Cognitive Remediation for Social Cognition in Schizophrenia and Related Disorders

NCT05017532 | Active Not Recruiting

• 1 other identifier: RC2S
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate whether the remote administration of the cognitive remediation program RC2S+ acceptable and feasible in people with schizophrenia and related disorders.

Conditions

Psychosis; Schizophrenia; Cognitive Impairment

Outcome Measures

Primary Outcomes (4)

• Combined Stories Test (COST)

  This test assesses Theory of Mind (ToM) abilities and includes 30 short verbal stories. Participants are asked to read each story out loud and are asked to answer ToM and control questions.

  The administration time is estimated at 30 minutes.

• Social Knowledge Test (SKT)

  This test assesses social knowledge. Participants are presented with a series of short hypothetical situations and are asked to state how they think most people in this situation would feel.

  The administration time is estimated at 5 minutes.

• Penn Emotion Recognition Task (ER-40)

  This test assesses emotion recognition on faces. A total of 40 faces are presented to the participants who must choose between five different emotions.

  The administration time is estimated at 10 minutes.

• Interpersonal, Personal and Situational Attributions Questionnaire (IPSAQ)

  This test assesses attributional style. Participants are presented with 32 social situations and for each of them, they must decide what was the main cause of the event described in each statement and select if the cause is whether because of them, because of another person or because of the situation.

  The administration time is estimated at 10 minutes.

Secondary Outcomes (6)

• DACOBS: Davos Assessment of Cognitive Biases Scale

  The administration time is estimated at 10 minutes.

• PANSS-6: Positive and Negative Syndrome Scale

  The administration time is estimated at 20 minutes.

• Social Interaction Anxiety Scale (SIAS)

  The administration time is estimated at 5 minutes.

• Patient Health Questionnaire (PHQ-9)

  The administration time is estimated at 5 minutes.

• First-episode social functioning scale (FESF)

  The administration time is estimated at 10 minutes.

Other Outcomes (7)

• NIMH suicide screening questionnaire (NIMH-SSQ)

  The administration time is estimated at 5 minutes.

• Échelle de repercussions fonctionnelles des troubles de la cognition sociale (ERF-CS)

  The administration time is estimated at 10 minutes.

• Goal Attainment Scale (GAS)

  The administration time is estimated at 5 minutes.

Study Arms (1)

Intervention

EXPERIMENTAL

Intervention with RC2S+ that consists of 24 biweekly sessions

Behavioral: The program Remédiation Cognitive de la Cognition Sociale en Schizophrénie (RC2S+)

Interventions

The program Remédiation Cognitive de la Cognition Sociale en Schizophrénie (RC2S+) BEHAVIORAL

The program Remédiation Cognitive de la Cognition Sociale en Schizophrénie (RC2S+) is a personalized CR treatment targeting social cognition (e.g. theory of mind, emotion recognition) using virtual reality to emulate daily social interactions

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-5 diagnosis of schizophrenia or a related psychotic disorder
• Being followed and treated by a clinician of the Douglas Mental Health University Hospital
• Being 18 or older
• 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.
• Being considered symptomatically stable and capable of using the online platforms, as judged by their primary clinicians (i.e., psychiatrist, case manager, psychologist)
• Having access to digital technology, Internet and access to a private space (a room where the participant can be alone)
• Being able to nominate an emergency contact

You may not qualify if:

• Evidence of an organic cause for cognitive difficulties (e.g. neurological disease, history of brain trauma)
• History of mental retardation or autism spectrum disorder
• Being hospitalized at the time of recruitment
• Inability to speak or read French or English

Sponsors & Collaborators

• Douglas Mental Health University Institute: lead

Study Sites (1)

Douglas Mental Health University Institute

Montreal, Quebec, H4H 1R3, Canada

Location

Related Publications (1)

• Thibaudeau E, Peyroux E, Franck N, Carling H, Lepage M. Navigating Social Cognitive Impairments in Schizophrenia Spectrum Disorders: Protocol for a Pilot Pre-Post Quasi-Experimental Study for Remote Avatar-Assisted Cognitive Remediation Therapy. JMIR Res Protoc. 2024 Mar 13;13:e54251. doi: 10.2196/54251.

  PMID: 38477975 DERIVED

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 24, 2021
• Study Start: January 6, 2022
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)