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

ConditionsPsychiatric 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

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-60

SponsorThe Royal Ottawa Mental Health Centre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

160 Participants

are divided into 1 treatment group

Group A: Action-Based Cognitive Remediation (ABCR) with Waitlist Control PeriodExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

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.

Time frame

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)

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.

Time frame

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.

Time frame

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.

Time frame

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.

Other outcomes

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.

Time frame

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.

Time frame

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.

Time frame

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.

Time frame

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Royal Ottawa Mental Health Centre

Lead sponsor

Source ClinicalTrials.gov

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