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针对偏头痛和抑郁症状患者的远程提供的简化正念认知疗法干预措施的可行性、可接受性和保真度。

Feasibility, acceptability, and fidelity of remote-delivered abbreviated mindfulness-based cognitive therapy interventions for patients with migraine and depressive symptoms.

作者信息

Seng Elizabeth K, Hill Jacob, Reeder Annie Kate, Visvanathan Pallavi, Wells Rebecca E, Lipton Richard B, Minen Mia, Shallcross Amanda J

机构信息

Yeshiva University, Bronx, New York, USA.

Albert Einstein College of Medicine, Bronx, New York, USA.

出版信息

Headache. 2025 Apr;65(4):545-557. doi: 10.1111/head.14857. Epub 2024 Oct 14.

Abstract

OBJECTIVE

This study was an open-label single-arm clinical trial evaluating the fidelity, feasibility, acceptability, and clinical signal of abbreviated mindfulness-based cognitive therapy (MBCT-brief) delivered either via telephone (MBCT-T) or by video conferencing (MBCT-V) for people with migraine and comorbid depressive symptoms.

BACKGROUND

Migraine is commonly comorbid with elevated depressive symptoms. MBCT reduces depressive symptoms and shows promise to reduce migraine-related disability. An abbreviated and remotely delivered version of MBCT could increase access to care.

METHODS

People with migraine and elevated depressive symptoms were recruited from a large urban health system. Participants were assigned in blocks of eight to receive an evidence-based MBCT-brief treatment, including eight weekly group classes and home practice delivered via telephone (MBCT-T) or video (MBCT-V); MBCT-T was randomly selected for the first block. Sessions were recorded and coded for treatment fidelity. Feasibility was assessed via session attendance (primary), homework completion, recruitment rate, and survey completion rate. Acceptability was assessed via the eight-item Client Satisfaction Questionnaire (CSQ-8; primary), the Credibility/Expectancy Questionnaire (CEQ), the System Usability Scale (SUS), and items assessing survey acceptability. Participants completed the Headache Disability Inventory (HDI) and Quick Inventory of Depressive Symptomatology-Self Report 16-item (QIDS-SR) at baseline, mid-treatment, and post-treatment. Feasibility and acceptability rates were compared to a priori benchmarks.

RESULTS

Participants (n = 16) were all female with a mean (standard deviation [SD]) age of 45 (13) years, the majority of whom identified as White (13/16, 81%) and non-Hispanic (14/16, 88%). The intervention met the a priori criteria set for therapist fidelity to treatment protocol (mean [SD] MBCT-Treatment Acceptability and Competence Scale Adherence score 2.9 [0.2]), feasibility (mean [SD] session attendance was 7.9/8 [0.3]), and acceptability (mean [SD] CSQ-8 score 28.8 [3.3]) for the entire sample and for each treatment arm. The usability of the remote-delivery system was high across study participants (mean [SD] SUS score 84.8 [11.0]). Survey procedures were broadly deemed acceptable, with at least 80% participants either endorsing "Agree" or "Strongly Agree" across all items. Using Wilcoxon tests, we observed significant reductions in both the HDI (pre-treatment median [interquartile range] score 63 [40, 70] vs. post-treatment 36 [26, 54], p = 0.004) and the QIDS-SR (pre-treatment median [interquartile range] score 8 [5, 13] vs. post-treatment 4 [3, 6], p = 0.003).

CONCLUSION

We found that remotely delivered MBCT-brief for migraine and depressive symptoms was feasible and acceptable to patients in both the telephone and video modalities. Intervention was associated with significant post-treatment reductions in headache-related disability and depressive symptomatology, findings that must be interpreted cautiously in the absence of a control group.

摘要

目的

本研究是一项开放标签单臂临床试验,旨在评估通过电话(MBCT-T)或视频会议(MBCT-V)为患有偏头痛和合并抑郁症状的患者提供简化版基于正念的认知疗法(MBCT-brief)的保真度、可行性、可接受性和临床信号。

背景

偏头痛通常与抑郁症状加重并存。MBCT可减轻抑郁症状,并有望减少与偏头痛相关的残疾。简化版且可远程提供的MBCT可能会增加获得治疗的机会。

方法

从一个大型城市卫生系统招募患有偏头痛和抑郁症状加重的患者。参与者按每组8人进行分组,接受基于证据的MBCT-brief治疗,包括8次每周一次的小组课程以及通过电话(MBCT-T)或视频(MBCT-V)进行的家庭练习;第一个组随机选择为MBCT-T。课程进行记录并编码以评估治疗保真度。通过课程出席率(主要指标)、家庭作业完成情况、招募率和调查完成率评估可行性。通过八项客户满意度问卷(CSQ-8;主要指标)、可信度/期望问卷(CEQ)、系统可用性量表(SUS)以及评估调查可接受性的项目评估可接受性。参与者在基线、治疗中期和治疗后完成头痛残疾量表(HDI)和抑郁症状快速自评量表16项(QIDS-SR)。将可行性和可接受率与预先设定的基准进行比较。

结果

参与者(n = 16)均为女性,平均(标准差[SD])年龄为45(13)岁,其中大多数人认定为白人(13/16,81%)且非西班牙裔(14/16,88%)。该干预措施符合为治疗师对治疗方案的保真度预先设定的标准(平均[SD]MBCT治疗可接受性和能力量表依从性得分2.9[0.2])、可行性(平均[SD]课程出席率为7.9/8[0.3])以及整个样本和每个治疗组的可接受性(平均[SD]CSQ-8得分28.8[3.3])。远程交付系统在所有研究参与者中的可用性较高(平均[SD]SUS得分84.8[11.0])。调查程序被广泛认为是可接受的,所有项目中至少80%的参与者选择“同意”或“强烈同意”。使用Wilcoxon检验,我们观察到HDI(治疗前中位数[四分位间距]得分63[40, 70]与治疗后36[26, 54],p = 0.004)和QIDS-SR(治疗前中位数[四分位间距]得分8[5, 13]与治疗后4[3, 6],p = 0.003)均有显著降低。

结论

我们发现,通过电话和视频方式为偏头痛和抑郁症状患者远程提供MBCT-brief是可行且可接受的。干预与治疗后头痛相关残疾和抑郁症状的显著减轻相关,但在没有对照组的情况下,这些结果必须谨慎解释。

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