An Efficacy Trial of a Digital Therapeutic for Suicide Prevention
数字疗法预防自杀的功效试验
基本信息
- 批准号:10673941
- 负责人:
- 金额:$ 79.51万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2020
- 资助国家:美国
- 起止时间:2020-07-23 至 2024-07-31
- 项目状态:已结题
- 来源:
- 关键词:AccelerationAcuteAddressAdultAppointmentBehavioralCause of DeathCellular PhoneClinicalClinical TrialsCognitiveCognitive TherapyComplementCost SavingsDecision MakingDevelopmentDrug PrescriptionsEducational process of instructingEffectivenessEnrollmentEnsureEventExerciseFeasibility StudiesFeedbackFeeling suicidalFormulariesFutureGeneral PopulationGoalsGrantHealthHealth PersonnelHealth Services AccessibilityHomeHospitalizationInpatientsLettersLicensingMarketingMeasuresMediationMental DepressionMental Health ServicesMethodsModalityNational Institute of Mental HealthOutcomeOutpatientsParticipantPatientsPenetrationPersonsPharmacologic SubstancePhasePopulationPrevention ProtocolsPriceProviderPublic HealthQuestionnairesRandomized, Controlled TrialsRecording of previous eventsRelaxationRiskRisk ReductionSmall Business Innovation Research GrantSpecialistSuicideSuicide attemptSuicide preventionSurvival AnalysisSystemTestingTherapeuticTimeUnited States Substance Abuse and Mental Health Services AdministrationUpdateVisitWorkchatbotclinical research sitecommercial applicationcostcost estimatedigitaldigital treatmenteconomic costeffective therapyefficacy evaluationefficacy trialemotion regulationexperienceimprovedmobile applicationopen labelphase 1 studyphase 2 studypsychoeducationpsychoeducationalrecruitreducing suiciderelapse preventionskillsstandard caresuicidal behaviorsuicidal patientsuicidal risksuicide ratetime usetreatment as usualtrial comparingusability
项目摘要
ABSTRACT
Suicide is one of the top ten causes of death in the US and suicide rates have increased steadily over the last
twenty years. Currently, the most effective treatment options are cognitive behavioral therapies for suicide
prevention (CBT-SP), which have been shown to reduce both suicide attempt (SA) risk and suicide ideation
(SI). However, access to these treatments is limited because there is a shortage of mental healthcare
practitioners, especially suicide specialists. Furthermore, face-to-face therapy, which is the standard treatment
modality, is costly and logistically prohibitive. As a consequence, most people who experience suicidal
thoughts or behavior do not receive treatment. Oui Therapeutics therefore developed Aviva, a digital
therapeutic application accessed via smartphone. It is based on two CBT-SP protocols (the Brief Cognitive
Behavioral Therapy and Cognitive Therapy for Suicide Prevention protocol), is accessible, less costly than
current treatment options, and consistently implements CBT-SP with high fidelity. Ready accessibility is
particularly important for patients recently discharged after hospitalization for SA, as they are 40 times more
likely to make another SA within 30 days of discharge than the general population. Oui Therapeutics has
completed a Phase I SBIR study, creating a beta version of Aviva targeting the general adult population, and
testing the usability and feasibility of this version of Aviva in a single-group, open-label trial. During the 8-week
open-label trial, Aviva users showed clinically meaningful improvement on the Scale for Suicidal Ideation and
the Patient Health Questionnaire. For the proposed Phase II study, we aim to: 1) add capabilities to enhance
the usability of Aviva; 2a) determine the efficacy of Aviva in reducing SA and SI in a randomized controlled trial
(RCT), and 2b) determine the mechanisms of action in Aviva in the RCT. SAs and SIs will be tested by
enrolling 286 patients in a randomized controlled trial, administered at four clinical sites. Half of the participants
will receive treatment as usual plus Aviva, and the other half will receive treatment as usual plus a sham app.
We will use time-to-event survival analysis at 12 months to assess SAs and evaluate Aviva’s effects on SI at 6
months using a restricted likelihood repeated measures analysis. Aim 2b will be tested using mediation
analyses to examine Aviva’s effects on participants' scores on the Monetary Choice Questionnaire and the
Cognitive Emotion Regulation Questionnaire at three and six months. Upon successful completion of the
phase II study, we expect Aviva to be ready for distribution in the market. To ensure affordability and
accelerate the penetration of the product, Oui will also pursue licensing Aviva to a pharmaceutical company(s)
that will work with payers to have Aviva included in their formularies. Ultimately, Oui seeks to curtail the
multi-billion dollar economic costs associated with SA and SI and save lives by reducing suicide attempts by
50%.
抽象的
自杀是美国十大死因之一,自杀率近年来稳步上升
二十年来,最有效的治疗选择是自杀的认知行为疗法。
预防(CBT-SP),已被证明可以降低自杀企图(SA)风险和自杀意念
(SI) 然而,由于缺乏精神保健,获得这些治疗的机会有限。
护理人员,尤其是自杀专家 此外,面对面治疗是标准治疗方法。
方式,成本高昂且后勤上令人望而却步,因此,大多数经历过自杀的人。
Oui Therapeutics 因此开发了 Aviva,一种数字化疗法。
通过智能手机访问的治疗应用程序基于两个 CBT-SP 协议(简短认知)。
自杀预防方案的行为疗法和认知疗法),易于使用,成本低于
当前的治疗方案,并始终如一地实施具有高保真度的 CBT-SP。
对于 SA 住院后最近出院的患者尤其重要,因为他们的病情比以前多了 40 倍
出院后 30 天内可能会比普通人群再次进行 SA。
完成了 I 期 SBIR 研究,创建了针对一般成年人群的 Aviva 测试版,以及
在为期 8 周的单组、开放标签试验中测试该版本 Aviva 的可用性和可行性。
开放标签试验中,Aviva 用户在自杀意念量表和
对于拟议的第二阶段研究,我们的目标是:1)增加增强能力。
Aviva 的可用性;2a) 在随机对照试验中确定 Aviva 在减少 SA 和 SI 方面的功效
(RCT)和2b)确定Aviva在RCT中的作用机制将由SA和SI进行测试。
一项随机对照试验招募了 286 名患者,在四个临床中心进行,一半的参与者。
一半将照常接受治疗加 Aviva,另一半将照常接受治疗加假应用程序。
我们将在 12 个月时使用事件发生时间生存分析来评估 SA 并评估 Aviva 对 6 个月时 SI 的影响
将使用中介来测试目标 2b 的限制可能性重复测量分析。
分析检验 Aviva 对参与者货币选择问卷和
成功完成三个月和六个月时的认知情绪调节问卷。
第二阶段研究,我们预计 Aviva 已准备好在市场上销售,以确保可承受性和可负担性。
加速产品的渗透,Oui 还将寻求将 Aviva 授权给一家制药公司
Oui 将与付款人合作,将 Aviva 纳入他们的处方集。
与 SA 和 SI 相关的数十亿美元的经济成本,并通过减少自杀企图来挽救生命
50%。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Seth Feuerstein其他文献
Seth Feuerstein的其他文献
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{{ truncateString('Seth Feuerstein', 18)}}的其他基金
A Self-Guided Mobile Intervention for Adults with Binge Eating and Obesity
针对成人暴饮暴食和肥胖症的自助式移动干预
- 批准号:
10761112 - 财政年份:2023
- 资助金额:
$ 79.51万 - 项目类别:
An Efficacy Trial of Mobile Technology for Reducing and Preventing Adolescent Suicide
移动技术减少和预防青少年自杀的有效性试验
- 批准号:
10601611 - 财政年份:2021
- 资助金额:
$ 79.51万 - 项目类别:
Mobile Technology for Reducing and Preventing Adolescent Suicide
减少和预防青少年自杀的移动技术
- 批准号:
10154817 - 财政年份:2021
- 资助金额:
$ 79.51万 - 项目类别:
An Efficacy Trial of a Digital Therapeutic for Suicide Prevention
数字疗法预防自杀的功效试验
- 批准号:
10323492 - 财政年份:2020
- 资助金额:
$ 79.51万 - 项目类别:
An Efficacy Trial of a Digital Therapeutic for Suicide Prevention
数字疗法预防自杀的功效试验
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10449350 - 财政年份:2020
- 资助金额:
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A Digital Therapeutic to Advance the Delivery of Effective Interventions for Suicide Prevention
数字疗法可促进有效预防自杀干预措施的实施
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10010336 - 财政年份:2020
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