NCT05130853: SoCIAL

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

Completed NA Last updated 31 May 2023

What this trial tests

NA trial testing Social Skills and Neurocognitive Individualized Training (SoCIAL) in Schizophrenia in 48 participants. Completed in 31 July 2022.

Timeline

10 January 2021

Primary endpoint
31 July 2022

31 July 2022

Quick facts

Lead sponsor	University of Campania Luigi Vanvitelli
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	48
Start date	10 January 2021
Primary completion	31 July 2022
Estimated completion	31 July 2022
Sites	1 location across Italy

Drugs / interventions tested

• Social Skills and Neurocognitive Individualized Training (SoCIAL)
• Treatmment-as-usual

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →
• Schizo Affective Disorder — all drugs for Schizo Affective Disorder →

Sponsor

University of Campania Luigi Vanvitelli

Who can join

Adults 18 to 50, any sex, with Schizophrenia or Schizo Affective Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Social Cognition Individualized Activities Lab for Social Cognition Training and Narrative Enhancement in Patients With Schizophrenia: A Randomized Controlled Study to Assess Efficacy and Generalization to Real-Life Functioning (Prot. n°: NCT05130853).
   Palumbo D, Caporusso E, Piegari G, Mencacci C, et al · · 2022 · cited 6× · PMID 35444577 · DOI 10.3389/fpsyt.2022.833550
2. Effectiveness of a social cognition remediation intervention for patients with schizophrenia: a randomized-controlled study.
   Giuliani L, Pezzella P, Mucci A, Palumbo D, et al · · 2024 · cited 2× · PMID 39732701 · DOI 10.1186/s12991-024-00535-9