Clinical trial NCT02976077: RC2S+: Remediation of Social Cognitive Impairments
Official title: Preliminary Validation of the RC2S+ Therapy in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: social cognition
cognitive remediation
emotions
theory of mind
attributions
social perception
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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:

1. To assess the influence of the RC2S+ therapy versus control therapy on neurocognitive processes
2. To assess the impact of the RC2S+ therapy versus control therapy on social functioning
3. To assess the impact of the RC2S+ therapy versus control therapy on both positive and negative symptoms
4. To study the maintenance of benefits 3 months forward

Outcomes:

To treat social cognitive impairments in people with schizophrenia.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline in the HB (Hostility Bias) score
timeFrame: week 12
Secondary outcomes:
measure: Change from baseline in social cognitive
timeFrame: week 12
measure: Change from baseline in episodic verbal learning and memory
timeFrame: week 12
measure: Change from baseline in visual attention and task switching
timeFrame: week 12
measure: Change from baseline in social functioning
timeFrame: week 12
measure: Change from baseline in symptoms at week 12
timeFrame: week 12
measure: Change from baseline in visuospatial abilities at week 12
timeFrame: week 12
measure: Change from baseline in executive functioning at week 12
timeFrame: week 12
Other outcomes:
Locations:
city: Lyon
country: France
facility: centre de réhabilitation - Hôpital le Vinatier
state: Rhône
Study officials:
affiliation: LE VINATIER HOSPITAL BRON FRANCE
name: FRANCK NICOLAS, PUPH
role: PRINCIPAL_INVESTIGATOR
References: