OBJECTIVE: In this assessor-blinded, parallel-group randomized controlled trial, we aimed to test these theories in social anxiety disorder (SAD).
METHODS: Participants with SAD (defined as having a prerandomization cut-off score ≥20 on the Social Phobia Inventory self-report) were randomized to a 14-day fully self-guided MEMI (96/191, 50.3%) or self-monitoring app (95/191, 49.7%) arm. They completed web-based self-reports of 6 clinical outcome measures at prerandomization, 15-day postintervention (administered the day after the intervention ended), and 1-month follow-up time points. ER and self-compassion were assessed at preintervention and 7-day midintervention time points. Multilevel modeling determined the efficacy of MEMI on ER and self-compassion domains from pretrial to midintervention time points. Bootstrapped parallel multilevel mediation analysis examined the mediating role of pretrial to midintervention ER and self-compassion domains on the efficacy of MEMI on 6 clinical outcomes.
RESULTS: Participants demonstrated strong compliance, with 78% (149/191) engaging in at least 80% of the MEMI and self-monitoring prompts. MEMI was more efficacious than the self-monitoring app in decreasing ER goal-directed behavior difficulties (between-group Cohen d=-0.24) and lack of emotional clarity (Cohen d=0.16) and increasing self-compassion social connectedness (Cohen d=0.19), nonidentification with emotions (Cohen d=0.16), and self-kindness (Cohen d=0.19) from pretrial to midintervention time points. The within-group effect sizes from pretrial to midintervention were larger in the MEMI arm than in the self-monitoring app arm (ER goal-directed behavior difficulties: Cohen d=-0.73 vs -0.29, lack of emotional clarity: Cohen d=-0.39 vs -0.21, self-compassion domains of social connectedness: Cohen d=0.45 vs 0.19, nonidentification with emotions: Cohen d=0.63 vs 0.48, and self-kindness: Cohen d=0.36 vs 0.10). Self-monitoring, but not MEMI, alleviated ER emotional awareness issues (between-group Cohen d=0.11 and within-group: Cohen d=-0.29 vs -0.13) and reduced self-compassion acknowledging shared human struggles (between-group Cohen d=0.26 and within-group: Cohen d=-0.23 vs 0.13). No ER and self-compassion domains were mediators of the effect of MEMI on SAD symptoms (P=.07-<.99), generalized anxiety symptoms (P=.16-.98), depression severity (P=.20-.94), repetitive negative thinking (P=.12-.96), and trait mindfulness (P=.18-.99) from pretrial to postintervention time points. Similar nonsignificant mediation effects emerged for all of these clinical outcomes from pretrial to 1-month follow-up time points (P=.11-.98).
CONCLUSIONS: Brief, fully self-guided, mobile MEMIs efficaciously increased specific self-compassion domains and decreased ER difficulties associated with goal pursuit and clarity of emotions from pretrial to midintervention time points. Higher-intensity MEMIs may be required to pinpoint the specific change mechanisms in ER and self-compassion domains of SAD.
BACKGROUND: Open Science Framework (OSF) Registries; osf.io/m3kxz https://osf.io/m3kxz.
目的:在本评估方盲中,平行组随机对照试验,我们的目的是在社交焦虑障碍(SAD)中测试这些理论。
方法:患有SAD(定义为在社交恐惧症清单自我报告中具有≥20的预随机截止分数)的参与者被随机分配到14天完全自我指导的MEMI(96/191,50.3%)或自我监控应用程序(95/191,49.7%)。他们在随机化前完成了6项临床结局指标的基于网络的自我报告,干预后15天(干预结束后的第二天进行),和1个月的随访时间点。在干预前和干预7天中期时间点评估ER和自我同情心。多水平建模确定了MEMI对ER和自我同情领域的功效,从审前到中间干预时间点。自举并行多水平调解分析检查了审前对中期干预ER和自我同情域对MEMI对6项临床结果的疗效的中介作用。
结果:参与者表现出很强的合规性,78%(149/191)参与至少80%的MEMI和自我监测提示。MEMI在减少ER目标导向行为困难(组间科恩d=-0.24)和缺乏情绪清晰度(科恩d=0.16)以及增加自我同情社会联系(科恩d=0.19)方面比自我监控应用程序更有效。不认同情绪(科恩d=0.16),和自我善良(科恩d=0.19)从预审到中期干预时间点。从审前到中期干预,MEMI组的组内效应大小大于自我监控应用程序组(ER目标导向的行为困难:Cohend=-0.73vs-0.29,缺乏情绪清晰度:Cohend=-0.39vs-0.21,社会联系的自我同情领域:Cohend=0.45vs0.19,对情绪的非认同:Cohend=0.63vs0.48,自我=0.48)。自我监控,但不是MEMI,缓解了ER情绪意识问题(组之间的Cohend=0.11和组内:Cohend=-0.29vs-0.13),并减少了对人类共同斗争的自我同情(组间Cohend=0.26和组内:Cohend=-0.23vs0.13)。没有ER和自我同情域是MEMI对SAD症状影响的媒介(P=.07-<.99),广泛性焦虑症状(P=.16-.98),抑郁严重程度(P=.20-.94),重复性消极思维(P=.12-.96),和特质正念(P=0.18-.99)从审判前到干预后的时间点。从试验前到1个月随访时间点,所有这些临床结果都出现了类似的无意义的中介效应(P=.11-.98)。
结论:简介,完全自我引导,移动MEMI有效地增加了特定的自我同情领域,并减少了与目标追求和从审前到介入中间时间点的情绪清晰度相关的ER困难.可能需要更高强度的MEMI来查明SAD的ER和自我同情领域的特定变化机制。
背景:开放科学框架(OSF)注册中心;osf.io/m3kxzhttps://osf.io/m3kxz。