Objective: Adjunctive psychological interventions improve outcomes in bipolar disorder (BD), but people in latter stages likely have different clinical needs. The objective here was to test the hypothesis that for people with ≥10 episodes of BD, a brief online mindfulness-based intervention (ORBIT 2.0) improves quality of life (QoL) relative to a Psychoeducation control. Method: A rater-masked, pragmatic superiority randomized clinical trial compared ORBIT 2.0 with active control. Both interventions were 5-week coach-supported programs with treatment as usual continued. Inclusion criteria included age 18-65 years, confirmed diagnosis of BD, and history of ≥10 episodes. Measures were collected at baseline, postintervention, and 3- and 6-month follow-ups. The main outcome was QoL, measured on the Brief Quality of Life in Bipolar Disorder (Brief QoL.BD) at 5 weeks, using intention-to-treat analyses. Results: Among N = 302 randomized participants, the primary hypothesis was not supported (Treatment × Time β = -0.69, 95% CI [-2.69, 1.31], p = .50). The main effect of Time was not significant in either condition, indicating no improvement in either group. Recruitment was feasible, the platform was safe, both interventions were highly acceptable, but usage was suboptimal. Post hoc analyses found both interventions effective for participants not in remission from depression at baseline. Conclusions: In people with late-stage BD, an online mindfulness-based intervention was not superior to psychoeducational control in improving QoL. Online delivery was found to be safe and acceptable. Future interventions may need to be higher intensity, address engagement challenges, and target more symptomatic individuals. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

中文翻译：

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基于正念的在线干预改善晚期双相情感障碍的生活质量：一项随机临床试验。

目的：辅助心理干预可改善双相情感障碍 (BD) 的预后，但处于后期阶段的人可能有不同的临床需求。此处的目的是检验以下假设：对于 BD 发作 10 次以上的人，与心理教育控制相比，基于正念的简短在线干预 (ORBIT 2.0) 可改善生活质量 (QoL)。方法：评估者不知情的、务实优势随机临床试验将 ORBIT 2.0 与主动对照进行了比较。两种干预措施都是为期 5 周的教练支持计划，照常继续进行治疗。纳入标准包括年龄 18-65 岁、确诊 BD 和≥10 次发作史。在基线、干预后以及 3 个月和 6 个月的随访中收集了测量值。主要结果是 QoL，根据双相情感障碍的简要生活质量 (Brief QoL. BD) 在第 5 周，使用意向治疗分析。结果：在 N = 302 名随机参与者中，不支持主要假设（治疗 × 时间 β = -0.69，95% CI [-2.69, 1.31]，p = .50）。时间的主效应在任一条件下都不显着，表明任一组都没有改善。招募是可行的，平台是安全的，两种干预措施都是高度可接受的，但使用情况并不理想。事后分析发现这两种干预措施对基线时未从抑郁症缓解的参与者有效。结论：对于晚期 BD 患者，基于在线正念的干预在改善 QoL 方面并不优于心理教育控制。在线交付被认为是安全和可接受的。未来的干预可能需要更高强度，应对参与挑战，并针对更多有症状的人。（PsycInfo 数据库记录 (c) 2021 APA，保留所有权利）。