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

NCT05130853 | Completed DMC

• 1 other identifier: 4870/2020
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cognitive remediation; psychiatric rehabilitation; social cognition

Outcome Measures

Primary Outcomes (9)

• Positive Symptoms

  The Positive and Negative Syndrome Scale (PANSS, administration time = 30') will be used for the evaluation of positive symptoms. The PANSS is a semistructured interview composed of 30 items divided in three subscales, namely positive symptoms, negative symptoms, and general psychopathology. Each item is accompanied by a specific definition and by detailed anchoring criteria for each rating point, ranging from "absent" (1) to "severe" (7). According to the five-factor model proposed by Wallwork et al. (2012), the investigators will calculate the positive dimension by summing the scores on the items "Delusions" (P1), "Hallucinatory behavior" (P3), "Grandiosity" (P5) and "Unusual thought content (G9).

  Pre (T0) and Post (T1) Intervention - 3 Months time frame

• Negative Symptoms

  The Positive and Negative Syndrome Scale (PANSS, administration time = 30') will be used for the evaluation of positive symptoms. The PANSS is a semistructured interview composed of 30 items divided in three subscales, namely positive symptoms, negative symptoms, and general psychopathology. Each item is accompanied by a specific definition and by detailed anchoring criteria for each rating point, ranging from "absent" (1) to "severe" (7). According to the five-factor model proposed by Wallwork et al. (2012), the investigators will calculate the negative dimension by summing the scores on the items "Blunted Affect" (N1), "Emotional Withdrawal" (N2), "Poor Rapport" (N3), "Passive/Apathetic Social Withdrawal" (N4) and "Lack of spontaneity" (N6).

  Pre (T0) and Post (T1) Intervention - 3 Months time frame

• Disorganization

  The Positive and Negative Syndrome Scale (PANSS, administration time = 30') will be used for the evaluation of the disorganized symptoms. The PANSS is a semistructured interview composed of 30 items divided in three subscales, namely positive symptoms, negative symptoms, and general psychopathology. Each item is accompanied by a specific definition and by detailed anchoring criteria for each rating point, ranging from "absent" (1) to "severe" (7). According to the five-factor model proposed by Wallwork et al. (2012), the disorganization dimension will be calculated with three PANSS items: "Conceptual disorganization" (P2), "Difficulty in abstract thinking" (N5), and "Poor attention" (G11).

  Pre (T0) and Post (T1) Intervention - 3 Months time frame

• Neurocognitive functions

  Neurocognitive functions will be assessed using the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB). This test includes items designed to evaluate six neurocognitive domains: a) processing speed; b) attention and vigilance; c) working memory; d) verbal learning and memory; e) visual learning and memory; f) reasoning and problem solving (administration time = 80'). 9 tests are included to measure neurocognitive domains (Category Fluency - Animal Naming; Brief Assessment of Cognition in Schizophrenia Symbol Coding; Trail Making Test - Part A; Continuous Performance Test - Identical Pairs; Wechsler Memory Scale Spatial Span; Letter-Number Span; Hopkins Verbal Learning Test - Revised; Brief Visuospatial Memory Test - Revised; Neuropsychological Assessment Battery - Mazes).

  Pre (T0) and Post (T1) Intervention - 3 Months time frame

• Social cognition

  Social cognition will be evaluated with the Mayer-Salovey-Caruso Emotional Intelligence Test included in the MCCB battery. To better assess social cognition (in addition to the MSCEIT) participants will undergo the Facial Emotional Identification Test (FEIT, administration time = 15') as well as the The Awareness of Social Inference Test (TASIT, evaluation time = 15'), a theory of the mind measure. The FEIT involves black-and-white photographs of 19 different individuals' faces (nine females/10 males) each depicting one of six different emotions (happiness, sadness, anger, surprise, fear, shame), shown one at a time for 15 s. After each stimulus, the participant should select which of the six emotions better describe the picture shown. The Awareness of Social Inference Test (TASIT) is a measure of basic emotion perception and complex social cognition. This test evaluates social cognition through videotaped vignettes designed to reflect the real life interactions.

  Pre (T0) and Post (T1) Intervention - 3 Months time frame

• General cognitive abilities

  General cognitive abilities will be evaluated with the Wechsler Adult Intelligence Scale-Revised (WAIS-R). This instrument is a revised form of the WAIS, a test that consisted of six verbal and five performance subtests. The WAIS-R uses four subtests (arithmetic, block design, picture completion, and information) to estimate verbal and performance IQ that are highly correlated with the full WAIS assessments.

  Pre (T0) and Post (T1) Intervention - 3 Months time frame

• Functional ability

  Functional ability will be assessed by the brief version of UCSD Performance-based Skills Assessment (UPSA-Brief, administration time = 15'), an instrument that measures participants' capacity to perform tasks similar to those encountered in daily life. The UPSA-B consists of two of the five subscales from the full UPSA: 1) Financial skills and 2) Communication skills. For the assessment of financial skills, participants are given fake money to handle (for example, they are asked to count them, make change, pay bills). Assessment of communication skills involves tasks in which participants use a disconnected landline telephone to simulate phone calls (e.g., doctor's office) to communicate requested or necessary information. The final score (calculated by summing the two subscales scores) ranges from 0 to 100, with higher scores indicating better functional capacity.

  Pre (T0) and Post (T1) Intervention - 3 Months time frame

• Functioning

  The Specific Level of Functioning Scale (SLOF, administration time = 20') will be used to evaluate the subject's functioning. This scale consists of 43 items and relies on data reported by an operator and on the direct observation of subejct's behaviors and functioning in several domains: (1) physical functioning, (2) personal care skills, (3) interpersonal relationships, (4) social acceptability, (5) activities of community living and (6) work skills.

  Pre (T0) and Post (T1) Intervention - 3 Months time frame

• Quality of Life assessment

  Quality of life will be measured through the Quality of Life Scale (QOLS, administration time = 5'), a semi-structured interview, composed by 21 items, designed to assess four different areas of psychosocial adjustment, including Interpersonal Relations, Instrumental Role (e.g., work, school, homemaker), Intrapsychic Foundations (e.g., motivation, sense of purpose), and Common Objects and Activities (e.g., owning a watch, use of public transportation).

  Pre (T0) and Post (T1) Intervention - 3 Months time frame

Study Arms (2)

SoCIAL Group

EXPERIMENTAL

Subjects will conduct SoCIAL programme once a week, for a total of 10 weeks. Every session consists of two different modules: 1) a training programme that helps patients recognize emotions and important social signals (such as facial expressions and prosody) and develop strategy focused on the Theory of Mind; 2) a training in narrative enhancement. Time of administration for both modules is 30 minutes; the operator, however, can choose to focus the session on one module rather than the other, based on the subject's specific needs.

Behavioral: Social Skills and Neurocognitive Individualized Training (SoCIAL); Other: Treatmment-as-usual

Control Group - Treatment-as-usual (TAU)

ACTIVE COMPARATOR

Subjects that will be randomized in this group will receive their treatment as usual for the whole length of the study (10 weeks). TAU includes all the psychiatric therapies (pharmacological, psychological, occupational etc) that subjects may have begun before study's enrollment.

Other: Treatmment-as-usual

Interventions

Social Skills and Neurocognitive Individualized Training (SoCIAL) BEHAVIORAL

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.

SoCIAL Group

Treatmment-as-usual OTHER

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.

Control Group - Treatment-as-usual (TAU); SoCIAL Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of schizophrenia/schizoaffective disorder according to DSM-V criteria, in stabilized phase of the disease;
• Illness duration \<10 years;
• No major pharmacological treatment modifications in the last 3 months;
• Minimum 5 years of education.

You may not qualify if:

• Organic diseases that cause disabilities;
• Usual consumption of alcohol and drugs.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Department of Psychiatry - University of Campania "Luigi Vanvitelli"

Napoli, 80138, Italy

Location

Related Publications (89)

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MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Mario Maj, MD, PhD

  Department of Psychiatry - University of Campania "Luigi Vanvitelli"

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 23, 2021
• Study Start: January 10, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)