Quadt Lisa, Garfinkel Sarah N, Mulcahy James S, Larsson Dennis Eo, Silva Marta, Jones Anna-Marie, Strauss Clara, Critchley Hugo D
Department of Neuroscience, Brighton and Sussex Medical School,Trafford Centre, University of Sussex Brighton, United Kingdom.
Sussex Partnership NHS Foundation Trust Brighton, United Kingdom.
EClinicalMedicine. 2021 Aug 1;39:101042. doi: 10.1016/j.eclinm.2021.101042. eCollection 2021 Sep.
This trial tested if a novel therapy, Aligning Dimensions of Interoceptive Experience (ADIE), reduces anxiety in autistic adults. ADIE targets the association of anxiety with mismatch between subjective and behavioral measures of an individual's ve to bodily signals, including heartbeats.
In this superiority randomized controlled trial, autistic adults (18-65 years) from clinical and community settings in Southern England were randomly assigned (1:1) to receive six sessions of ADIE or an active 'exteroceptive' control therapy (emotional prosody identification). Researchers conducting outcome assessments were blind to allocation. ADIE combines two modified heartbeat detection tasks with performance feedback and physical activity manipulation that transiently increases cardiac arousal. Participants were followed-up one-week (T1) and 3-months post-intervention (T2). The primary outcome was Spielberger Trait Anxiety Score (STAI-T) at T2. Outcomes were assessed on an intention-to-treat basis using multiple imputation for dealing with missing values. This trial was registered at International Standard Randomized Controlled Trial Registry, ISRCTN14848787.
Between July 01, 2017, and December 31, 2019, 121 participants were randomly allocated to ADIE ( = 61) or prosody ( = 60) intervention groups. Data at T1 was provided by 85 (70%) participants (46 [75%] ADIE; 39 [65%] prosody). Data at T2 was provided by 61 (50%) participants (36 [59%] ADIE; 25 [42%] prosody). One adverse event (cardiac anxiety following ADIE) was recorded. A statistically significant group effect of ADIE on trait anxiety continued at T2 (estimated mean difference 3•23 [95% CI 1•13 to 5•29]; = 0•30 [95% CI 0•09 to 0•51]; = 0•005) with 31% of ADIE group participants meeting trial criteria for recovery (compared to 16% in the control group).
ADIE can reduce anxiety in autistic adults, putatively improving regulatory control over internal stimuli. With little reliance on language and emotional insight, ADIE may constitute an inclusive intervention.
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本试验旨在检验一种新型疗法——内感受体验维度调整疗法（ADIE）是否能减轻成年自闭症患者的焦虑。ADIE旨在解决焦虑与个体对身体信号（包括心跳）的主观和行为测量之间的不匹配问题。
在这项优效性随机对照试验中，来自英格兰南部临床和社区环境的18至65岁成年自闭症患者被随机分配（1:1）接受六次ADIE治疗或积极的“外感受性”对照疗法（情绪韵律识别）。进行结果评估的研究人员对分组情况不知情。ADIE将两项改良的心跳检测任务与表现反馈及身体活动操作相结合，短暂增加心脏唤醒。干预后1周（T1）和3个月（T2）对参与者进行随访。主要结局是T2时的斯皮尔伯格特质焦虑评分（STAI-T）。采用多重填补法处理缺失值，基于意向性分析评估结果。本试验已在国际标准随机对照试验注册库注册，注册号为ISRCTN14848787。
在2017年7月1日至2019年12月31日期间，121名参与者被随机分配到ADIE组（n = 61）或韵律组（n = 60）。85名（70%）参与者提供了T1数据（46名[75%]ADIE组；39名[65%]韵律组）。61名（50%）参与者提供了T2数据（36名[59%]ADIE组；25名[42%]韵律组）。记录到1例不良事件（ADIE治疗后出现心脏焦虑）。ADIE对特质焦虑的组效应在T2时仍具有统计学意义（估计平均差异为3.23[95%CI 1.13至5.29]；Cohen's d = 0.30[95%CI 0.09至0.51]；p = 0.005），ADIE组31%的参与者达到试验恢复标准（对照组为16%）。
ADIE可减轻成年自闭症患者的焦虑，可能改善对内部刺激的调节控制。由于对语言和情感洞察力依赖较小，ADIE可能构成一种包容性干预措施。
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