Departments of Cognitive Behavioral Physiology, Chiba University Graduate School of Medicine School of Medicine, Chiba, Japan
Department of Rehabilitation, Faculty of Health Care and Medical Sports, Teikyo Heisei University - Chiba Campus, Ichihara, Japan.
BMJ Open. 2023 Sep 11;13(9):e069734. doi: 10.1136/bmjopen-2022-069734.
Cognitive behavioural therapy for psychosis (CBTp) has demonstrated effectiveness in reducing positive symptoms, improving depression, enhancing coping skills and increasing awareness of illness. However, compared with cognitive behavioural therapy for depression and anxiety, the spread of CBTp in clinical practice is minimal. The present study designed a randomised controlled trial (RCT) research protocol to evaluate whether real-time remote video-conference CBTp (vCBTp) could facilitate access to psychosocial interventions and effectively improve symptoms compared with usual care (UC) for patients with schizophrenia.
This exploratory RCT will consist of two parallel groups (vCBTp+UC and UC alone) of 12 participants (n=24) diagnosed with schizophrenia, schizoaffective disorder or paranoid disorder, who remain symptomatic following pharmacotherapy. Seven 50-min weekly vCBTp interventions will be administered to test efficacy. The primary outcome will be the positive and negative syndrome scale score at week 8. The secondary outcome will be the Beck Cognitive Insight Scale to assess insight, the Patient Health Questionnaire-9 to assess depression, the Generalised Anxiety Disorder-7 to assess anxiety, the 5-level EuroQol 5-dimensional questionnaire to assess quality of life and the Impact of Event Scale-Revised to assess subjective distress about a specific stressful life event. We will take all measurements at 0 weeks (baseline) and at 8 weeks (post-intervention), and apply intention-to-treat analysis.
We will conduct this study in the outpatient department of Cognitive Behavioral Therapy Center at Chiba University Hospital. Further, all participants will be informed of the study and will be asked to sign consent forms. We will report according to the Consolidated Standards of Reporting Trials.
UMIN000043396.
针对精神病的认知行为疗法（CBTp）已被证明可有效减轻阳性症状、改善抑郁、增强应对技能并提高对疾病的认识。然而，与针对抑郁和焦虑的认知行为疗法相比，CBTp 在临床实践中的应用极为有限。本研究设计了一项随机对照试验（RCT）研究方案，以评估实时远程视频会议认知行为疗法（vCBTp）是否可促进心理社会干预措施的实施，并与常规护理（UC）相比，有效改善精神分裂症患者的症状。
本探索性 RCT 将包括两组平行组（vCBTp+UC 和 UC 组），每组各有 12 名参与者（n=24），这些参与者被诊断患有精神分裂症、分裂情感性障碍或偏执型障碍，且在药物治疗后仍存在症状。每周进行 7 次 50 分钟的 vCBTp 干预，以检验疗效。主要结局是第 8 周时的阳性和阴性症状量表评分。次要结局是贝克认知洞察力量表以评估洞察力、患者健康问卷-9 以评估抑郁、广泛性焦虑症-7 以评估焦虑、5 级欧洲五维健康量表以评估生活质量和修订后的事件影响量表-修订版以评估对特定压力生活事件的主观困扰。我们将在 0 周（基线）和 8 周（干预后）进行所有测量，并采用意向治疗分析。
我们将在千叶大学医院认知行为治疗中心的门诊部进行这项研究。此外，我们将告知所有参与者研究情况，并要求他们签署同意书。我们将根据临床试验报告标准进行报告。
UMIN000043396。
