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Woebot Health宣布首例随机对照试验将Woebot与临床医生指导的心理疗法进行比较,结果表明数字心理健康干预在减轻青少年抑郁症状方面并无劣势

First Randomized Controlled Trial Comparing Woebot to Clinician-Led Psychotherapy Reveals Digital Mental Health Intervention Is Non-Inferior in Reducing Depressive Symptoms Among Teens

businesswire 等信源发布 2023-10-26 23:00

可切换为仅中文


NEW YORK--(BUSINESS WIRE)--Woebot Health today announced positive results from a study at Children’s Hospital of The King’s Daughters (CHKD) showing that the digital mental health intervention W-GenZD, a Woebot-based study app, led to reductions in depressive symptoms that were non-inferior to those achieved by a clinician-led telehealth Cognitive Behavioral Therapy (CBT) skills group.

纽约-(商业信息)-Woebot Health今天宣布在国王女儿儿童医院(CHKD)进行的一项研究取得了积极成果,该研究表明,基于Woebot的数字心理健康干预W-GenZD研究应用程序减少了抑郁症状,这些症状不逊于临床医生主导的远程医疗认知行为疗法(CBT)技能组所达到的症状。

Participants in both the W-GenZD and telehealth groups reported a significant reduction in depressive symptoms (PHQ-8) from baseline to end of treatment (week 4) and had similar levels of intervention feasibility and satisfaction. The results were presented in a poster presentation at the American Academy of Child and Adolescent Psychiatry (AACAP) conference..

W-GenZD和远程医疗组的参与者报告抑郁症状(PHQ-8)从基线到治疗结束(第4周)显着减少,并且具有相似的干预可行性和满意度。结果在美国儿童和青少年精神病学会(AACAP)会议上的海报展示中呈现。。

This is the first known study to compare an agent-based digital mental health intervention to a therapist-led therapeutic intervention in a real-world clinical setting. It included multiple methods of safety monitoring of adolescents in both interventions. There were no serious adverse events in either group and no unanticipated adverse device effects in the W-GenZD group.

这是第一个将基于代理的数字心理健康干预与现实世界临床环境中治疗师主导的治疗干预进行比较的已知研究。它包括两种干预措施中青少年安全监测的多种方法。两组均无严重不良事件发生,W-GenZD组无意外不良器械效应。

The findings suggest a potential role for W-GenZD within outpatient mental health care clinics to address the ongoing adolescent mental health crisis..

研究结果表明W-GenZD在门诊精神卫生保健诊所中可能发挥作用,以解决正在进行的青少年心理健康危机。。

The study was conducted by Woebot Health in collaboration with CHKD, a hospital and outpatient mental health clinic that uses a stepped care approach to triage patients depending on their presenting level of need. The 141 teen participants were actively seeking outpatient mental health services for symptoms of depression and/or anxiety and represented a mix of identities (92% non-Hispanic, 49% White, 34% African American and 60% heterosexual).

这项研究是由Woebot Health与CHKD合作进行的,CHKD是一家医院和门诊精神卫生诊所,根据患者的需求水平采用分阶段护理方法对患者进行分类。这141名青少年参与者正在积极寻求门诊心理健康服务以治疗抑郁和/或焦虑症状,并代表了多种身份(92%非西班牙裔,49%白人,34%非裔美国人和60%异性恋)。

The study was designed to investigate the feasibility, satisfaction and non-inferiority (for PHQ-8) of W-GenZD (n = 71) compared to a group receiving CBT skills delivered via telehealth and led by a licensed mental health clinician (n = 70)..

该研究旨在调查W-GenZD(n=71)的可行性,满意度和非劣效性(对于PHQ-8),与通过远程医疗提供CBT技能并由获得许可的心理健康临床医生领导的组相比(n=70)。。

Importantly, both groups developed similar levels of therapeutic working alliance, meaning perceived alliance between the teen and the human group leader or between the teen and Woebot. Therapeutic alliance measures the relationship between provider and patient/participant, with research indicating that it is an important predictor of therapeutic outcomes.

重要的是,两组都建立了相似水平的治疗工作联盟,这意味着青少年与人类领导者之间或青少年与Woebot之间的感知联盟。治疗联盟测量提供者和患者/参与者之间的关系,研究表明它是治疗结果的重要预测因子。

Previous research from Woebot Health has found that people reported formation of a therapeutic bond similar to the bond formed with human therapists in other studies..

Woebot Health先前的研究发现,人们报告了一种治疗性键的形成,类似于其他研究中与人类治疗师形成的键。。

The pandemic exacerbated a long-standing crisis of unmet pediatric mental health needs into a national state of emergency, prompting President Biden to highlight youth mental health as a priority in his 2023 State of the Union address and the Biden-Harris Administration to more recently provide more than $200 million in funding to expand youth mental health care services.

这一流行病加剧了长期以来儿童心理健康需求未得到满足的危机进入国家紧急状态,促使拜登总统强调青年心理健康是其2023年的工会地址和拜登哈里斯政府最近提供的优先事项。超过2亿美元的资金用于扩大青年心理保健服务。

Even before the skyrocketing demand for mental health services, CHKD had embarked on a major expansion of its team and services, including state-of-the-art preventive, outpatient and inpatient services in a new mental health facility..

甚至在精神卫生服务需求飙升之前,CHKD就开始了其团队和服务的大幅扩展,包括在新的精神卫生机构中提供最先进的预防,门诊和住院服务。。

“The unprecedented need for child mental health services, along with a national shortage of pediatric mental health providers, requires us to look for innovative approaches to provide support,” said Mary Margaret Gleason, MD, Vice Chair of Pediatrics at CHKD and Kay W. Abiouness Distinguished Professor at Eastern Virginia Medical School, and principal investigator of the study.

CHKD和Kay W.Abiouness儿科副主席Mary Margaret Gleason博士说:“对儿童心理健康服务的前所未有的需求,以及全国儿科心理健康服务提供者的短缺,要求我们寻找创新的方法来提供支持。”东弗吉尼亚医学院杰出教授兼该研究首席研究员。

“This study offered us a chance to examine a novel intervention that could help address adolescent anxiety and depression on their own schedule, in a familiar, digital environment. The positive findings indicate that high-quality, rigorously studied mobile health apps can be considered as part of our toolkit to address the child mental health crisis.”.

“这项研究为我们提供了一个机会,在熟悉的数字环境中,在自己的时间表上检查一种可以帮助解决青少年焦虑和抑郁的新型干预措施。积极的研究结果表明,高质量,经过严格研究的移动健康应用程序可以被视为我们解决儿童心理健康危机工具包的一部分“。

One of the study participants confirmed the most helpful aspect of W-GenZD was its accessibility. “If I needed help immediately, I could get it. I think just knowing I had someone or something there to help me out reduced some of my anxiety.”

其中一名研究参与者证实W-GenZD最有用的方面是它的可及性。“如果我立即需要帮助,我就可以得到它,我想知道我有人或别的东西可以帮助我减少一些焦虑。”

Woebot Health’s Chief Clinical Officer Athena Robinson, PhD, added, “This is a transformational time for evidence-based, technology-supported care, and it has been rewarding to work with an organization interested in evaluating new approaches to expand services for teens in need. We look forward to additional collaborations that examine and showcase technology’s potential to set a new framework for care.”.

Woebot Health的首席临床官Athena Robinson博士补充说,“这是一个以证据为基础,技术支持的护理的转型时期,与一个有兴趣评估扩展青少年服务的新方法的组织合作是有益的。我们期待着额外的合作来检查和展示技术为护理设定新框架的潜力“。

Study design and methodology

研究设计和方法

Between May 2022 and February 2023, after a clinical visit to the CHKD facilities, participants were triaged into standard outpatient mental health care and were screened and randomized to W-GenZD or a CBT Skills Group. Assessments were at baseline, 4 weeks end of treatment and 8-weeks end-of-study and included: a Patient Health Questionnaire (PHQ-8) assessing depression symptoms; a Generalized Anxiety Disorder (GAD-7) score assessing anxiety symptoms; a Working Alliance Inventory–Short Form (WAI-SR) score; a Usage Rating Profile–Intervention Revised (URP-IR) score for feasibility; and a Client Satisfaction Questionnaire (CSQ-8) satisfaction rating.

在2022年5月至2023年2月之间,在对CHKD设施进行临床访问后,将参与者分为标准门诊精神卫生保健部门,并进行筛查并随机分配到W-GenZD或CBT技能小组。评估在基线,治疗结束4周和研究结束8周,包括:评估抑郁症状的患者健康问卷(PHQ-8);评估焦虑症状的广泛性焦虑症(GAD-7)评分;工作联盟库存-简表(WAI-SR)评分;使用评级概况-干预修订(URP-IR)评分的可行性;和客户满意度问卷(CSQ-8)满意度评分。

A non-inferiority test was used to evaluate the study aim comparing the reduction in PHQ-8-measured depression symptoms between the two interventions at the end of treatment. Clinical trial information is available at https://clinicaltrials.gov/study/NCT05372913..

使用非劣效性测试来评估研究目的,比较治疗结束时两种干预措施之间PHQ-8测量的抑郁症状的减少。临床试验信息可在https://clinicaltrials.gov/study/NCT05372913..

About Woebot Health

关于Woebot健康

Woebot Health is the mental health ally for people and businesses that is answering the skyrocketing need for mental health care by breaking down the systemic constraints that block equal access to it. Our relational agent, Woebot, is at the heart of a powerful platform that can tailor products for specific intended uses and patient populations.

Woebot Health是人类和企业的心理健康盟友,它通过打破阻碍平等访问的系统性约束来满足对心理健康护理急剧增长的需求。我们的关系代理Woebot是一个强大平台的核心,可以为特定的预期用途和患者人群量身定制产品。

It’s also the foundation of our solutions, which offer CBT-based support tools for adults, adolescents and new mothers. We work directly with virtual primary care companies, payers and IDNs to put scalable and validated mental health solutions directly in the hands of those who need them. For more information, visit woebothealth.com.

这也是我们解决方案的基础,为成人,青少年和新妈妈提供基于CBT的支持工具。我们直接与虚拟初级保健公司,付款人和IDN合作,将可扩展和经过验证的心理健康解决方案直接交给需要他们的人。欲了解更多信息,请访问woebothealth.com。

W-GenZD is not evaluated, cleared or approved by the FDA. It may be considered as an adjunct to clinical care. It does not replace clinical care.

W-GenZD未经FDA评估,批准或批准。它可以被认为是临床护理的辅助手段。它不能取代临床护理。