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Cognitive Remediation
RC2S+ for Schizophrenia(RC2S Trial)
Douglas Mental Health University Institute, Montréal, Canada
Targeting 3 different conditionsThe program Remédiation Cognitive de la Cognition Sociale en Schizophrénie (RC2S+)N/ARecruitingResearch Sponsored by Douglas Mental Health University InstituteEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Having an objective difficulty in social cognition (i.e. emotion recognition, theory of mind, attributional bias, social perception) defined as a performance equal of below 1 standard deviation from the normative group on one of the following measures: Penn Emotion Recognition Task (ER-40; Emotion recognition), Combined Stories Test (COST; Theory of mind), Social Knowledge test (SKT; Social knowledge) or Interpersonal, Personal and Situational Attributions Questionnaire (IPSAQ; Attributional style). This criterion is mandatory since we need to be able to remediate a difficulty during cognitive remediation.
DSM-5 diagnosis of schizophrenia or a related psychotic disorder
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upthe administration time is estimated at 30 minutes.
Awards & highlights
No Placebo-Only Group
RC2S Trial Summary
This trial will investigate whether a cognitive remediation program can be administered remotely to people with schizophrenia and related disorders.
Eligible Conditions
- Schizophrenia
- Cognitive Impairment
- Psychosis
RC2S Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have been diagnosed with schizophrenia or a similar disorder by a mental health professional.
RC2S Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the administration time is estimated at 30 minutes.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the administration time is estimated at 30 minutes.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Combined Stories Test (COST)
Interpersonal, Personal and Situational Attributions Questionnaire (IPSAQ)
Penn Emotion Recognition Task (ER-40)
+1 moreSecondary outcome measures
DACOBS: Davos Assessment of Cognitive Biases Scale
First-episode social functioning scale (FESF)
PANSS-6: Positive and Negative Syndrome Scale
+3 moreOther outcome measures
Goal Attainment Scale (GAS)
MUSIC® Model of Motivation Inventory, Cognitive Training version (MMI-CT)
NIMH suicide screening questionnaire (NIMH-SSQ)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
RC2S Trial Design
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Intervention with RC2S+ that consists of 24 biweekly sessions
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Who is running the clinical trial?
Douglas Mental Health University InstituteLead Sponsor
28 Previous Clinical Trials
2,620 Total Patients Enrolled
3 Trials studying Schizophrenia
573 Patients Enrolled for Schizophrenia
McGill UniversityLead Sponsor
382 Previous Clinical Trials
984,283 Total Patients Enrolled
2 Trials studying Schizophrenia
439 Patients Enrolled for Schizophrenia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are being followed and treated by a clinician of the Douglas Mental Health University Hospital.You have difficulty understanding emotions, social situations, and people's intentions, as shown by specific tests. This is important because we will be working to improve your social cognition skills during the trial.You are considered to be symptomatically stable and capable of using the online platforms, as judged by their primary clinicians (i.You have been diagnosed with schizophrenia or a similar mental disorder according to DSM-5.You have access to digital technology, Internet and access to a private space (a room where the participant can be alone).You have a medical condition or history of brain injury that can cause problems with thinking and memory.You have a history of intellectual disability or autism spectrum disorder.You have been diagnosed with schizophrenia or a similar disorder by a mental health professional.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigation currently recruiting participants?
"Clinicaltrials.gov indicates that this clinical trial is actively looking for volunteers, with the research campaign first being posted on June 1st 2022 and most recently revised on October 21st 2022."
Answered by AI
What do researchers hope to learn by conducting this trial?
"The principal aim of this trial is to assess the effectiveness of Penn Emotion Recognition Task (ER-40) over a predetermined period. In addition, Patient Health Questionnaire (PHQ-9), Davos Assessment of Cognitive Biases Scale (DACOBS), and Positive and Negative Syndrome Scale (PANSS-6) will be used as secondary measures for evaluation; each requiring approximately 5 minutes in administration. PHQ-9 evaluates major depression criteria, DACOBS gauges cognitive biases via Likert scale responses from 1 - 7, while PANSS-6 examines schizophrenic symptoms such as delusions, hallucinations, flat"
Answered by AI
How many individuals are engaged in this clinical research?
"Affirmative. Clinicaltrials.gov supports the assertion that this clinical trial is actively recruiting participants, beginning on January 6th 2022 and with its most recent update occurring on October 21st of the same year. The study seeks to recruit 26 individuals from a single medical centre."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
What site did they apply to?
Douglas Mental Health University Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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