背景:精神分裂症是一种需要长期治疗和护理的终生疾病。家庭心理教育(FP)已被证明可以减轻照顾者的负担,改善护理人员的功能,并改善患者的预后。然而,尚未很好地探讨专门向护理人员提供FP对患者预后的影响,特别是早期精神分裂症。此外,缺乏研究研究以远程健康为基础的心理教育对护理人员患者或护理人员结局的益处.
目的:新发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照顾者的随机对照试验,旨在评估基于远程医疗的效果,以照顾者为中心,研究提供的心理教育与常规护理(UC)对患者治疗失败(TF)。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次基于远程健康的心理教育)或UC组,通过抗精神病药物治疗(帕潘立酮棕榈酸酯或口服抗精神病药物)进行分层。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)在基线后3、6和12个月进行评估。使用平均累积函数的比例均值模型用于评估12个月内TF事件的平均累积数量的组间差异。使用参与评估问卷和12项简短形式的健康调查来评估照顾者的负担。
结果:共有148对参与者参加了研究,其中96例(64.9%)患者和94例(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次数为7.7(SD5.9)。研究提供的心理教育和UC组在患者结局(TF率:70%vs67%;P=.90)或照顾者负担(照顾者困扰和身心健康评估)方面没有差异。然而,事后分析显示,在所有时间点,接受棕榈酸帕潘立酮治疗的患者的复发率均低于接受口服抗精神病药物治疗的患者.尽管FIRST研究未达到主要终点,确定了几个关键的经验教训,以告知未来的照顾者,基于远程保健的FP干预。缺乏学习提供的心理教育,专注于仅照顾者的干预,入学困难,和照顾者-治疗团队的协调可能影响了FIRST研究的结果.
结论:来自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;临床医生之间的沟通,病人,和家庭成员关于治疗计划;并巩固提供心理教育的临床医生和病人治疗团队之间的关系。
背景:ClinicalTrials.govNCT02600741;http://clinicaltrials.gov/ct2/show/NCT02600741。
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.
BACKGROUND: ClinicalTrials.gov NCT02600741; http://clinicaltrials.gov/ct2/show/NCT02600741.