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在线正念认知疗法治疗残留抑郁症状患者的结局:一项随机临床试验。

Outcomes of Online Mindfulness-Based Cognitive Therapy for Patients With Residual Depressive Symptoms: A Randomized Clinical Trial.

机构信息

Graduate Department Psychological Clinical Science, University of Toronto Scarborough, Toronto, Ontario, Canada.

University of Colorado Boulder, Boulder.

出版信息

JAMA Psychiatry. 2020 Jun 1;77(6):563-573. doi: 10.1001/jamapsychiatry.2019.4693.

Abstract

IMPORTANCE

Patients with residual depressive symptoms face a gap in care because few resources, to date, are available to manage the lingering effects of their illness.

OBJECTIVE

To evaluate the effectiveness for treating residual depressive symptoms with Mindful Mood Balance (MMB), a web-based application that delivers mindfulness-based cognitive therapy, plus usual depression care compared with usual depression care only.

DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was conducted in primary care and behavioral health clinics at Kaiser Permanente Colorado, Denver. Adults identified with residual depressive symptoms were recruited between March 2, 2015, and November 30, 2018. Outcomes were assessed for a 15-month period, comprising a 3-month intervention interval and a 12-month follow-up period.

INTERVENTIONS

Patients were randomized to receive usual depression care (UDC; n = 230) or MMB plus UDC (n = 230), which included 8 sessions delivered online for a 3-month interval plus minimal phone or email coaching support.

MAIN OUTCOMES AND MEASURES

Primary outcomes were reduction in residual depressive symptom severity, assessed using the Patient Health Questionaire-9 (PHQ-9); rates of depressive relapse (PHQ-9 scores ≥15); and rates of remission (PHQ-9 scores <5). Secondary outcomes included depression-free days, anxiety symptoms (General Anxiety Disorder-7 Item Scale), and functional status (12-Item Short Form Survey).

RESULTS

Among 460 randomized participants (mean [SD] age, 48.30 [14.89] years; 346 women [75.6%]), data were analyzed for the intent-to-treat sample, which included 362 participants (78.7%) at 3 months and 330 (71.7%) at 15 months. Participants who received MMB plus UDC had significantly greater reductions in residual depressive symptoms than did those receiving UDC only (mean [SE] PHQ-9 score, 0.95 [0.39], P < .02). A significantly greater proportion of patients achieved remission in the MMB plus UDC group compared with the UDC only group (PHQ-9 score, <5: β [SE], 0.38 [0.14], P = .008), and rates of depressive relapse were significantly lower in the MMB plus UDC group compared with the UDC only group (hazard ratio, 0.61; 95% CI, 0.39-0.95; P < .03). Compared with the UDC only group, the MMB plus UDC group had decreased depression-free days (mean [SD], 281.14 [164.99] days vs 247.54 [158.32] days; difference, -33.60 [154.14] days; t = -2.33; P = .02), decreased anxiety (mean [SE] General Anxiety Disorder-7 Item Scale score, 1.21 [0.42], P = .004), and improved mental functioning (mean [SE] 12-Item Short Form Survey score, -5.10 [1.37], P < .001), but there was no statistically significant difference in physical functioning.

CONCLUSIONS AND RELEVANCE

Use of MMB plus UDC resulted in significant improvement in depression and functional outcomes compared with UDC only. The MMB web-based treatment may offer a scalable approach for the management of residual depressive symptoms.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT02190968.

摘要

重要性

患有残留抑郁症状的患者面临着护理缺口,因为迄今为止,几乎没有资源可以管理他们疾病的持续影响。

目的

评估使用基于正念的认知疗法(Mindful Mood Balance,MMB)治疗残留抑郁症状的有效性,这种基于网络的应用程序还提供常规的抑郁症护理,与仅接受常规抑郁症护理相比。

设计、地点和参与者:这是一项在科罗拉多州丹佛市 Kaiser Permanente 的初级保健和行为健康诊所进行的随机临床试验。招募了被诊断为有残留抑郁症状的成年人,招募时间为 2015 年 3 月 2 日至 2018 年 11 月 30 日。对参与者进行了 15 个月的评估,包括 3 个月的干预期和 12 个月的随访期。

干预措施

患者被随机分配接受常规抑郁症护理(UDC;n=230)或 MMB 加 UDC(n=230),其中包括 8 次在线治疗,为期 3 个月,外加最少的电话或电子邮件辅导支持。

主要结果和测量

主要结果是残留抑郁症状严重程度的减少,使用患者健康问卷-9(PHQ-9)评估;抑郁复发的比率(PHQ-9 评分≥15);以及缓解的比率(PHQ-9 评分<5)。次要结果包括无抑郁天数、焦虑症状(广泛性焦虑障碍-7 项量表)和功能状态(12 项简短健康调查)。

结果

在 460 名随机参与者中(平均[SD]年龄,48.30[14.89]岁;346 名女性[75.6%]),对意向治疗样本进行了数据分析,其中 362 名参与者(78.7%)在 3 个月时和 330 名参与者(71.7%)在 15 个月时进行了分析。与仅接受 UDC 的参与者相比,接受 MMB 加 UDC 的参与者的残留抑郁症状显著减轻(平均[SE]PHQ-9 评分,0.95[0.39],P<.02)。与仅接受 UDC 的参与者相比,MMB 加 UDC 组中达到缓解的患者比例显著更高(PHQ-9 评分<5:β[SE],0.38[0.14],P=.008),且 MMB 加 UDC 组的抑郁复发率显著更低(危险比,0.61;95%CI,0.39-0.95;P<.03)。与仅接受 UDC 的参与者相比,MMB 加 UDC 组的无抑郁天数减少(平均[SD],281.14[164.99]天 vs 247.54[158.32]天;差值,-33.60[154.14]天;t=-2.33;P=.02),焦虑症状减少(平均[SE]广泛性焦虑障碍-7 项量表评分,1.21[0.42],P=.004),心理健康功能改善(平均[SE]12 项简短健康调查评分,-5.10[1.37],P<.001),但在身体功能方面没有统计学上的显著差异。

结论和相关性

与仅接受 UDC 相比,使用 MMB 加 UDC 可显著改善抑郁和功能结果。基于网络的 MMB 治疗方法可能为管理残留抑郁症状提供一种可扩展的方法。

试验注册

ClinicalTrials.gov 标识符:NCT02190968。

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