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Cognitive Rehabilitation in Schizophrenia and Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159662
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Synthia Guimond, The Royal Ottawa Mental Health Centre

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.

Condition or disease Intervention/treatment Phase
Schizophrenia / Schizoaffective Disorder Depression / Major Depressive Disorder Behavioral: Cognitive Intervention Behavioral: Active Control Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator, Outcomes 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.
Primary Purpose: Treatment
Official Title: Cognitive Rehabilitation in Schizophrenia and Depression
Actual Study Start Date : December 12, 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


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) .




Primary Outcome Measures :
  1. Change in verbal memory performance from baseline - Hopkins Verbal Learning Test-Revised (HVLT-R) [ Time Frame: baseline, mid-treatment (3 weeks) and post treatment (7 weeks) ]
    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.

  2. Change in emotion regulation performance from baseline - Mayer-Salovey-Caruso Emotional Intelligence Test (MSECIT) [ Time Frame: baseline, mid-treatment (3 weeks) and post treatment (7 weeks) ]
    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 :
  1. Change in composite scores on cognitive assessments from baseline [ Time Frame: baseline and post treatment (7 weeks) ]
    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.

  2. Change in brain activity from baseline [ Time Frame: baseline and post treatment (8 weeks) ]
    Brain activity as measured using resting-state and task-based functional magnetic resonance imaging (fMRI).


Other Outcome Measures:
  1. Change in composite scores on social functioning from baseline [ Time Frame: baseline and post treatment (9 weeks) ]
    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.).

  2. Change in symptom severity from baseline - Positive and Negative Syndrome Scale (PANSS) [ Time Frame: baseline and post treatment (9 weeks) ]
    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.

  3. Change in perceived cognitive impairments from baseline - Subjective Scale to Investigate Cognition in Schizophrenia - Brief (SSTICS-B) [ Time Frame: baseline and post treatment (9 weeks) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159662


Contacts
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Contact: Synthia Guimond, PhD 6137226521 ext 6586 Synthia.Guimond@theroyal.ca

Locations
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Canada, Ontario
Royal Ottawa Mental Health Center Recruiting
Ottawa, Ontario, Canada, K1Z 7K4
Contact: Synthia Guimond, PhD    6137226521 ext 6586    Synthia.Guimond@theroyal.ca   
Sponsors and Collaborators
The Royal Ottawa Mental Health Centre
Investigators
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Principal Investigator: Synthia Guimond, PhD Royal Ottawa Mental Health Centre
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Responsible Party: Synthia Guimond, Scientist, The Royal Ottawa Mental Health Centre
ClinicalTrials.gov Identifier: NCT04159662    
Other Study ID Numbers: 2018037
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Statistical Analysis Plan (SAP)
Analytic Code
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).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Depression
Depressive Disorder
Schizophrenia
Depressive Disorder, Major
Psychotic Disorders
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders