Chiauzzi Emil, Robinson Athena, Martin Kate, Petersen Carl, Wells Nicole, Williams Andre, Gleason Mary Margaret
Woebot Health, San Francisco, CA, United States.
Children's Hospital of The King's Daughters, Norfolk, VA, United States.
JMIR Res Protoc. 2023 Mar 3;12:e44940. doi: 10.2196/44940.
Unmet pediatric mental health (MH) needs are growing as rates of pediatric depression and anxiety dramatically increase. Access to care is limited by multiple factors, including a shortage of clinicians trained in developmentally specific, evidence-based services. Novel approaches to MH care delivery, including technology-leveraged and readily accessible options, need to be evaluated in service of expanding evidence-based services to youths and their families. Preliminary evidence supports the use of Woebot, a relational agent that digitally delivers guided cognitive behavioral therapy (CBT) through a mobile app, for adults with MH concerns. However, no studies have evaluated the feasibility and acceptability of such app-delivered relational agents specifically for adolescents with depression and/or anxiety within an outpatient MH clinic, nor compared them to other MH support services.
This paper describes the protocol for a randomized controlled trial evaluating the feasibility and acceptability of an investigational device, Woebot for Adolescents (W-GenZD), within an outpatient MH clinic for youths presenting with depression and/or anxiety. The study's secondary aim will compare the clinical outcomes of self-reported depressive symptoms with W-GenZD and a telehealth-delivered CBT-based skills group (CBT-group). Tertiary aims will evaluate additional clinical outcomes and therapeutic alliance between adolescents in W-GenZD and the CBT-group.
Participants include youths aged 13-17 years with depression and/or anxiety seeking care from an outpatient MH clinic at a children's hospital. Eligible youths will have no recent safety concerns or complex comorbid clinical diagnoses; have no concurrent individual therapy; and, if on medications, are on stable doses, based on clinical screening and as well as study-specific criteria.
Recruitment began in May 2022. As of December 8, 2022, we have randomized 133 participants.
Establishing the feasibility and acceptability of W-GenZD within an outpatient MH clinical setting will add to the field's current understanding of the utility and implementation considerations of this MH care service modality. The study will also evaluate the noninferiority of W-GenZD against the CBT-group. Findings may also have implications for patients, families, and providers looking for additional MH support options for adolescents seeking help for their depression and/or anxiety. Such options expand the menu of supports for youths with lower-intensity needs as well as possibly reduce waitlists and optimize clinician deployment toward more severe cases.
ClinicalTrials.gov NCT05372913; https://clinicaltrials.gov/ct2/show/NCT05372913.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44940.
随着儿童抑郁症和焦虑症发病率急剧上升，未得到满足的儿童心理健康需求不断增加。获得护理受到多种因素限制，包括缺乏接受针对特定发育阶段的循证服务培训的临床医生。需要评估心理健康护理提供的新方法，包括利用技术且易于获得的选项，以便为青少年及其家庭扩大循证服务。初步证据支持将Woebot（一种通过移动应用程序以数字方式提供指导性认知行为疗法（CBT）的关系代理）用于有心理健康问题的成年人。然而，尚无研究评估这种通过应用程序提供的关系代理在门诊心理健康诊所中专门针对患有抑郁症和/或焦虑症的青少年的可行性和可接受性，也未将其与其他心理健康支持服务进行比较。
本文描述了一项随机对照试验的方案，该试验评估了一种研究性设备——青少年版Woebot（W-GenZD）在一家门诊心理健康诊所中对于患有抑郁症和/或焦虑症的青少年的可行性和可接受性。该研究的次要目的是比较使用W-GenZD和通过远程医疗提供的基于CBT的技能小组（CBT组）自我报告的抑郁症状的临床结果。第三目的将评估W-GenZD组和CBT组青少年的其他临床结果以及治疗联盟情况。
参与者包括年龄在13至17岁之间、在一家儿童医院的门诊心理健康诊所寻求治疗的患有抑郁症和/或焦虑症的青少年。符合条件的青少年近期无安全问题或复杂的共病临床诊断；没有同时接受个体治疗；并且，如果正在服药，根据临床筛查以及研究特定标准，药物剂量稳定。
招募工作于2022年5月开始。截至2022年12月8日，我们已将133名参与者随机分组。
确定W-GenZD在门诊心理健康临床环境中的可行性和可接受性将增进该领域目前对这种心理健康护理服务模式的效用和实施考量的理解。该研究还将评估W-GenZD相对于CBT组的非劣效性。研究结果可能对为患有抑郁症和/或焦虑症寻求帮助的青少年寻找额外心理健康支持选项的患者、家庭和提供者也有影响。这些选项为需求强度较低的青少年扩大了支持范围，也可能减少等候名单，并使临床医生能够更合理地调配资源，以应对更严重的病例。
ClinicalTrials.gov NCT05372913；https://clinicaltrials.gov/ct2/show/NCT05372913。
国际注册报告标识符（IRRID）：DERR1-10.2196/44940。
