Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, 1025 Queen St West, Toronto, ON, Canada.
Department of Psychiatry, Temerty Faculty of Medicine, University of Toronto, Toronto, Canada.
BMC Psychiatry. 2023 Jun 16;23(1):444. doi: 10.1186/s12888-023-04904-8.
Psychosis treatment guidelines recommend cognitive behaviour therapy (CBT) and family intervention (FI), for all patients with first episode psychosis (FEP), though guidance borrows heavily from literature in adults from high income countries. To our knowledge, there are few randomized controlled trials (RCTs) examining the comparative effect of these commonly endorsed psychosocial interventions in individuals with early psychosis from high-income countries and no such trials from low and middle-income countries (LMICs). The present study aims to confirm the clinical-efficacy and cost-effectiveness of delivering culturally adapted CBT (CaCBT) and culturally adapted FI (CulFI) to individuals with FEP in Pakistan.
A multi-centre, three-arm RCT of CaCBT, CulFI, and treatment as usual (TAU) for individuals with FEP (n = 390), recruited from major centres across Pakistan. Reducing overall symptoms of FEP will be the primary outcome. Additional aims will include improving patient and carer outcomes and estimating the economic impact of delivering culturally appropriate psychosocial interventions in low-resource settings. This trial will assess the clinical-efficacy and cost-effectiveness of CaCBT and CulFI compared with TAU in improving patient (positive and negative symptoms of psychosis, general psychopathology, depressive symptoms, quality of life, cognition, general functioning, and insight) and carer related outcomes (carer experience, wellbeing, illness attitudes and symptoms of depression and anxiety).
A successful trial may inform the rapid scale up of these interventions not only in Pakistan but other low-resource settings, to improve clinical outcomes, social and occupational functioning, and quality of life in South Asian and other minority groups with FEP.
NCT05814913.
精神病治疗指南建议对首发精神病（FEP）患者进行认知行为疗法（CBT）和家庭干预（FI），尽管该指南主要借鉴了来自高收入国家的成人文献。据我们所知，在来自高收入国家的早期精神病患者中，很少有随机对照试验（RCT）来检验这些普遍认可的心理社会干预措施的比较效果，来自中低收入国家（LMICs）的 RCT 更是没有。本研究旨在确认对来自巴基斯坦的 FEP 患者进行文化适应性 CBT（CaCBT）和文化适应性 FI（CulFI）的临床疗效和成本效益。
一项多中心、三臂 RCT，对来自巴基斯坦各大中心的 390 名 FEP 患者进行 CaCBT、CulFI 和常规治疗（TAU）的比较。减少 FEP 的整体症状将是主要结果。其他目的还包括改善患者和照顾者的结局，并评估在资源有限的环境中提供文化上适当的心理社会干预的经济影响。本试验将评估 CaCBT 和 CulFI 与 TAU 相比，在改善患者（精神病的阳性和阴性症状、一般精神病学、抑郁症状、生活质量、认知、一般功能和洞察力）和照顾者相关结局（照顾者体验、幸福感、疾病态度和抑郁及焦虑症状）方面的临床疗效和成本效益。
一项成功的试验不仅可以为这些干预措施在巴基斯坦的快速推广提供信息，而且可以为其他资源有限的环境提供信息，以改善南亚和其他少数民族 FEP 患者的临床结局、社会和职业功能以及生活质量。
NCT05814913。
