Department of Psychiatry, Weill Cornell Medicine, New York, New York.
Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, New York.
JAMA Netw Open. 2024 Aug 1;7(8):e2428372. doi: 10.1001/jamanetworkopen.2024.28372.
Anxiety disorders are prevalent and undertreated among young adults. Digital mental health interventions for anxiety are promising but limited by a narrow range of therapeutic components and low user engagement.
To investigate the efficacy of and engagement with Maya, a scalable, self-guided, comprehensive mobile cognitive behavioral therapy (CBT) intervention with embedded engagement features, comparing the effects of 3 incentive conditions.
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial recruited young adults aged 18 to 25 years with anxiety disorders through online advertisements and outpatient psychiatry clinics at Weill Cornell Medicine. Enrollment was between June 16, 2021, and November 11, 2022. Data analysis was performed from December 21, 2022, to June 14, 2024.
Participants received a 6-week program of the intervention and were randomized to 1 of 3 different text message-based incentive conditions (gain-framed, loss-framed, or gain-social support).
The primary outcome was change in anxious symptoms from baseline to end of treatment, as measured by the Hamilton Anxiety Rating Scale (HAM-A). The Anxiety Sensitivity Index and the Leibowitz Social Anxiety Scale scores were secondary measures.
The sample consisted of 59 participants (mean [SD] age, 23.1 [1.9] years; 46 [78%] female; 22 [37%] Asian, 3 [5%] Black, 5 [8%] Hispanic or Latino, 1 [2%] American Indian or Alaska Native, 25 [42%] White, and 6 [10%] >1 race; 32 [54%] college-educated and 12 [20%] graduate or professional school-educated; mean [SD] baseline HAM-A score, 15.0 [6.5]). Anxiety, measured by HAM-A, decreased across conditions from baseline to end of the intervention (mean difference, -5.64; 95% CI, -7.23 to -4.05), and symptomatic improvement was maintained at the week 12 follow-up (baseline to follow-up mean difference, -5.67; 95% CI, -7.29 to -4.04). However, there was no evidence that change in anxiety differed by incentive condition (loss-framed vs gain-social support mean difference, -1.40; 95% CI, -4.72 to 1.93; gain-framed vs gain-social support mean difference, 1.38; 95% CI, -1.19 to 3.96). Secondary anxiety measures (Anxiety Sensitivity Index and Liebowitz Social Anxiety Scale scores) showed a similar pattern of improvement, with no evidence of differences between incentive conditions. Participants completed most of the 12 sessions (mean [SD], 10.8 [2.1]; 95% CI, 10.3-11.4), and User Mobile Application Rating Scale app quality ratings exceeded the published threshold for acceptability at all study visits. There was no evidence that either session completion or app quality ratings differed by incentive condition.
In this randomized clinical trial of an app-based intervention for anxiety, the primary hypothesis that improvement in anxiety would be greatest in the condition using gain of points plus social incentives was not supported; however, the results suggest that a CBT application incorporating a full suite of CBT skills and embedded user engagement features was efficacious in improving symptoms in young adults with anxiety disorders. Given these findings, digital interventions represent a promising step toward wider dissemination of high-quality, evidence-based interventions.
ClinicalTrials.gov Identifier: NCT05130281.
重要性：焦虑障碍在年轻人中普遍存在且治疗不足。数字心理健康干预措施对焦虑症有一定的疗效，但由于治疗成分有限和用户参与度低，其应用受到限制。
目的：研究 Maya 干预措施的疗效和参与度，Maya 是一种可扩展的、自我引导的、综合的移动认知行为疗法（CBT）干预措施，具有嵌入式参与功能，比较了 3 种激励条件的效果。
设计、设置和参与者：本随机临床试验通过网络广告和威尔康奈尔医学院的门诊精神病诊所招募了年龄在 18 至 25 岁之间患有焦虑症的年轻人。招募时间为 2021 年 6 月 16 日至 2022 年 11 月 11 日。数据分析时间为 2022 年 12 月 21 日至 2024 年 6 月 14 日。
干预措施：参与者接受了为期 6 周的干预计划，并随机分为 3 种不同的基于短信的激励条件（收益框架、损失框架或收益-社会支持）之一。
主要结果和措施：主要结果是从基线到治疗结束时焦虑症状的变化，用汉密尔顿焦虑量表（HAM-A）进行测量。焦虑敏感指数和利博维茨社交焦虑量表评分是次要测量指标。
结果：该样本包括 59 名参与者（平均[标准差]年龄 23.1[1.9]岁；46[78%]女性；22[37%]亚洲人，3[5%]黑人，5[8%]西班牙裔或拉丁裔，1[2%]美洲印第安人或阿拉斯加原住民，25[42%]白人，6[10%]>1 种族；32[54%]受过大学教育，12[20%]受过研究生或专业学校教育；平均[标准差]基线 HAM-A 评分 15.0[6.5]）。焦虑，用 HAM-A 测量，从基线到干预结束时在所有条件下均有下降（平均差异，-5.64；95%置信区间，-7.23 至-4.05），在 12 周随访时症状改善仍持续（基线到随访的平均差异，-5.67；95%置信区间，-7.29 至-4.04）。然而，没有证据表明焦虑的变化因激励条件而异（损失框架与收益-社会支持的平均差异，-1.40；95%置信区间，-4.72 至 1.93；收益框架与收益-社会支持的平均差异，1.38；95%置信区间，-1.19 至 3.96）。次要焦虑测量（焦虑敏感指数和利博维茨社交焦虑量表评分）也显示出类似的改善模式，没有证据表明激励条件之间存在差异。参与者完成了大部分 12 次疗程（平均[标准差]，10.8[2.1]；95%置信区间，10.3-11.4），用户移动应用评分量表的应用质量评分在所有研究访问中都超过了可接受性的公布阈值。没有证据表明疗程完成或应用质量评分因激励条件而异。
结论和相关性：在这项针对焦虑症的基于应用程序的干预措施的随机临床试验中，主要假设是在使用积分和社会激励的条件下，焦虑的改善程度最大，这一假设没有得到支持；然而，结果表明，包含全套 CBT 技能和嵌入式用户参与功能的 CBT 应用程序在改善年轻焦虑症患者的症状方面是有效的。鉴于这些发现，数字干预措施代表了朝着更广泛传播高质量、基于证据的干预措施迈出的有希望的一步。
试验注册：ClinicalTrials.gov 标识符：NCT05130281。
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