Efficacy Study of a New Individualized Rehabilitation Programme for Social Cognition in Patients With Schizophrenia

Summary

Patients affected by schizophrenia often present significant deficits in various aspects of social cognition, such as social perception, recognition of one's own and other people's emotional state and the theory of mind. Recent studies investigated the correlation between social cognition and real-life functioning, reporting that greater social cognition deficits determine worse social and occupational functioning in real-life.

Therefore, social cognition deficits represent an important target both in therapeutic and rehabilitative treatment in patients with psychotic conditions, especially in the early phases of the disease.

Our research group has implemented a new individualized rehabilitation programme for social cognition: the Social Cognition Individualized Activities Lab, SoCIAL. The pivotal study showed that this programme improves specifically social cognition abilities, even when compared to a standardised and validated rehabilitation programme such as the Social Skills And Neurocognitive Individualized Training (SSANIT). However, the improvement in social cognition did not translate in improvement in real-life functioning.

Recently, another key aspect that plays a role in quality of life and real life functioning in people with schizophrenia has emerged, the narrative abilities. Available data confirm that this variable has a strong impact on social functioning and quality of life in patients with schizophrenia.

Taking into account the above evidence, our group decided to implement a new version of the social cognitive remediation programme in order to overcome the limitations found during its pivotal study. The new SoCIAL programme is characterized by specific modules for training of social cognition and narrative abilities in patients with schizophrenia. The efficacy of this programme, compared to treatment as usual, in individuals diagnosed with schizophrenia or schizoaffective disorder will be assessed. The generalization of improvement to real-life functioning domains will also be evaluated in completers and in the intent-to-treat sample.

Conditions

• Schizophrenia
• Schizo Affective Disorder

Interventions

BEHAVIORAL

Social Skills and Neurocognitive Individualized Training (SoCIAL)

SoCIAL is composed of two modules: 1. Social Cognition Training The Emotions recognition training will train the subject's ability in discriminating between different emotional states through photos and videos. The Theory of Mind (ToM) training will help subjects discriminate between emotional expressions in social contexts and understand other people's mental state with videos that display actors expressing several emotional states. More details in Palumbo et al., 2017. 2. Narrative Enhancement Training The narrative enhancement training consists in story-telling exercises focused on improving the subject's capacity to comprehend his/her emotional experience.

OTHER

Treatmment-as-usual

Subjects that will be randomized in this group will receive their treatment as usual for the whole length of the study. TAU includes all the psychiatric therapies (pharmacological, psychological, occupational etc) that subjects may have begun before study's enrollment.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli

  lead OTHER

Principal Investigators

• Mario Maj, MD, PhD · Department of Psychiatry - University of Campania "Luigi Vanvitelli"

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-10

Primary Completion

2022-07-31

Completion

2022-07-31

Countries

• Italy

Study Locations