Comparative Effectiveness of Social Cognition and Interaction Training Program (SCIT) Versus Training of Affect Recognition Program (TAR) for Outpatients With Schizophrenia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Face emotion recognition
研究概览
简要总结
The present work consists of a randomized clinical trial comparing the effectiveness of two interventions based on social cognition training in outpatients with schizophrenia. The investigators sought to compare the effect of a "targeted" (TAR) and a "broad-based" (SCIT) intervention on schizophrenia patients' performance in facial affect recognition, theory of mind and attributional style. Secondarily, the investigators compare the effect on symptomatology, general cognition and functioning. The main hypothesis was that the patient group receiving TAR would exhibit a greater improvement in emotion recognition performance at the post-intervention assessment in comparison to patients receiving the SCIT, and, conversely, patients receiving SCIT would show more effect in ToM and attributional style. To assess the durability of these effects, performance in measures of social cognition, basic cognitive functioning, symptomatology and functional capacity were assessed before (T0), after treatment (T1) and 3 months later (T2).
详细描述
In recent years, there has been an interest in the development of intervention programs focused on the social cognition for people with schizophrenia (Andres et al., 2001; P Penn et al. 2005). At least, five reviews and one meta-analysis have been conducted to date, which demonstrate promising results of the effectiveness of such interventions on social cognitive deficits and functional outcomes (Tan et al; 2016; Choi et al., 2009; Horan et al., 2008; Kurtz and Richardson, 2012; Statucka and Walder, 2013; Wolwer et al., 2010). Some approaches are focused on one specific domain of social cognition ("targeted" interventions, such as the Training in Affect Recognition (TAR, Wolwer et al., 2005), and others incorporate multiple domains to create more complex, eclectic programs ("broad-based" interventions, such as the Social Cognition and Interaction Training (SCIT; Penn et al. 2007; Kurtz & Richardson, 2012).
TAR (Frommann et al., 2003) is one of the social cognition interventions with greater empirical support (Statucka & Walder, 2016) and has been shown to effectively attenuate facial affect recognition deficits in patients with schizophrenia (Wölwer et al. 2005; Wölwer and Frommann 2011; Sachs et al. 2012; Luckhaus et al. 2013). TAR teaches compensation strategies using errorless learning principles, positive reinforcement, feature abstraction, self-instruction and, most importantly, verbalization of characteristic features of facial affect. In a randomized controlled trial, the TAR group achieved significant improvements in facial affect recognition -in particular in recognizing sad faces- and in the quality of life domain social relationship. Furthermore, the TAR training contributed to enhancing some aspects of cognitive functioning and negative symptoms (Sachs et al, 2012). In the other hand, SCIT is a 24-session manual-based group treatment, including elements of cognitive behavioral therapy and social skills training. It is designed for those with schizophrenia spectrum disorders to improve social functioning by enhancing social cognition. Across different studies and research groups, SCIT has been also shown to improve in emotion perception, theory of mind (ToM), and social functioning (Bartholomeusz et al., 2013; Combs et al., 2007; Hasson-Ohayon, 2014; Parker et al. 2013; Penn et al., 2007; Roberts & Penn, 2009; Roberts et al. 2010; Roberts et al., 2014, 2016; Wang et al., 2013).
The efficacy of both interventions has been demonstrated in randomized controlled trials compared to "treatment as usual", occupational therapy or cognitive remediation (Kurtz et al. 2016) but to date no study has compared the efficacy of two different social cognitive interventions (a direct comparison design). A more precise knowledge about the effect of each intervention on the 4 main domains of social cognition (affect recognition, theory of mind, attributional style and social perception) is needed, and this would enable to identify potential candidates for each program.
The present work consists of a randomized clinical trial comparing the effectiveness of two interventions based on social cognition training in outpatients with schizophrenia. The investigators sought to compare the effect of a "targeted" (TAR) and a "broad-based" (SCIT) intervention on schizophrenia patients' performance in facial affect recognition, theory of mind and attributional style. Secondarily, the investigators compare the effect on symptomatology, general cognition and functioning. The main hypothesis was that the patient group receiving TAR would exhibit a greater improvement in emotion recognition performance at the post-intervention assessment in comparison to patients receiving the SCIT, and, conversely, patients receiving SCIT would show more effect in ToM and attributional style. To assess the durability of these effects, performance in measures of social cognition, basic cognitive functioning, symptomatology and functional capacity were assessed before (T0), after treatment (T1) and 3 months later (T2).
- Methods
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
- Single (Outcomes Assessor)
盲法说明
Trained raters who were blind to treatment condition assessed participants on the following variables at baseline, post-treatment and 3-month follow-up
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients who met DSM-IV criteria for schizophrenia and schizoaffective disorder (SCID-P; First et al. 1994)
- •Clinical stability: without any psychiatric hospitalizations in the last 3 months, with the same antipsychotic medication during the previous 6 weeks, and no planned change in the drug regime for the next 3 months.
- •Age in the range from 18 to 65 years
排除标准
- •Disorders other than schizophrenia or schizoaffective disorder, according to DSM-IV diagnosis criteria;
- •Additional axis-I or axis-II diagnosis;
- •Dependence to alcohol or other drugs (except nicotine);
- •Serious somatic disorders or organic brain damage;
- •Mental retardation or difficulty speaking or understanding the Spanish language.
研究组 & 干预措施
TAR Training in affect recognition
Training in Affect Recognition it is a 12-session training on facial affect recognition over a period of 6 weeks.
干预措施: TAR (Behavioral)
SCIT Social cognition interactive
Psychosocial intervention based on the Spanish translation of the original SCIT (Social Cognition and Interaction Training) instruction manual (Combs & Penn; Lahera & Benito, in press).
干预措施: SCIT (Behavioral)
结局指标
主要结局
Face emotion recognition
时间窗: 24 weeks
Emotion recognition was measured with the Penn Emotion Recognition-40 (ER40) task, in which participants are asked to judge, one at a time, which emotion is shown on a series of 40 faces (Kohler et al, 2003).
次要结局
- Theory of Mind(24 weeks)
- Attributional Style(24 weeks)
- Functioning(24 weeks)
研究者
Guillermo Lahera
M.D., Ph.D. Assistant Professor of Psychiatry
University of Alcala
