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Cognitive Rehabilitation in Schizophrenia and Depression

Primary Purpose

Schizophrenia / Schizoaffective Disorder, Depression / Major Depressive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Intervention
Active Control Intervention
Sponsored by
The Royal Ottawa Mental Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia / Schizoaffective Disorder

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Ottawa Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Intervention

Active Control Intervention

Arm Description

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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.
Change in brain activity from baseline
Brain activity as measured using resting-state and task-based functional magnetic resonance imaging (fMRI).

Full Information

First Posted
October 25, 2019
Last Updated
April 12, 2023
Sponsor
The Royal Ottawa Mental Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT04159662
Brief Title
Cognitive Rehabilitation in Schizophrenia and Depression
Official Title
Cognitive Rehabilitation in Schizophrenia and Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2019 (Actual)
Primary Completion Date
October 1, 2026 (Anticipated)
Study Completion Date
October 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Royal Ottawa Mental Health Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia / Schizoaffective Disorder, Depression / Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Masking Description
Due to the nature of the intervention, treatment administrators will not be able to remain blind to group assignment; however, assessment staff, investigators, and participants will be blind to group assignment. Assessment staff and investigators will never be involved in the randomization or treatment procedures.
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Intervention
Arm Type
Experimental
Arm Title
Active Control Intervention
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Intervention
Intervention Description
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) .
Intervention Type
Behavioral
Intervention Name(s)
Active Control Intervention
Intervention Description
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) .
Primary Outcome Measure Information:
Title
Change in verbal memory performance from baseline - Hopkins Verbal Learning Test-Revised (HVLT-R)
Description
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.
Time Frame
baseline, mid-treatment (3 weeks) and post treatment (7 weeks)
Title
Change in emotion regulation performance from baseline - Mayer-Salovey-Caruso Emotional Intelligence Test (MSECIT)
Description
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).
Time Frame
baseline, mid-treatment (3 weeks) and post treatment (7 weeks)
Secondary Outcome Measure Information:
Title
Change in composite scores on cognitive assessments from baseline
Description
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.
Time Frame
baseline and post treatment (7 weeks)
Title
Change in brain activity from baseline
Description
Brain activity as measured using resting-state and task-based functional magnetic resonance imaging (fMRI).
Time Frame
baseline and post treatment (8 weeks)
Other Pre-specified Outcome Measures:
Title
Change in composite scores on social functioning from baseline
Description
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.).
Time Frame
baseline and post treatment (9 weeks)
Title
Change in symptom severity from baseline - Positive and Negative Syndrome Scale (PANSS)
Description
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.
Time Frame
baseline and post treatment (9 weeks)
Title
Change in perceived cognitive impairments from baseline - Subjective Scale to Investigate Cognition in Schizophrenia - Brief (SSTICS-B)
Description
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.
Time Frame
baseline and post treatment (9 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Synthia Guimond, PhD
Phone
6137226521
Ext
6586
Email
Synthia.Guimond@theroyal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Synthia Guimond, PhD
Organizational Affiliation
Royal Ottawa Mental Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Ottawa Mental Health Center
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Z 7K4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Synthia Guimond, PhD
Phone
6137226521
Ext
6586
Email
Synthia.Guimond@theroyal.ca

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

Learn more about this trial

Cognitive Rehabilitation in Schizophrenia and Depression

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