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.
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+)
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Psychosis, Schizophrenia, Cognitive Impairment
- 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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention 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.
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.
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.
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.
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)
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.
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.
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.
Patient Health Questionnaire (PHQ-9)
this questionnaire assesses the principal diagnostic criteria of major depression.
Measured: The administration time is estimated at 5 minutes.
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.
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.
- First posted24 Aug 2021
- Study start6 Jan 2022
- Primary completion14 Feb 2025
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Douglas Mental Health University Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Lepage, McGill University
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation for Social Cognition in Schizophrenia and Related Disorders: Acceptability, Feasibility and Preliminary Effects of Remoted RC2S+ (RC2S+ Remote)
- ClinicalTrials.gov ID
- NCT05017532
- Acronym / sponsor ID
- RC2S / RC2S
- Conditions
- Psychosis, Schizophrenia, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Douglas Mental Health University InstituteUniversity, hospital or other
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate whether the remote administration of the cognitive remediation program RC2S+ acceptable and feasible in people with schizophrenia and related disorders.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: The program Remédiation Cognitive de la Cognition Sociale en Schizophrénie (RC2S+)Intervention with RC2S+ that consists of 24 biweekly sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The program Remédiation Cognitive de la Cognition Sociale en Schizophrénie (RC2S+)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 | Behavioural | Intervention |
Primary outcome
Combined Stories Test (COST)
Time frame: The administration time is estimated at 30 minutes.
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.
Social Knowledge Test (SKT)
Time frame: The administration time is estimated at 5 minutes.
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.
Penn Emotion Recognition Task (ER-40)
Time frame: The administration time is estimated at 10 minutes.
This test assesses emotion recognition on faces. A total of 40 faces are presented to the participants who must choose between five different emotions.
Interpersonal, Personal and Situational Attributions Questionnaire (IPSAQ)
Time frame: The administration time is estimated at 10 minutes.
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.
6 secondary outcomes
DACOBS: Davos Assessment of Cognitive Biases Scale
Time frame: The administration time is estimated at 10 minutes.
PANSS-6: Positive and Negative Syndrome Scale
Time frame: The administration time is estimated at 20 minutes.
Social Interaction Anxiety Scale (SIAS)
Time frame: The administration time is estimated at 5 minutes.
Patient Health Questionnaire (PHQ-9)
Time frame: The administration time is estimated at 5 minutes.
First-episode social functioning scale (FESF)
Time frame: The administration time is estimated at 10 minutes.
The Questionnaire about the process of recovery (QPR)
Time frame: The administration time is estimated at 5 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Derived from this study: PubMed 38477975Thibaudeau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.