Cognitive Remediation Therapy for Schizophrenia

(RC2S Trial)

Not currently recruiting at 1 trial location

Overseen By Karyne Anselmo, M.Sc.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Douglas Mental Health University Institute

Disqualifiers: Neurological disease, Brain trauma, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a cognitive therapy program called RC2S+ (Remédiation Cognitive de la Cognition Sociale en Schizophrénie) to determine its effectiveness and ease of use for individuals with schizophrenia and related disorders. Participants will engage in 24 online sessions to enhance social skills, such as recognizing emotions and understanding others' perspectives. The trial seeks individuals diagnosed with schizophrenia or a similar disorder who experience difficulties with social interactions and have internet access. Participants should not have other neurological issues or be currently hospitalized. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve social skills therapy for schizophrenia.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the RC2S+ program is safe for people with schizophrenia?

Research has shown that the RC2S+ program, a therapy designed to enhance thinking skills in people with schizophrenia, is generally well-tolerated. In past studies, similar programs improved social skills without major side effects.

Although detailed information on negative reactions to RC2S+ is limited, therapies of this kind are usually safe because they involve mental exercises rather than medications. This typically means they don't cause the physical side effects that drugs might.

For those considering joining a trial for RC2S+, research so far suggests it is a safe method to address social challenges related to schizophrenia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

RC2S+ is unique because it focuses specifically on cognitive remediation for social cognition in schizophrenia. Unlike traditional antipsychotic medications that primarily target symptoms like hallucinations and delusions, RC2S+ aims to improve social interaction and cognitive function through 24 biweekly sessions. Researchers are excited about this approach as it addresses a crucial aspect of daily functioning in schizophrenia, potentially enhancing the quality of life and social integration for patients.

What evidence suggests that the RC2S+ program is effective for schizophrenia?

Research has shown that programs like RC2S+, which participants in this trial will receive, can help people with schizophrenia. These programs focus on improving social cognition, which involves understanding and interacting with others. Studies have found that these treatments can enhance cognitive abilities, such as memory and attention. This improvement is important because better cognitive skills can enhance daily life and job performance. Early findings suggest that participants in these programs often notice positive changes in their social interactions and thinking skills. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults with schizophrenia or related psychotic disorders who are stable and treated at the Douglas Mental Health University Hospital. They must have trouble with social cognition, access to digital technology and a private space, and be able to nominate an emergency contact. People can't join if they're hospitalized, don't speak French or English, have cognitive issues due to organic causes like brain trauma, or have mental retardation or autism.

Inclusion Criteria

Having access to digital technology, Internet, and a private space

I have been diagnosed with schizophrenia or a similar mental health condition.

Having an objective difficulty in social cognition defined as a performance equal of below 1 standard deviation from the normative group on specific measures

Exclusion Criteria

I cannot speak or read French or English.

History of mental retardation or autism spectrum disorder

Being hospitalized at the time of recruitment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 24 biweekly individual sessions of RC2S+ with a therapist

12 weeks

24 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Remédiation Cognitive de la Cognition Sociale en Schizophrénie (RC2S+)

Trial Overview The study tests the RC2S+ program's remote delivery for improving social cognition in people with schizophrenia-related conditions. It aims to see if this online cognitive remediation approach is practical and acceptable for participants.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Intervention with RC2S+ that consists of 24 biweekly sessions

Who Is Running the Clinical Trial?

Douglas Mental Health University Institute

Lead Sponsor

Trials

31

Recruited

2,800+

McGill University

Lead Sponsor

Trials

421

Recruited

1,017,000+

Citations

1. researchgate.net researchgate.net/publication/371461969_Remediation_de_la_cognition_sociale_dans_la_schizophrenie_RC2S

Remédiation de la cognition sociale dans la schizophrénie ... Cognitive remediation for schizophrenia, which is intended to improve both cognition and functional outcome, has been shown to impact cognition regardless ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4055942/

RC2S: A Cognitive Remediation Program to Improve Social ... The best outcomes in the area of social cognition in schizophrenia are those obtained by way of cognitive remediation programs. New strategies ...

3. sciencedirect.com sciencedirect.com/org/science/article/pii/S1929074824001082

Navigating Social Cognitive Impairments in Schizophrenia ... Social cognitive impairments are prevalent in schizophrenia spectrum disorder (SSD) and have detrimental effects on functioning.

4. esmed.org esmed.org/MRA/mra/article/view/544/338

Cognitive remediation and work outcomes in schizophrenia Abstract. Getting and keeping a job are some of the main criteria for recovery in schizophrenia, and are often undermined by cognitive impairments.

5. researchgate.net researchgate.net/publication/301620397_Improving_Social_Cognition_in_People_with_Schizophrenia_with_RC2S_Two_Single-Case_Studies

Improving Social Cognition in People with Schizophrenia ... Background Cognitive remediation (CR) is an effective therapy for the cognitive impact of mental illness, especially schizophrenia. Global ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10973955/

Navigating Social Cognitive Impairments in Schizophrenia ... ... psychosis, cognitive ... Best practices: the development of the social cognition and interaction training program for schizophrenia spectrum disorders.

7. researchgate.net researchgate.net/publication/377291382_Navigating_Social_Cognitive_Impairments_in_Schizophrenia_Spectrum_Disorders_Protocol_for_a_Pilot_Pre-Post_Quasi-Experimental_Study_for_Remote_Avatar-Assisted_Cognitive_Remediation_Therapy_Preprint

Navigating Social Cognitive Impairments in Schizophrenia ... Deficits in social cognition in first episode psychosis ... Conclusions SCT benefits people with schizophrenia on a variety of social‐cognitive outcomes.

8. researchgate.net researchgate.net/publication/389429572_Efficacy_of_integrated_social_cognitive_remediation_vs_neurocognitive_remediation_in_schizophrenia_Results_from_the_multicenter_randomized_controlled_ISST_Integrated_Social_Cognition_And_Social_Skills

(PDF) Efficacy of integrated social cognitive remediation vs ... Efficacy of integrated social cognitive remediation vs neurocognitive remediation in schizophrenia: Results from the multicenter randomized ...

9. escholarship.mcgill.ca escholarship.mcgill.ca/concern/articles/g445cm25b

Navigating Social Cognitive Impairments in Schizophrenia ... Background: Social cognitive impairments are prevalent in schizophrenia spectrum disorder (SSD) and have detrimental effects on functioning.

10. semanticscholar.org semanticscholar.org/paper/RC2S%3A-A-Cognitive-Remediation-Program-to-Improve-in-Peyroux-Franck/934b946630df6a4e97809ccca0532b41361bceb7

RC2S: A Cognitive Remediation Program to Improve ... The RC2S program seems to be a new useful program for social cognitive remediation in schizophrenia, based on the results of two case-studies involving two ...