE at baseline, 1 week post-waiting period, 1 week post-intervention, and 3-months post-intervention.

• 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)

  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)

  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)

  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

  Participants will conduct a structured interview 1 week-post intervention

Other Outcomes (5)

• 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)

  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)

  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)

  Participants complete the Patient Health Questionnaire-9 at baseline, 1 week post-waiting period, 1 week post-intervention, and 3-months post-intervention.

Study Arms (1)

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

EXPERIMENTAL

Behavioral: Action-Based Cognitive Remediation

Interventions

Action-Based Cognitive Remediation BEHAVIORAL

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.

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Royal Ottawa Mental Health Centre: lead

MeSH Terms

Conditions

Mental Disorders; Schizophrenia; Anxiety Disorders; Mood Disorders; Bipolar and Related Disorders; Combat Disorders; Autism Spectrum Disorder; Cognitive Dysfunction; Cognition Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Neurocognitive Disorders

Central Study Contacts

Yasmine Tiraoui-Elkhoumri, BA

CONTACT

613-722-6521; ytiraoui@theroyal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2031
• Last Updated: April 20, 2026

Record last verified: 2026-04