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PsychosisRC2SNCT05017532

Cognitive Remediation for Social Cognition in Schizophrenia and Related Disorders

A study testing The program Remédiation Cognitive de la Cognition Sociale en Schizophrénie (RC2S+) in people with Psychosis and Schizophrenia, run by Douglas Mental Health University Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psychosis, Schizophrenia, Cognitive Impairment
What is being tested?
The program Remédiation Cognitive de la Cognition Sociale en Schizophrénie (RC2S+)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteCanada
Study dates
6 Jan 2022to 14 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Douglas Mental Health University Institute

    Montreal, Quebec, H4H 1R3

Other trials in Canada

About this study

Official title: Cognitive Remediation for Social Cognition in Schizophrenia and Related Disorders: Acceptability, Feasibility and Preliminary Effects of Remoted RC2S+ (RC2S+ Remote)

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

Read the detailed description

Schizophrenia and related psychotic disorders are associated with major functioning difficulties encompassing various areas of everyday life such as social interactions or school and work performance. Cognition, and more particularly social cognition, defined as the mental processes underlying social interactions, is considered as one of the best predictors of functioning in schizophrenia and related psychotic disorders. Social cognitive deficits thus represent a promising treatment target to promote functional recovery. Cognitive remediation (CR) is a behavioural intervention that can improve social cognitive deficits and clinical symptoms and moderate to large effect sizes have been reported. While there is great excitement that such interventions can also improve functioning, very few CR program for social cognition have used a personalized approach to tailor treatment to individual difficulties despite the benefit of personalizing CR treatment in schizophrenia. The program Remédiation Cognitive de la Cognition Sociale en Schizophrénie (RC2S+) is a personalized CR treatment targeting social cognition using virtual reality to emulate daily social interactions. Two case studies conducted in France with people with schizophrenia have demonstrated acceptability and feasibility of in-person RC2S+ while providing preliminary evidence for efficacy with the report of significant improvement of social cognitive and functional difficulties. While these preliminary results are encouraging, the program has never been used in Canada. Psychosocial intervention, and particularly those targeting social cognition, need to be culturally adapted. Thus, a preliminary study is necessary to assess if RC2S+ is culturally adapted to the social norms and rules of French and English-speaking Canadians. Further, this study needs to consider the actual context of the COVID-19 pandemic which has highlighted the important vulnerability of people with psychotic disorders and the need to adapt evidence-based interventions such as CR to increase access to mental healthcare services. Online interventions have rapidly developed in the last year in response to COVID-19 and these interventions address important factors that are known to limit access to psychiatric care in people with psychotic disorders. A remote version will however require an acceptability and feasibility assessment.

Our main objective is to assess the acceptability, feasibility, and preliminary effect of the remoted RC2S+. To reach this goal, we will, 1) Translate the RC2S+ program in English and adapt the program for French Canadians and 2) Determine the acceptability, the feasibility and the preliminary effect of the remoted RC2S+.

Twenty-six participants with a diagnosis of schizophrenia and related psychotic disorder aged 18 years or older and who present with at least one social cognitive impairment will be recruited. They will be initially assessed for social cognition as well as clinical outcomes (e.g. symptoms, recovery, functioning). Then, participants will receive 24 biweekly individual sessions of RC2S+ of 1 hour with a therapist. Intra-session questionnaires will be administered at different timepoints to the participants and the therapists to assess therapeutic alliance, motivation toward treatment as well as the satisfaction regarding treatment. At the end of treatment, participants will be reassessed with the similar measures as baseline.

This study will provide the first insight of the preliminary effect of RC2S+ administered remotely, in addition to providing French-Canadian and English version of this novel program. The results of the current study will provide relevant information to improve the program and its delivery for a future efficacy study.

Being tested
The program Remédiation Cognitive de la Cognition Sociale en Schizophrénie (RC2S+)
Medical subject headings
Psychotic Disorders, Schizophrenia, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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

Study groups in NCT05017532
Study groupRoleWhat they receive
InterventionExperimentalIntervention with RC2S+ that consists of 24 biweekly sessions
Receives: Behavioral: The program Remédiation Cognitive de la Cognition Sociale en Schizophrénie (RC2S+)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: The administration time is estimated at 30 minutes.

  2. 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.

    Measured: The administration time is estimated at 5 minutes.

  3. 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.

    Measured: The administration time is estimated at 10 minutes.

  4. 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.

    Measured: The administration time is estimated at 10 minutes.

Secondary outcomes (6)
  1. DACOBS: Davos Assessment of Cognitive Biases Scale

    This questionnaire assesses cognitive biases through 42 items rated on a Likert scale from 1 (strongly disagree) to 7 (strongly agree).

    Measured: The administration time is estimated at 10 minutes.

  2. PANSS-6: Positive and Negative Syndrome Scale

    Through a semi-structured interview, the positive and negative symptomatology of schizophrenia is explored. In this reduced scale, the following symptoms are assessed: delusions, conceptual disorganization, hallucinations, flattened affect, passive social withdrawal, and poverty of speech.

    Measured: The administration time is estimated at 20 minutes.

  3. Social Interaction Anxiety Scale (SIAS)

    The SIAS is a 20 items self-report questionnaire to assess social anxiety. This questionnaire provides a clinical picture of the cognitive, affective, and behavioral reactions to interactional situations.

    Measured: The administration time is estimated at 5 minutes.

  4. Patient Health Questionnaire (PHQ-9)

    this questionnaire assesses the principal diagnostic criteria of major depression.

    Measured: The administration time is estimated at 5 minutes.

  5. First-episode social functioning scale (FESF)

    This self-report questionnaire aims to assess functioning in several areas including productive activities (e.g. school, work), social functioning (e.g. family, friends, acquaintances) and instrumental activities of daily living (e.g. transportation, money management). Items are rated on a Likert scale ranging from "completely disagree" to "completely agree" for the ability of the participant to perform the activity, and on a scale ranging from "Never" to "Always" for the frequency of the activity (with the option never if the activity is not performed by the participant).

    Measured: The administration time is estimated at 10 minutes.

  6. The Questionnaire about the process of recovery (QPR)

    The QPR is a 22 item self- report measure measuring the process of recovery from a psychotic disorder. The items are rated on a five-point Likert scale ranging from "strongly disagree" to "strongly agree".

    Measured: The administration time is estimated at 5 minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2021
  2. Study start6 Jan 2022
  3. Primary completion14 Feb 2025
  4. Study completion14 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05017532
Sponsor's protocol ID
RC2S
Acronym
RC2S
Status last verified
Feb 2025
First submitted
17 Aug 2021
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38477975

Questions about this trial

What is this clinical trial studying?

A study testing The program Remédiation Cognitive de la Cognition Sociale en Schizophrénie (RC2S+) in people with Psychosis and Schizophrenia, run by Douglas Mental Health University Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined Stories Test (COST) (time frame: The administration time is estimated at 30 minutes.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05017532, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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