Department of Psychology, National University of Singapore, Singapore, Singapore.
Department of Health Policy, Harvard Medical School, Boston, MA, United States.
JMIR Ment Health. 2024 Apr 19;11:e53712. doi: 10.2196/53712.
BACKGROUND: Theories propose that brief, mobile, self-guided mindfulness ecological momentary interventions (MEMIs) could enhance emotion regulation (ER) and self-compassion. Such changes are posited to be mechanisms of change. However, rigorous tests of these theories have not been conducted. 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. TRIAL REGISTRATION: Open Science Framework (OSF) Registries; osf.io/m3kxz https://osf.io/m3kxz.
背景：理论提出，简短、移动、自我引导的正念生态瞬间干预（MEMI）可以增强情绪调节（ER）和自我同情。这些变化被认为是改变的机制。然而，这些理论并没有经过严格的测试。
目的：在这项评估者盲法、平行组随机对照试验中，我们旨在在社交焦虑障碍（SAD）中测试这些理论。
方法：患有 SAD（定义为在随机分组前的自我报告中社交恐惧症量表的得分≥20）的参与者被随机分配到为期 14 天的完全自我引导的 MEMI（96/191，50.3%）或自我监测应用程序（95/191，49.7%）组。他们在随机分组前、15 天干预后（在干预结束后的第二天进行）和 1 个月随访时间点完成了 6 项临床结果测量的在线自我报告。在干预前和 7 天中期评估 ER 和自我同情。多层次模型确定了 MEMI 对 ER 和自我同情领域的疗效，从 pretrial到中期干预时间点。Bootstrapped 平行多层次中介分析检验了从 Pretrial 到中期干预的 ER 和自我同情领域对 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依从性，78%（191 人中有 149 人）至少完成了 80%的 MEMI 和自我监测提示。与自我监测应用程序相比，MEMI 更有效地降低了 ER 目标导向行为困难（组间 Cohen d=-0.24）和缺乏情绪清晰度（Cohen d=0.16），并增加了自我同情的社会联系（Cohen d=0.19），非情感认同（Cohen d=0.16）和自我善良（Cohen d=0.19），从 Pretrial 到中期干预时间点。在 MEMI 臂中，从 Pretrial 到中期干预的组内效应大小大于自我监测应用程序臂（ER 目标导向行为困难：Cohen d=-0.73 对 -0.29，缺乏情绪清晰度：Cohen d=-0.39 对 -0.21，自我同情的社会联系领域：Cohen d=0.45 对 0.19，非情感认同：Cohen d=0.63 对 0.48，自我善良：Cohen d=0.36 对 0.10）。自我监测，而不是 MEMI，减轻了 ER 情绪意识问题（组间 Cohen d=0.11，组内 Cohen d=-0.29 对 -0.13），并减少了自我同情承认共同的人类挣扎（组间 Cohen d=0.26，组内 Cohen d=-0.23 对 0.13）。没有 ER 和自我同情领域是 MEMI 对 SAD 症状（P=0.07-<0.99）、广泛性焦虑症状（P=0.16-0.98）、抑郁严重程度（P=0.20-0.94）、重复消极思维（P=0.12-0.96）和特质正念（P=0.18-0.99）从 Pretrial 到 postintervention 时间点的中介作用。从 Pretrial 到 1 个月随访时间点，所有这些临床结果都出现了类似的非显著中介效应（P=0.11-0.98）。
结论：简短、完全自我引导的移动 MEMI 有效地增加了特定的自我同情领域，并从 Pretrial 到中期干预时间点降低了与目标追求和情绪清晰度相关的 ER 困难。需要更高强度的 MEMI 来确定 SAD 中 ER 和自我同情领域的特定变化机制。
试验注册：开放科学框架（OSF）注册表；osf.io/m3kxz https://osf.io/m3kxz。
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