SchizophreniaRC2S+NCT02976077
RC2S+: Remediation of Social Cognitive Impairments
A study testing RC2S+ and active comparator in people with Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
Trial summary
Background: Difficulties in social interactions are a central characteristic of people with schizophrenia, and can be partly explained by impairments of social cognitive processes. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- RC2S+ and active comparator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2016to 30 Dec 2021
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-45 years old
- Diagnosis of schizophrenia assessed with DSM5 criteria (APA, 2013)
- No modification of psychotropic treatment during the month before inclusion (variation of 20% of the dose is tolerated
- French native language or education in a French school since the first year of primary school
- Consent to participate to the study and agreement of the legal guardian
- Patients who have not benefited from cognitive remediation during the three months before inclusion
Who cannot join
- Substance use disorder (criteria of DSM-5), except for caffeine and tobacco
- Neurologic disorders (vascular, infectious or neurodegenerative)
- Uncorrected visual deficit
- Medical drugs with cerebral or psychological effect (e.g, corticosteroids)
- Patients resistant to antipsychotic medication
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Validation of the RC2S+ Therapy in Schizophrenia
Background:
Difficulties in social interactions are a central characteristic of people with schizophrenia, and can be partly explained by impairments of social cognitive processes. According to renown researchers, three to five social cognitive processes are usually altered in schizophrenia: (1) emotional processing; (2) theory of mind (ToM); (3) attributional style; and (4 and 5) social perception and knowledge. The components of social cognition appear to be related to both symptomatology and functioning in everyday life.
Read more
New strategies of cognitive remediation have been recently developed to target these deficits and few meta analyses have assessed the extent to which social cognitive remediation programs have led to multiple improvements for schizophrenia patients. Overall, it seems that such therapies showed encouraging results in both patient interest and motivation, and social cognitive processes.
The RC2S therapy is the first individualized and partly computerized program through which patients practice social interactions and develop social cognitive abilities with simulation techniques in a realistic environment.
Read the detailed description
Methods:
This is a randomized controlled trial to establish the validity of the RC2S+ program in schizophrenia.
The project's main objective is to assess the impact of RC2S+ on social cognitive impairments in schizophrenia compared with a cognitive remediation program (control therapy) focusing on neurocognition, equivalent in terms of number, duration and rhythm of sessions.
The study has four other objectives:
- To assess the influence of the RC2S+ therapy versus control therapy on neurocognitive processes
- To assess the impact of the RC2S+ therapy versus control therapy on social functioning
- To assess the impact of the RC2S+ therapy versus control therapy on both positive and negative symptoms
- To study the maintenance of benefits 3 months forward
Outcomes:
To treat social cognitive impairments in people with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- RC2S+, active comparator
- Keywords
- social cognition, cognitive remediation, emotions, theory of mind, attributions, social perception
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC2S+Behavioural
new cognitive remediation program
active comparatorBehavioural
cognitive remediation program
| Study group | Role | What they receive |
|---|---|---|
| RC2S+ | Experimental | RC2S+
Preparation sessions (sessions 1 \& 2):
* Functional Outcomes Scale - Social Cognition (ERF-CS)
* Psychoeducation about social cognitive impairments
* Concrete objectives
Cognitive remediation (sessions 3 to 22):
* Paper-and-pencil session
* Simulation session
* Home-based task
Transfer sessions (sessions 23 \& 24):
* Transfer of skills in dayly life - generalization
* Assessment of the achievement of objectives Receives: Behavioral: RC2S+ |
| Control therapy | Active comparator | Control therapy
Preparation sessions (sessions 1 \& 2):
* Functional Outcomes Scale - Neurocognition
* Psychoeducation about cognitive impairments
* Concrete objectives
Cognitive remediation (sessions 3 to 24):
* Paper-and-pencil session
* Simulation session
* Home-based task Receives: Behavioral: active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the HB (Hostility Bias) score
AIHQ (Ambiguous Intentions Hostility Questionnaire)
Measured: week 12
Secondary outcomes (7)
Change from baseline in social cognitive
ACSO ( Self-Assessment Scale of Social Cognition Disorders)
Measured: week 12
Change from baseline in episodic verbal learning and memory
CVLT( California Verbal Learning Test),
Measured: week 12
Change from baseline in visual attention and task switching
TMT( Trial Making Test)
Measured: week 12
Change from baseline in social functioning
FEFSF (First Episode Social Functioning Scale)
Measured: week 12
Change from baseline in symptoms at week 12
PANSS (Positive And Negative Symptoms Scale)
Measured: week 12
Change from baseline in visuospatial abilities at week 12
TMT( Trial making Test)
Measured: week 12
Change from baseline in executive functioning at week 12
FNART(French National Adult reading Test)
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start29 Nov 2016
- Primary completion30 Jun 2021
- Study completion30 Dec 2021
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 SchizophreniaStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FRANCK NICOLAS, PUPH, Principal investigator, LE VINATIER HOSPITAL BRON FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976077
- Sponsor's protocol ID
- 2016-A01271-50
- Acronym
- RC2S+
- Status last verified
- Aug 2022
- First submitted
- 16 Nov 2016
- Last updated
- 12 Aug 2022
- Results posted
- No
Publications
Peyroux E, Prost Z, Amado I, Graux J, Demily C, Plasse J, Franck N; RC2S Consortium. Is the Cognitive Remediation of Social Cognition (RC2S) program useful to improve social cognition and functional outcomes in people with schizophrenia? A randomized controlled trial. Psychiatr Rehabil J. 2026 Jun;49(2):153-164. doi: 10.1037/prj0000673. Epub 2026 Jan 12.
PubMed 41525374
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Validation of the RC2S+ Therapy in Schizophrenia
- ClinicalTrials.gov ID
- NCT02976077
- Acronym / sponsor ID
- RC2S+ / 2016-A01271-50
- Conditions
- Schizophrenia
- Keywords
- social cognition, cognitive remediation, emotions, theory of mind, attributions, social perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 29 Nov 2016 (estimated)
- 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.
Background:
Difficulties in social interactions are a central characteristic of people with schizophrenia, and can be partly explained by impairments of social cognitive processes. According to renown researchers, three to five social cognitive processes are usually altered in schizophrenia: (1) emotional processing; (2) theory of mind (ToM); (3) attributional style; and (4 and 5) social perception and knowledge. The components of social cognition appear to be related to both symptomatology and functioning in everyday life.
New strategies of cognitive remediation have been recently developed to target these deficits and few meta analyses have assessed the extent to which social cognitive remediation programs have led to multiple improvements for schizophrenia patients. Overall, it seems that such therapies showed encouraging results in both patient interest and motivation, and social cognitive processes.
The RC2S therapy is the first individualized and partly computerized program through which patients practice social interactions and develop social cognitive abilities with simulation techniques in a realistic environment.
Detailed description
Methods:
This is a randomized controlled trial to establish the validity of the RC2S+ program in schizophrenia.
The project's main objective is to assess the impact of RC2S+ on social cognitive impairments in schizophrenia compared with a cognitive remediation program (control therapy) focusing on neurocognition, equivalent in terms of number, duration and rhythm of sessions.
The study has four other objectives:
- To assess the influence of the RC2S+ therapy versus control therapy on neurocognitive processes
- To assess the impact of the RC2S+ therapy versus control therapy on social functioning
- To assess the impact of the RC2S+ therapy versus control therapy on both positive and negative symptoms
- To study the maintenance of benefits 3 months forward
Outcomes:
To treat social cognitive impairments in people with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RC2S+ | Experimental | Behavioral: RC2S+RC2S+ Preparation sessions (sessions 1 \& 2): * Functional Outcomes Scale - Social Cognition (ERF-CS) * Psychoeducation about social cognitive impairments * Concrete objectives Cognitive remediation (sessions 3 to 22): * Paper-and-pencil session * Simulation session * Home-based task Transfer sessions (sessions 23 \& 24): * Transfer of skills in dayly life - generalization * Assessment of the achievement of objectives |
| Control therapy | Active comparator | Behavioral: active comparatorControl therapy Preparation sessions (sessions 1 \& 2): * Functional Outcomes Scale - Neurocognition * Psychoeducation about cognitive impairments * Concrete objectives Cognitive remediation (sessions 3 to 24): * Paper-and-pencil session * Simulation session * Home-based task |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged 18-45 years old
- Diagnosis of schizophrenia assessed with DSM5 criteria (APA, 2013)
- No modification of psychotropic treatment during the month before inclusion (variation of 20% of the dose is tolerated
- French native language or education in a French school since the first year of primary school
- Consent to participate to the study and agreement of the legal guardian
Key exclusion criteria (6 listed)
- Substance use disorder (criteria of DSM-5), except for caffeine and tobacco
- Neurologic disorders (vascular, infectious or neurodegenerative)
- Uncorrected visual deficit
- Medical drugs with cerebral or psychological effect (e.g, corticosteroids)
- Patients resistant to antipsychotic medication
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 |
|---|---|---|
| RC2S+new cognitive remediation program | Behavioural | RC2S+ |
| active comparatorcognitive remediation program | Behavioural | Control therapy |
Primary outcome
Change from baseline in the HB (Hostility Bias) score
Time frame: week 12
AIHQ (Ambiguous Intentions Hostility Questionnaire)
7 secondary outcomes
Change from baseline in social cognitive
Time frame: week 12
Change from baseline in episodic verbal learning and memory
Time frame: week 12
Change from baseline in visual attention and task switching
Time frame: week 12
Change from baseline in social functioning
Time frame: week 12
Change from baseline in symptoms at week 12
Time frame: week 12
Change from baseline in visuospatial abilities at week 12
Time frame: week 12
Change from baseline in executive functioning at week 12
Time frame: week 12
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 12 Aug 2022.
- Derived from this study: PubMed 41525374Peyroux E, Prost Z, Amado I, Graux J, Demily C, Plasse J, Franck N; RC2S Consortium. Is the Cognitive Remediation of Social Cognition (RC2S) program useful to improve social cognition and functional outcomes in people with schizophrenia? A randomized controlled trial. Psychiatr Rehabil J. 2026 Jun;49(2):153-164. doi: 10.1037/prj0000673. Epub 2026 Jan 12.
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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.
FRANCK NICOLAS, PUPH principal investigator
LE VINATIER HOSPITAL BRON FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RC2S+ and active comparator in people with Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
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 6 inclusion and 6 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 12 Aug 2022. 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 France. 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?
Change from baseline in the HB (Hostility Bias) score (time frame: week 12). 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 NCT02976077, 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 12 Aug 2022.