Efficacy Study of a New Individualized Rehabilitation Programme for Social Cognition in Patients With Schizophrenia
Condition: Schizophrenia; Schizo Affective Disorder
MeSH terms: Schizophrenia; Mood Disorders; Psychotic Disorders
Study type: Interventional

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.
    

Intervention name(s): Social Skills and Neurocognitive Individualized Training (SoCIAL); Treatmment-as-usual
Intervention type(s): Behavioral; Other
Intervention description(s): SoCIAL is composed of two modules:
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.
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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cognitive remediation; psychiatric rehabilitation; social cognition