远程医疗组对原发性脑肿瘤的认知行为疗法（CBT-I）：一项单臂 II 期可行性和概念验证试验的主要结果。
Telehealth group Cognitive-Behavioral Therapy for Insomnia (CBT-I) in primary brain tumor: Primary outcomes from a single-arm phase II feasibility and proof-of-concept trial.
机构信息
Department of Neurology, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.
Massey Comprehensive Cancer Center, Virginia Commonwealth University, Richmond, Virginia, USA.
出版信息
Neuro Oncol. 2024 Mar 4;26(3):516-527. doi: 10.1093/neuonc/noad193.
BACKGROUND
Cognitive-Behavioral Therapy for Insomnia (CBT-I), the frontline treatment for insomnia, has yet to be evaluated among patients with primary brain tumors (PwPBT) despite high prevalence of sleep disturbance in this population. This study aimed to be the first to evaluate the feasibility, safety, and acceptability of implementing telehealth group CBT-I as well as assessing preliminary changes in subjective sleep metrics in PwPBT from baseline to follow-up.
METHODS
Adult PwPBT were recruited to participate in six 90-min telehealth group CBT-I sessions. Feasibility was assessed by rates of screening, eligibility, enrollment, and data completion. Safety was measured by participant-reported adverse events. Acceptability was assessed by retention, session attendance, satisfaction, recommendation of program to others, and qualitative feedback. Participant subjective insomnia severity, sleep quality, and fatigue were assessed at baseline, post intervention, and 3-month follow-up.
RESULTS
Telehealth group CBT-I was deemed safe. Following the 76% screening rate, 85% of interested individuals met study eligibility and 98% enrolled (N = 44). Ninety-one percent of enrolled participants completed measures at baseline, 79% at post intervention, and 73% at 3-month follow-up. Overall, there was an 80% retention rate for the 6-session telehealth group CBT-I intervention. All participants endorsed moderate-to-strong treatment adherence and 97% reported improved sleep. Preliminary pre-post intervention effects demonstrated improvements in subjective insomnia severity, sleep quality, and fatigue with large effect sizes. These effects were maintained at follow-up.
CONCLUSIONS
Results of this proof-of-concept trial indicate that telehealth group CBT-I is feasible, safe, and acceptable among PwPBT, providing support for future randomized controlled pilot trials.
背景
认知行为疗法治疗失眠（CBT-I）是失眠的一线治疗方法，但在原发性脑肿瘤患者（PwPBT）中尚未得到评估，尽管该人群的睡眠障碍发生率很高。本研究旨在首次评估远程医疗团体认知行为疗法治疗失眠的可行性、安全性和可接受性，并评估 PwPBT 从基线到随访时主观睡眠指标的初步变化。
方法
招募成年 PwPBT 参加六次 90 分钟的远程医疗团体认知行为疗法治疗失眠的课程。通过筛查、合格性、入组和数据完成的比率来评估可行性。通过参与者报告的不良事件来衡量安全性。通过保留率、课程出勤率、满意度、向他人推荐该方案以及定性反馈来评估可接受性。在基线、干预后和 3 个月随访时评估参与者的主观失眠严重程度、睡眠质量和疲劳。
结果
远程医疗团体认知行为疗法被认为是安全的。在 76%的筛查率之后，85%感兴趣的个体符合研究资格，98%入组（N=44）。91%的入组参与者在基线时完成了测量，79%在干预后完成，73%在 3 个月随访时完成。总体而言，6 次远程医疗团体认知行为疗法干预的保留率为 80%。所有参与者都表示中度至强烈的治疗依从性，97%的人报告睡眠改善。初步的干预前后效果显示，主观失眠严重程度、睡眠质量和疲劳均有改善，且具有较大的效应量。这些效果在随访时得以维持。
结论
这项概念验证试验的结果表明，远程医疗团体认知行为疗法治疗失眠在 PwPBT 中是可行、安全和可接受的，为未来的随机对照试验提供了支持。
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