Background: Schizophrenia is a lifelong illness that requires long-term treatment and caregiving. Family psychoeducation (FP) has been shown to lessen caregiver burden, improve caregiver functioning, and improve outcomes in patients. However, the impact of FP delivered specifically to caregivers on patient outcomes has not been well explored, particularly for early schizophrenia. Furthermore, there is a lack of research examining the benefits of telehealth-based psychoeducation for caregivers on either patient or caregiver outcomes. Objective: The Family Intervention in Recent-Onset Schizophrenia Treatment (FIRST) study is a randomized controlled trial of patients with schizophrenia spectrum disorders and their caregivers, which is designed to evaluate the effect of telehealth-based, caregiver-focused, study-provided psychoeducation versus usual care (UC) on patient treatment failure (TF). The impact of study-provided psychoeducation on caregiver burden is also investigated. Methods: Eligible patients and their designated caregivers were randomly assigned to either the study-provided psychoeducation (≤16 sessions of telehealth-based psychoeducation over 6 months) or UC group, stratified by antipsychotic treatment (paliperidone palmitate or oral antipsychotic). The major TF events (ie, psychiatric hospitalization or intervention, arrest or incarceration, and suicide attempts) were assessed at 3, 6, and 12 months after baseline. A proportional means model using mean cumulative function was used to assess between-group differences in the mean cumulative number of TF events over 12 months. Caregiver burden was assessed using the Involvement Evaluation Questionnaire and 12-item Short Form Health Survey. Results: A total of 148 pairs of participants were enrolled in the study, of whom 96 (64.9%) patients and 94 (63.5%) caregivers completed the 12-month follow-up. The mean number of sessions in the study-provided psychoeducation group was 7.7 (SD 5.9). No differences were observed between the study-provided psychoeducation and UC groups in patient outcomes (rates of TF: 70% vs 67%; P=.90) or measures of caregiver burden (assessment of caregiver distress and physical and mental health). However, post hoc analyses revealed lower relapse rates in patients who received paliperidone palmitate than in those who received oral antipsychotics at all time points. Although the FIRST study did not meet the primary end point, several key lessons were identified to inform future caregiver-focused, telehealth-based FP interventions. Lack of study-provided psychoeducation, focus on caregiver-only intervention, difficulties with enrollment, and caregiver–treatment team coordination may have affected the outcomes of the FIRST study. Conclusions: Key insights from the FIRST study suggest the potential importance of supporting sufficient caregiver engagement; communication between clinicians, patients, and family members regarding treatment plans; and solidifying the relationship between clinicians providing psychoeducation to the caregiver and patient treatment team. Trial Registration: ClinicalTrials.gov NCT02600741; http://clinicaltrials.gov/ct2/show/NCT02600741

中文翻译：

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照顾者远程医疗心理教育：近期精神分裂症治疗研究中的家庭干预

背景：精神分裂症是一种需要长期治疗和护理的终身疾病。家庭心理教育 (FP) 已被证明可以减轻照顾者的负担、改善照顾者的功能并改善患者的预后。然而，专门提供给护理人员的 FP 对患者预后的影响尚未得到很好的探索，特别是对于早期精神分裂症。此外，缺乏研究来检验基于远程医疗的心理教育对护理人员或护理人员结果的益处。客观的：近期发作的精神分裂症治疗中的家庭干预 (FIRST) 研究是一项针对精神分裂症谱系障碍患者及其看护者的随机对照试验，旨在评估基于远程医疗、以看护者为中心、研究提供的心理教育与常规治疗相比的效果对患者治疗失败 (TF) 的护理 (UC)。还调查了研究提供的心理教育对照顾者负担的影响。方法：符合条件的患者及其指定的护理人员被随机分配到研究提供的心理教育（6 个月内≤16 次基于远程医疗的心理教育）或 UC 组，按抗精神病药物治疗（棕榈酸帕利哌酮或口服抗精神病药物）分层。在基线后 3、6 和 12 个月评估主要的 TF 事件（即精神病住院或干预、逮捕或监禁和自杀企图）。使用平均累积函数的比例平均模型用于评估 12 个月内 TF 事件平均累积数的组间差异。使用参与评估问卷和 12 项简短健康调查评估照顾者负担。结果：共有 148 对参与者参加了研究，其中 96 名（64.9%）患者和 94 名（63.5%）护理人员完成了 12 个月的随访。研究提供的心理教育组的平均会话数为 7.7 (SD 5.9)。研究提供的心理教育组和 UC 组之间在患者结局方面没有观察到差异（TF 率：70% vs 67%；P=.90）或照顾者负担的措施（评估照顾者的痛苦和身心健康）。然而，事后分析显示，在所有时间点，接受帕利哌酮棕榈酸酯的患者的复发率均低于接受口服抗精神病药的患者。尽管 FIRST 研究未达到主要终点，但确定了几个关键经验教训，为未来以护理人员为中心、基于远程医疗的 FP 干预措施提供信息。缺乏研究提供的心理教育、只关注照顾者的干预、入组困难以及照顾者-治疗团队的协调可能影响了 FIRST 研究的结果。结论：FIRST 研究的主要见解表明支持足够的护理人员参与的潜在重要性；临床医生、患者和家庭成员之间就治疗计划进行沟通；并巩固为护理人员和患者治疗团队提供心理教育的临床医生之间的关系。试验注册： ClinicalTrials.gov NCT02600741；http://clinicaltrials.gov/ct2/show/NCT02600741