Wölwer Wolfgang, Frommann Nicole, Lowe Agnes, Kamp Daniel, Weide Karolin, Bechdolf Andreas, Brockhaus-Dumke Anke, Hurlemann Rene, Muthesius Ana, Klingberg Stefan, Hellmich Martin, Schmied Sabine, Meyer-Lindenberg Andreas
Department of Psychiatry and Psychotherapy, Medical Faculty, University of Düsseldorf, Düsseldorf, Germany.
Department of Psychiatry, Psychotherapy and Psychosomatic Medicine Incorporating FRITZ and Soulspace, Vivantes Klinikum Am Urban, Berlin, Germany.
Front Psychiatry. 2022 Jun 21;13:909370. doi: 10.3389/fpsyt.2022.909370. eCollection 2022.
Although clinically effective treatment is available for schizophrenia, recovery often is still hampered by persistent poor psychosocial functioning, which in turn is limited by impairments in neurocognition, social cognition, and social behavioral skills. Although cognitive remediation has shown general efficacy in improving cognition and social functioning, effects still need to be improved and replicated in appropriately powered, methodologically rigorous randomized controlled trials (RCTs). Existing evidence indicates that effects can most likely be optimized by combining treatment approaches to simultaneously address both social cognitive and social behavioral processes.
To assess whether Integrated Social Cognitive and Behavioral Skill Therapy (ISST) is more efficacious in improving functional outcome in schizophrenia than the active control treatment Neurocognitive Remediation Therapy (NCRT).
The present study is a multicenter, prospective, rater-blinded, two-arm RCT being conducted at six academic study sites in Germany. A sample of 180 at least partly remitted patients with schizophrenia are randomly assigned to either ISST or NCRT. ISST is a compensatory, strategy-based program that targets social cognitive processes and social behavioral skills. NCRT comprises mainly drill and practice-oriented neurocognitive training. Both treatments consist of 18 sessions over 6 months, and participants are subsequently followed up for another 6 months. The primary outcome is all-cause discontinuation over the 12-month study period; psychosocial functioning, quality of life, neurocognitive and social cognitive performance, and clinical symptoms are assessed as secondary outcomes at baseline before randomization (V1), at the end of the six-month treatment period (V6), and at the six-month follow-up (V12).
This RCT is part of the German Enhancing Schizophrenia Prevention and Recovery through Innovative Treatments (ESPRIT) research network, which aims at using innovative treatments to enhance prevention and recovery in patients with schizophrenia. Because this study is one of the largest and methodologically most rigorous RCTs on the efficacy of cognitive remediation approaches in schizophrenia, it will not only help to identify the optimal treatment options for improving psychosocial functioning and thus recovery in patients but also allow conclusions to be drawn about factors influencing and mediating the effects of cognitive remediation in these patients.
ClinicalTrials.gov NCT02678858, German Study Register DRKS 00010033.
尽管精神分裂症有临床有效的治疗方法，但康复往往仍受到持续存在的心理社会功能不佳的阻碍，而心理社会功能不佳又受到神经认知、社会认知和社会行为技能损害的限制。尽管认知康复在改善认知和社会功能方面已显示出总体疗效，但仍需要在样本量充足、方法严谨的随机对照试验（RCT）中进一步提高疗效并进行重复验证。现有证据表明，通过结合治疗方法同时解决社会认知和社会行为过程，最有可能优化治疗效果。
评估综合社会认知与行为技能疗法（ISST）在改善精神分裂症功能结局方面是否比积极对照治疗神经认知康复疗法（NCRT）更有效。
本研究是一项在德国六个学术研究地点进行的多中心、前瞻性、评估者盲法、双臂随机对照试验。180名至少部分缓解的精神分裂症患者被随机分配到ISST组或NCRT组。ISST是一个基于策略的补偿性项目，针对社会认知过程和社会行为技能。NCRT主要包括以训练和练习为主的神经认知训练。两种治疗均在6个月内进行18次治疗，随后对参与者进行另外6个月的随访。主要结局是12个月研究期内的全因停药；心理社会功能、生活质量、神经认知和社会认知表现以及临床症状在随机分组前的基线（V1）、6个月治疗期结束时（V6）和6个月随访时（V12）作为次要结局进行评估。
这项随机对照试验是德国通过创新治疗增强精神分裂症预防与康复（ESPRIT）研究网络的一部分，该网络旨在利用创新治疗方法增强精神分裂症患者的预防和康复效果。由于本研究是关于精神分裂症认知康复方法疗效的最大规模且方法最严谨的随机对照试验之一，它不仅有助于确定改善患者心理社会功能从而促进康复的最佳治疗方案，还能就影响和介导这些患者认知康复效果的因素得出结论。
ClinicalTrials.gov NCT02678858，德国研究注册DRKS 00010033。
