Cognitive Rehabilitation in Schizophrenia and Depression

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cognitive Rehabilitation in Schizophrenia and Depression

Conditions
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Schizophrenia / Schizoaffective Disorder, Depression / Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Cognitive Intervention
* Behavioral: Active Control Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized to either 6 weeks of cognitive intervention (half of those will start with the verbal memory module, and the other half with the emotion regulation module) or 6 weeks of active control intervention.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Intervention<br> | Behavioral: Cognitive Intervention<br>* 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) .<br>|
| Active Comparator: Active Control Intervention<br> | Behavioral: Active Control Intervention<br>* 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) .<br>|

What is the study measuring?
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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) |