Clinical trial NCT05130853: Efficacy Study of a New Individualized Rehabilitation Programme for Social Cognition in Patients With Schizophrenia
Official title: Social Cognition Individualized Activities Lab (SoCIAL) for the Training of Social Cognition and Narrative Enhancement in Patients With Schizophrenia: A Randomized Controlled Study to Assess Efficacy and Generalization to Real-life Functioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizo Affective Disorder
Keywords: cognitive remediation
psychiatric rehabilitation
social cognition
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: BACKGROUND:

In patients with schizophrenia an impairment in different cognitive domains has been well established. Cognitive impairment has been associated with poor social functioning and poor quality of life. Evidence has been reported suggesting that the impact of cognitive impairment in real-life functioning is even greater than the one exerted by positive and negative symptoms. Furthermore, this impairment can be detected throughout different phases of schizophrenia, such as the premorbid, prodromal and remission stages of the illness. From a neurobiological perspective, this impairment might be explained as the cumulative effect of abnormalities in neuronal maturation processes, neurodevelopment and neuroplasticity that could lead to defective cortico-cerebellar-thalamic-cortical circuits.

Among all the cognitive domains, Social Cognition (SC) was highlighted not only for its direct impact on functioning, but also for its key role in mediating the effects of the other cognitive domains on real-life functioning. SC represents a complex cognitive domain that underlies fundamental abilities for social interactions, such as the capacity to perceive, interpret and generate answers based on other people's intentions, emotions, and behaviors.

Studies regarding SC in schizophrenia identified 4 sub-domains impaired in affected subjects: emotion recognition, social role perception, theory of mind and attributional style.

Despite the key role that cognitive impairment plays in schizophrenia, the pharmacological options of treatment against them seem to have a marginal impact; consequently, a number of psychological treatments has been developed in order to get a significant improvement in the cognitive domains impairments, in quality of life and in real-life functioning. Specifically, the cognitive remediations programmes are mainly targeted in improving neurocognitive functions (such as attention, memory, learning) rather than obtaining a better outcome in SC, even if the early results in this field are promising.

Different approaches have been used to develop cognitive remediation programmes for SC: some of them, defined as "integrated", aim to train both SC domains and neurocognitive domains; other programmes, defined as "targeted", are designed to improve only specific SC domains. A meta-analysis of SC programmes showed that these interventions produce significant improvements in 2 of the 4 SC impaired domains in schizophrenia (facial emotion recognition and theory of mind), as well as in real life functioning and in negative symptoms.

The Department of Psychiatry of the University of Campania "Luigi Vanvitelli" developed an integrated group intervention, the Social Cognition Individualized Activities Lab (SoCIAL), with the purpose to improve both SC domains (recognition of emotions and theory of mind). In the pivotal study, SoCIAL was compared to a largely validated remediation programme for social abilities, the Social Skills and Neurocognitive Individualized Training. Results showed that participants that underwent the SoCIAL programme improved their SC abilities, together with a significant reduction of the avolition domain in negative symptomatology, compared to the control group.

Conversely, no difference was found among the two groups when looking at other clinical variables such as positive and disorganized symptoms, neurocognitive functions and real-life functioning. In particular, any of the participants in both groups showed an improvement in social functioning, probably due to the "rooftop effect", i.e. the high level of functioning that these patients already had before the treatment started.

The main limitations found for this programme concerned two aspects: 1) the conduction of the intervention in a group setting and 2) the role-play module. The group setting was considered to be bounding because: a) in a group session, it is harder to individualize the intervention, considering that it could be challenging to work on deficits shared by all participants); b) participants' recruitment could be complicated if some subjects refuse, or are unable, to attend group sessions. The role-play, a very useful technique for the treatment of social abilities, does not seem to have the same results when it comes to SC; the SoCIAL programme, in fact, aims to improve one's capacity to recognize other people's emotions, thoughts and beliefs. During the role-play simulation, subjects may experience frustration in case they are unable to understand the role played by another patient during the simulation, considering that the intentions of the "actor" should be hidden to the subject.

Additionally, literature has recently identified an interesting technique that could help individuals affected by schizophrenia train their narrative ability, i.e. narrative enhancement. A consensual definition of "narrative abilities" is complicated by the multitude of theoretical approaches. According to the phenomenological perspective, narrative abilities consist of two different components: phenomenological continuity and narrative continuity. Phenomenological continuity is the ability to make "mental time travel", both reliving past experiences and pre-experiencing events that may occur in the future. Narrative continuity is the sense of personal continuity due to the ability to create a personal story (biography) that is coherent and adherent to the facts. These abilities are impaired in schizophrenia and several studies have shown a correlation between narrative abilities and metacognition. Narrative and metacognitive abilities play a substantial role in determining the poor quality of life for people with schizophrenia and low personal narrative ability is also associated with negative and depressive symptoms. Some studies used the narrative enhancement technique in a rehabilitation programme defined as "integrated", since it trained both neurocognitive and narrative abilities. The results are encouraging, considering that this technique seems to considerably decrease internalized stigma and to improve quality of life for participants, even when compared to other psychological and rehabilitative programmes.

This project aims to evaluate the efficacy of the SoCIAL programme in a larger sample. Moreover, it will be administered individually (not in a group setting) and the narrative enhancement technique will replace the role-play session (more info available in "Social Cognitive Individualized Activities Lab" paragraph, in "Methods" section). Lastly, the efficacy of the programme will be evaluated by comparing the SoCIAL's participants vs a group of patients treated as usual.

AIMS:

1. to modify and implement the individualized cognitive remediation programme (SOcial Cognition Individualized Activities Lab, SoCIAL)
2. to compare the efficacy of SoCIAL programme vs (treatment-as-usual (TAU) in patients that have been diagnosed with schizophrenia/schizoaffective disorder (based on DSM-V criteria) with illness durations \<10 years. Efficacy will be evaluated with primary and secondary outcomes: 1) the primary outcome is to evaluate SoCIAL efficacy on patients' social cognition, negative symptoms, level of functioning and quality of life; 2) the secondary outcome is to evaluate improvements in positive and disorganized symptoms of schizophrenia, functional capacity and cognition.

PROCEDURE:

The study will be carried out at The Department of Psychiatry of the University of Campania "Luigi Vanvitelli" and the Department of Mental Health and Addictions, ASST Fatebenefratelli Sacco that will enroll outclinic patients with a diagnosis of schizophrenia/schizoaffective disorder according to DSM-V criteria, confirmed by Structured Clinical Interview for DSM-5 - Patient version (SCID-I-P) There will be 80 enrolled subjects (40 for each center). Subjects will be randomly assigned to the SoCIAL or the TAU group. Overall, 40 patients (20 for each center) will be assigned to SoCIAL and 40 (20 for each center) to TAU. Subjects will be evaluated before the programme starts and as soon as it ends. Following eligibility and baseline assessment participants are randomly assigned to either an intervention or control (TAU) group using an Excel spreadsheet. The investigators stratified randomisation considering age, gender and years of education.

The study will have a total length of 12 months, divided in these phases:

1) Operators will be trained in evaluating neurocognitive functions, social cognition, functional capacity and real life functioning ; 2) Operators will also be trained in SoCIAL programme's practice; 3) Recruitment of patients and randomization (in both centers); 4) assessment of neurocognitive functions, social cognition, functional capacity and real life functioning for enrolled patients; 5) implementation of interventions; 6) assessment of neurocognitive functions, social cognition, functional capacity and real life functioning in subjects at the end of the programme for both group (SoCIAL programme vs TAU); 7) final evaluation and data analysis.

DATA ANALYSIS:

An assessment of the statistical power of this study was performed by an effect size's analysis of the studies included in a recent meta-analysis (Kurtz and Richardson 2012). The results are very satisfactory: with a statistical power ≥0.8 and a significance level of \<.05, our study needs a total sample of 68 subjects as against the 80 subjects that the investigators are recruiting.

Neuropsychological, psychopathological and cognitive functioning evaluations will be conducted pre and post interventions. Statistical analysis will be conducted by ANOVA for repeated measures, focusing on the role played by different types of interventions in each group regarding the aforementioned domains.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Positive Symptoms
timeFrame: Pre (T0) and Post (T1) Intervention - 3 Months time frame
measure: Negative Symptoms
timeFrame: Pre (T0) and Post (T1) Intervention - 3 Months time frame
measure: Disorganization
timeFrame: Pre (T0) and Post (T1) Intervention - 3 Months time frame
measure: Neurocognitive functions
timeFrame: Pre (T0) and Post (T1) Intervention - 3 Months time frame
measure: Social cognition
timeFrame: Pre (T0) and Post (T1) Intervention - 3 Months time frame
measure: General cognitive abilities
timeFrame: Pre (T0) and Post (T1) Intervention - 3 Months time frame
measure: Functional ability
timeFrame: Pre (T0) and Post (T1) Intervention - 3 Months time frame
measure: Functioning
timeFrame: Pre (T0) and Post (T1) Intervention - 3 Months time frame
measure: Quality of Life assessment
timeFrame: Pre (T0) and Post (T1) Intervention - 3 Months time frame
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Department of Psychiatry - University of Campania "Luigi Vanvitelli"
Study officials:
affiliation: Department of Psychiatry - University of Campania "Luigi Vanvitelli"
name: Mario Maj, MD, PhD
role: STUDY_DIRECTOR
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