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在模拟成人样本中采用个性化实时唤醒检测与反馈的暴露疗法减轻社交焦虑症状:概念验证性随机对照试验。

Exposure Therapy With Personalized Real-Time Arousal Detection and Feedback to Alleviate Social Anxiety Symptoms in an Analogue Adult Sample: Pilot Proof-of-Concept Randomized Controlled Trial.

作者信息

Lin Xiangting Bernice, Lee Tih-Shih, Cheung Yin Bun, Ling Joanna, Poon Shi Hui, Lim Leslie, Zhang Hai Hong, Chin Zheng Yang, Wang Chuan Chu, Krishnan Ranga, Guan Cuntai

机构信息

Neuroscience and Behavioral Disorders Program, Duke University - National University of Singapore Medical School, Singapore, Singapore.

Singapore General Hospital, Singapore, Singapore.

出版信息

JMIR Ment Health. 2019 Jun 14;6(6):e13869. doi: 10.2196/13869.

Abstract

BACKGROUND

Exposure therapy is highly effective for social anxiety disorder. However, there is room for improvement.

OBJECTIVE

This is a first attempt to examine the feasibility of an arousal feedback-based exposure therapy to alleviate social anxiety symptoms in an analogue adult sample.

METHODS

A randomized, pilot, proof-of-concept trial was conducted to evaluate the acceptability, safety, and preliminary efficacy of our treatment program. Sessions were administered once a week for 4 weeks (1 hour each) to an analogue sample of 50 young adults who reported at least minimal social anxiety symptoms. Participants in both intervention and waitlist control groups completed assessments for social anxiety symptoms at the baseline, week 5, and week 10.

RESULTS

Most participants found the intervention acceptable (82.0%, 95% CI 69.0%-91.0%). Seven (14.9%, 95% CI 7.0%-28.0%) participants reported at least one mild adverse event over the course of study. No moderate or serious adverse events were reported. Participants in the intervention group demonstrated greater improvements on all outcome measures of public speaking anxiety from baseline to week 5 as compared to the waitlist control group (Cohen d=0.61-1.39). Effect size of the difference in mean change on the overall Liebowitz Social Anxiety Scale was small (Cohen d=0.13).

CONCLUSIONS

Our results indicated that it is worthwhile to proceed to a larger trial for our treatment program. This new medium of administration for exposure therapy may be feasible for treating a subset of social anxiety symptoms. Additional studies are warranted to explore its therapeutic mechanisms.

TRIAL REGISTRATION

ClinicalTrials.gov NCT02493010; https://clinicaltrials.gov/ct2/show/NCT02493010.

摘要

背景

暴露疗法对社交焦虑障碍非常有效。然而,仍有改进的空间。

目的

这是首次尝试检验基于唤醒反馈的暴露疗法在模拟成人样本中减轻社交焦虑症状的可行性。

方法

进行了一项随机、试点、概念验证试验,以评估我们治疗方案的可接受性、安全性和初步疗效。对50名报告至少有轻微社交焦虑症状的年轻成人模拟样本,每周进行一次治疗,共4周(每次1小时)。干预组和等待名单对照组的参与者在基线、第5周和第10周完成社交焦虑症状评估。

结果

大多数参与者认为干预是可接受的(82.0%,95%可信区间69.0%-91.0%)。7名(14.9%,95%可信区间7.0%-28.0%)参与者在研究过程中报告了至少一次轻度不良事件。未报告中度或重度不良事件。与等待名单对照组相比,干预组参与者在从基线到第5周的所有公开演讲焦虑结局指标上都有更大改善(Cohen d=0.61-1.39)。在总体利博维茨社交焦虑量表上,平均变化差异的效应量较小(Cohen d=0.13)。

结论

我们的结果表明,对我们的治疗方案进行更大规模的试验是值得的。这种暴露疗法的新给药方式可能对治疗一部分社交焦虑症状是可行的。需要进一步的研究来探索其治疗机制。

试验注册

ClinicalTrials.gov NCT02493010;https://clinicaltrials.gov/ct2/show/NCT02493010

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/361a/6594210/833acc58e31e/mental_v6i6e13869_fig1.jpg

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