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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Positive Symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Organic diseases that cause disabilities;
- •Usual consumption of alcohol and drugs.
结局指标
主要结局
Positive Symptoms
时间窗: Pre (T0) and Post (T1) Intervention - 3 Months time frame
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).
Neurocognitive functions
时间窗: Pre (T0) and Post (T1) Intervention - 3 Months time frame
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).
Functioning
时间窗: Pre (T0) and Post (T1) Intervention - 3 Months time frame
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.
Social cognition
时间窗: Pre (T0) and Post (T1) Intervention - 3 Months time frame
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.
Negative Symptoms
时间窗: Pre (T0) and Post (T1) Intervention - 3 Months time frame
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).
Disorganization
时间窗: Pre (T0) and Post (T1) Intervention - 3 Months time frame
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).
General cognitive abilities
时间窗: Pre (T0) and Post (T1) Intervention - 3 Months time frame
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.
Quality of Life assessment
时间窗: Pre (T0) and Post (T1) Intervention - 3 Months time frame
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).
Functional ability
时间窗: Pre (T0) and Post (T1) Intervention - 3 Months time frame
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.
次要结局
未报告次要终点
研究者
Prof. Silvana Galderisi
Professor
University of Campania "Luigi Vanvitelli"