Schizophrenia Clinical Trial
Official title:
Comparative Effectiveness of Social Cognition and Interaction Training Program (SCIT) Versus Training of Affect Recognition Program (TAR) for Outpatients With Schizophrenia.
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).
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).
2. Methods
2.1. Participants Outpatients who met DSM-IV criteria for schizophrenia and schizoaffective
disorder (SCID-P; First et al. 1994) with stable symptoms in the range from 18 to 65 years
were included into the study. Patients were recruited from 4 Mental Healt Centers in Madrid,
Barcelona, Zaragoza and Teruel (Spain). All were clinically stable, 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. Exclusion
criteria were: 1. Disorders other than schizophrenia or schizoaffective disorder, according
to DSM-IV diagnosis criteria; 2. Additional axis-I or axis-II diagnosis; 3. Dependence to
alcohol or other drugs (except nicotine); 4. Serious somatic disorders or organic brain
damage; 5. Mental retardation or difficulty speaking or understanding the Spanish language.
The study was approved by the loval ethics committee and all participants gave their informed
consent. Overall 100 participants were randomized either to TAR group (n = 49) or to the SCIT
group (n = 51) (Consort diagram, Graphic 1).
2.1.1. Treatment
TAR is a 12-session training on facial affect recognition over a period of 6 weeks. Treatment
includes one therapist (psychiatrist or clinical psychologist) and 2 patients. It involves
neuropsychological strategies, such as restitution and compensation, as well as principles of
errorless learning, direct positive reinforcement, verbalization and self-instruction
(Frommann et al., 2003; Wölwer et al., 2005). The program is divided into three blocks,
whereas each block consists of 4 sessions: during the first block patients learn to identify
and discriminate the prototypical facial signs of the six basic emotions (happiness, sadness,
fear, disgust, anger and surprise). The next block aims at a more holistic processing mode
with fast decisions, relying on first impression, nonverbal processing and recognition of
facial expressions with small intensities. The third block deals with the role of facial
emotions in social, behavioral and situational context. Baseline assessments
(T0=pre-treatment) were performed after enrolment to the study and post treatment assessments
(T1=post-treatment) after the end of the training period (Sachs et al. 2012).
SCIT is a manual-based group intervention that is delivered in 20-24weekly, hour-long
sessions. Groups include two clinicians and six to ten patients. SCIT uses a combination of
psychoeducation, drill-and-repeat skill practice, strategy games, heuristic rehearsal, and
homework assignments to remediate deficits and decrease biases in social cognition. Each SCIT
group participant was encouraged to identify a 'practice partner', a family member or
acquaintance who was willing to practice SCIT skills with the participant weekly in lieu of,
or in addition to, traditional homework. SCIT clinicians attempted to reach practice partners
by phone each week to check -in and provide guidance in their efforts to support SCIT
participants' learning (Roberts et al. 2014).
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