Cognitive Rehabilitation in Schizophrenia and Depression

Schizophrenia and depression are among the most disabling disorders in all of medicine. Cognitive deficits play a key role in patients' disability, affecting their capacity to contribute actively to society by sustaining employment or academic activity. Moreover, cognitive difficulties tend to persist even after the stabilization of other clinical symptoms. Verbal memory and emotion regulation are two important cognitive domains that are impaired in schizophrenia and depression and are associated with patients' functional outcomes. However, no medication has shown clear positive effects on these impairments at this point. Therefore, there is a great need to find effective cognitive remediation treatments (CRT) that could improve these domains in both psychiatric populations. In this study, the investigators will assess the efficacy of a cognitive rehabilitation intervention on the targetted cognitive domains (i.e., verbal memory and emotion regulation), general cognition, brain functioning, community functioning, symptom severity, and perceived cognitive deficits in both psychiatric populations. The study team also aims to investigate potential predictors of positive response to the intervention.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia / Schizoaffective Disorder; Depression / Major Depressive Disorder
• Intervention / Treatment: Behavioral: Cognitive Intervention; Behavioral: Active Control Intervention

Detailed Description

Participants will be randomized into either a treatment group or an active control group for 6 weeks. They will also be invited to undergo clinical and cognitive assessments as well as brain imaging before and after 6 weeks of intervention in order to compare the efficacy of the intervention. Additionally, their verbal memory and emotion regulation abilities will be assessed mid-intervention to examine the specific effect of each CRT module.

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Z 7K4
      • Recruiting
      • Royal Ottawa Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age 18-45 years
• current Intelligence Quotient (IQ) > 70 as measured by the Wechsler Abbreviated Scale of Intelligence (WASI)
• the ability to read and speak fluent English
• a diagnosis of schizophrenia, schizoaffective or major depression disorder
• stable medication for more than one month

Exclusion Criteria:

• significant neurological or other medical disorders that may produce cognitive impairment
• a recent history of substance abuse or dependence (within the past 3 months)
• any magnetic resonance imaging (MRI) contraindications (e.g. metallic head implant, history of seizure, pacemaker)
• decisional incapacity requiring a guardian
• taking medications that are rated as Anticholinergic Burden (ACB) Score 3 (severe) or taking benzodiazepines on a daily basis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Intervention	Behavioral: Cognitive Intervention; In each of the 6 visits, participants will be completing some computerized tasks for a period of about 40 minutes. At the end of each session, there will be 10-15 minutes of bridging discussion between the research therapist and the participants. (More details about each condition will be added after study completion to protect the blinding of our participants) .
Active Comparator: Active Control Intervention	Behavioral: Active Control Intervention; In each of the 6 visits, participants will be completing some computerized tasks for a period of about 40 minutes. At the end of each session, there will be 10-15 minutes of bridging discussion between the research therapist and the participants. (More details about each condition will be added after study completion to protect the blinding of our participants) .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in verbal memory performance from baseline - Hopkins Verbal Learning Test-Revised (HVLT-R)	The Hopkins Verbal Learning Test - Revisited (HVLT-R) for verbal memory is a 12-item test to measure a person's ability to encode, combine, store and recover verbal information in memory.	baseline, mid-treatment (3 weeks) and post treatment (7 weeks)
Change in emotion regulation performance from baseline - Mayer-Salovey-Caruso Emotional Intelligence Test (MSECIT)	The Mayer-Salovey- Caruso Emotional Intelligence Test (MSCEIT) is a 141-item ability-based test designed to measure the four branches of emotional intelligence model of Mayer and Salovey (including emotion regulation).	baseline, mid-treatment (3 weeks) and post treatment (7 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in composite scores on cognitive assessments from baseline	Assessed with a battery of standardized tests examining cognitive capacity. These tests measure various cognitive domains such as attention, memory, executive function, speed of processing and emotion recognition.	baseline and post treatment (7 weeks)
Change in brain activity from baseline	Brain activity as measured using resting-state and task-based functional magnetic resonance imaging (fMRI).	baseline and post treatment (8 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in composite scores on social functioning from baseline	Assessed with a battery of standardized tests examining social functioning. These tests measure an individual's level of social and occupational functioning as well as performance on everyday functional tasks (e.g., making phone calls, counting change, etc.).	baseline and post treatment (9 weeks)
Change in symptom severity from baseline - Positive and Negative Syndrome Scale (PANSS)	The Positive and Negative Syndrome Scale (PANSS) is a 30-item medical scale used for measuring symptom severity of patients with schizophrenia. Total scores range from 30 to 210, with a larger score indicating greater severity of symptoms.	baseline and post treatment (9 weeks)
Change in perceived cognitive impairments from baseline - Subjective Scale to Investigate Cognition in Schizophrenia - Brief (SSTICS-B)	The Subjective Scale to Investigate Cognition in Schizophrenia - Brief (SSTICS-B) is a self-rated 14-item scale that assesses the subjective level of cognitive abilities over the past week, ranging from "never" to "very often". The total score of SSTICS ranges from 0 to 84, with a greater score indicating greater perceived cognitive impairments.	baseline and post treatment (9 weeks)

Collaborators and Investigators

• Sponsor: The Royal Ottawa Mental Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2019
• Primary Completion (Anticipated): October 1, 2026
• Study Completion (Anticipated): October 1, 2026

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Depression; Depressive Disorder; Schizophrenia; Disease; Psychotic Disorders; Depressive Disorder, Major
• Other Study ID Numbers: 2018037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data collected from this study may be shared with other researchers at the Royal's Institute of Mental Health Research for analyses and re-analyses. Variables of the study and scripts used for analyses will be made available to the public. De-identified data will also be shared with the general public upon request. Data that can connect with participants' identity will NOT be used or shared for analyses.
• IPD Sharing Time Frame: De-identified data will become available upon completion of the study and once results have been published in an academic journal (anticipated time frame: the year of 2024).
• IPD Sharing Supporting Information Type: SAP; ANALYTIC_CODE

Drug and device information, study documents

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