What side effects are associated with this type of intervention?

Cognitive remediation programs for schizophrenia, such as RC2S+, are generally well-tolerated and have fewer side effects compared to pharmacologic treatments. These programs aim to improve cognitive functions like memory, attention, and executive function. However, the most common treatments for schizophrenia also include antipsychotic medications, which can have side effects such as weight gain, metabolic syndrome, extrapyramidal symptoms (e.g., tremors, rigidity), and sedation. Second-generation antipsychotics are preferred due to their lower risk of extrapyramidal symptoms compared to first-generation antipsychotics.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of schizophrenia, including both first-generation antipsychotics like haloperidol and chlorpromazine, and second-generation antipsychotics such as risperidone, olanzapine, quetiapine, aripiprazole, and lurasidone. These medications primarily target psychotic symptoms but can also have some effects on cognitive functions. Cognitive remediation programs, like the RC2S+ being studied, aim to improve cognitive functions such as memory, attention, and executive function. While these programs are not FDA-approved treatments, they are often used in conjunction with pharmacological treatments to enhance overall outcomes in schizophrenia patients.

What other types of research exist?

Promising novel alternatives to RC2S+ for cognitive remediation in schizophrenia include: 1) Transcranial Direct Current Stimulation (tDCS), which has shown potential in enhancing neurocognition; 2) Cognitive Behavioral Therapy (CBT) tailored for cognitive deficits; 3) Computerized Cognitive Training programs that are increasingly being validated for their effectiveness; and 4) Pharmacological interventions such as acetylcholinesterase inhibitors (e.g., donepezil) that have shown some benefits in cognitive improvement.

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Cognitive Remediation

Cognitive Remediation Therapy for Schizophrenia (RC2S Trial)

N/A

Recruiting

Research Sponsored by Douglas Mental Health University Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

DSM-5 diagnosis of schizophrenia or a related psychotic disorder

Being 18 or older

Must not have

Inability to speak or read French or English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the administration time is estimated at 30 minutes.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if the RC2S+ program, which uses virtual reality to help people with schizophrenia improve their social skills, can be effectively used remotely. The study will involve adults with schizophrenia who struggle with social interactions. By practicing in a virtual environment, participants can learn and improve their social skills. The RC2S therapy is an individualized and partly computerized program through which patients practice social interactions and develop social cognitive abilities with simulation techniques in a realistic environment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves a non-medical treatment focusing on cognitive exercises delivered remotely, typical drug side effects are not expected. However, participants may experience fatigue or frustration during the tasks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot speak or read French or English.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the administration time is estimated at 30 minutes. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Combined Stories Test (COST)

Interpersonal, Personal and Situational Attributions Questionnaire (IPSAQ)

Penn Emotion Recognition Task (ER-40)

+1 more

Secondary study objectives

DACOBS: Davos Assessment of Cognitive Biases Scale

First-episode social functioning scale (FESF)

PANSS-6: Positive and Negative Syndrome Scale

+3 more

Other study objectives

Goal Attainment Scale (GAS)

MUSIC® Model of Motivation Inventory, Cognitive Training version (MMI-CT)

NIMH suicide screening questionnaire (NIMH-SSQ)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

Intervention with RC2S+ that consists of 24 biweekly sessions

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive remediation programs, such as RC2S+, aim to improve cognitive functions like memory, attention, and executive function through structured tasks and exercises designed to enhance neuroplasticity. This is particularly important for schizophrenia patients, as cognitive deficits are a core feature of the disorder and significantly impact daily functioning and quality of life. By targeting these cognitive impairments, cognitive remediation can help patients better manage their symptoms and improve their overall functioning, leading to a more independent and fulfilling life.

Cognitive impairment in schizophrenia.A critical review of research on psychosocial treatment of schizophrenia.Cognitive improvement in schizophrenia with novel antipsychotic medications.