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通过网络应用程序提供的认知行为疗法对阈下抑郁、阈下失眠和阈下惊恐的疗效:开放标签6臂随机临床试验初步研究。

Effectiveness of Cognitive Behavioral Therapy Provided Through a Web Application for Subthreshold Depression, Subthreshold Insomnia, and Subthreshold Panic: Open-Labeled 6-Arm Randomized Clinical Trial Pilot Study.

作者信息

Taguchi Kayoko, Miyoshi Mirai, Seki Yoichi, Baba Shiori, Shimizu Eiji

机构信息

Research Center for Child Mental Development, Chiba University, Chiba, Japan.

Graduate School of Medicine, Chiba University, Chiba, Japan.

出版信息

JMIR Form Res. 2025 Feb 3;9:e63139. doi: 10.2196/63139.

Abstract

BACKGROUND

A common definition of "subthreshold" is that the diagnostic threshold is not met but the individuals are not asymptomatic. Some symptoms are present, causing significant difficulty in functioning and negatively impacting quality of life. Despite the attention given to subthreshold symptoms and the interventions for subthreshold symptoms being efficient in preventing the transition to psychiatric disease in primary care, reports on specific interventions are insufficient.

OBJECTIVE

This study aimed to verify the effectiveness of internet-delivered cognitive behavioral therapy (ICBT) for subthreshold depression (SD), subthreshold insomnia (SI), and subthreshold panic (SP). Additionally, this study aimed to explore the minimally important change (MIC) of each subthreshold group's effectiveness outcome.

METHODS

Participants aged 18-70 years from internet research monitors were categorized into SD, SI, and SP groups based on screening assessment. They were randomly assigned to intervention or control groups within each subthreshold symptom. The intervention groups worked on 4 weeks of nonguided ICBT ("Mentre"), while the control groups worked on a sham app. The primary outcome was the score change from screening (T1) to 4-week follow-up (T4) using the Center for Epidemiologic Studies Depression Scale (CESD) in the SD group, the Pittsburgh Sleep Quality Index (PSQI) in the SI group, and the Panic and Agoraphobia Scale (PAS) in the SP group. Secondary outcomes were score changes in the Generalized Anxiety Disorder-7 (GAD-7) scale, the Patient Health Questionnaire 9 (PHQ-9), the CESD, the PSQI, and the PAS, except the primary outcome in each group. Secondary outcomes were analyzed using complete-case analysis and repeated-measures ANOVA. Additionally, the MIC in the primary endpoint for each group was also calculated as an exploratory outcome.

RESULTS

The SD, SP, and SI groups contained 846, 597, and 1106 participants, respectively. In the SD group, the difference in the CESD score change from baseline to follow-up between the intervention and control groups was significant (difference=0.52, 95% CI 1.29-4.66, P<.001). In the SI group, the difference in the PSQI score change was also significant (difference=0.53, 95% CI 0.11-0.94, P=.01). However, in the SP group, the difference in the PAS score change was not significant (difference=0.07, 95% CI -2.00 to 2.15, P=.94).

CONCLUSIONS

Our ICBT program Mentre contributes to the improvement of SI and SD. This suggests that nonguided ICBT may be effective in preventing SI and SD from progressing to the full threshold. However, appropriate definitions of subthreshold symptoms are necessary. In particular, it is difficult to define SP, and further research that considers the specific factors of each subthreshold symptom is necessary to accumulate evidence.

TRIAL REGISTRATION

University Hospital Medical Information Network (UMIN) UMIN000051280; https://tinyurl.com/2wyahhe3.

摘要

背景

“阈下症状”的一个常见定义是未达到诊断阈值,但个体并非无症状。存在一些症状,导致功能出现显著困难并对生活质量产生负面影响。尽管阈下症状受到了关注,且在初级保健中针对阈下症状的干预措施在预防向精神疾病转变方面是有效的,但关于具体干预措施的报告并不充分。

目的

本研究旨在验证互联网认知行为疗法(ICBT)对阈下抑郁(SD)、阈下失眠(SI)和阈下惊恐(SP)的有效性。此外,本研究旨在探索每个阈下组有效性结果的最小重要变化(MIC)。

方法

来自互联网研究监测机构的18 - 70岁参与者根据筛查评估被分为SD、SI和SP组。在每个阈下症状组内,他们被随机分配到干预组或对照组。干预组进行为期4周的无指导ICBT(“Mentre”),而对照组使用一个虚假应用程序。主要结局是SD组使用流行病学研究中心抑郁量表(CESD)、SI组使用匹兹堡睡眠质量指数(PSQI)、SP组使用惊恐和广场恐惧症量表(PAS)从筛查(T1)到4周随访(T4)的得分变化。次要结局是除每组主要结局外,广泛性焦虑障碍7项量表(GAD - 7)、患者健康问卷9项(PHQ - 9)、CESD、PSQI和PAS的得分变化。次要结局使用完全病例分析和重复测量方差分析进行分析。此外,还计算了每组主要终点的MIC作为探索性结局。

结果

SD组、SP组和SI组分别包含846名、597名和1106名参与者。在SD组中,干预组与对照组从基线到随访的CESD得分变化差异显著(差异 = 0.52,95%置信区间1.29 - 4.66,P <.001)。在SI组中,PSQI得分变化差异也显著(差异 = 0.53,95%置信区间0.11 - 0.94,P =.01)。然而,在SP组中,PAS得分变化差异不显著(差异 = 0.07,95%置信区间 - 2.00至2.15,P =.94)。

结论

我们的ICBT项目Mentre有助于改善SI和SD。这表明无指导的ICBT可能有效地防止SI和SD发展到完全阈值状态。然而,需要对阈下症状进行恰当定义。特别是,难以定义SP,有必要进行进一步研究,考虑每个阈下症状的具体因素以积累证据。

试验注册

大学医院医学信息网络(UMIN)UMIN000051280;https://tinyurl.com/2wyahhe3

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1a36/11833268/4157fb8f6df5/formative_v9i1e63139_fig1.jpg

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