Limbix Spark: a CBT-based mobile intervention for adolescent depression
Limbix Spark: a CBT-based mobile intervention for adolescent depression
批准号:
10451988
负责人:
SCOTT N COMPTON
金额:
$172.1万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2021
资助国家:
美国
项目状态:
已结题
起止时间:
2021-02-01 至 2024-10-31
关键词:
AdolescentAdverse eventAffectAgeBehavioralCaringChildhoodClinicClinicalClinical effectivenessCognitive TherapyDevelopmentDiagnosisDouble-Blind MethodEnrollmentFeasibility StudiesFeedbackGatekeepingGenerationsGoalsHealth Services AccessibilityHomeIncidenceIndustryInternationalInterventionInterviewLifeMajor Depressive DisorderMedicalMental DepressionMental HealthMental disordersMissionMonitorNational Institute of Mental HealthNotificationOutcomeParticipantPatient RecruitmentsPatientsPharmacologyPhasePhase II Clinical TrialsPlacebo ControlPopulationPrimary Health CareProviderPsychiatristRandomizedRandomized Clinical TrialsRegulationResearchSafetySocial isolationTechnologyTeenagersTestingTimeTrainingUnderserved PopulationUnited StatesValidationVeteransWaiting ListsYouthanxiety symptomsbasecare providerschild depressionclinically significantcommercializationcomorbiditycost effectivedepressive symptomsdesigndigitaldigital healthdigital treatmenteconomic impacteffective therapyexpectationexperiencefeasibility trialfunctional outcomesimprovedmeetingsnew technologypatient safetyphase 2 designspleasurepreferenceprimary care settingprimary outcomeprogramspsychoeducationrate of changerecruitsecondary outcomeskillssocial stigmasuicide rateusability
中文摘要
项目摘要
英文摘要
Project Abstract
Depression affects more than 3.2 million adolescents in the USA, with rising incidence and suicide rates that
carry devastating personal, societal, and economic impact. Effective care for adolescent depression is limited
due to lack of access, shortage of providers, long waitlists, stigma, and ineffective or partially effective
pharmacological options. Many adolescents with depression are initially diagnosed and receive treatment from
primary care providers, who, unfortunately, often have limited time, training, and options to be effective
gatekeepers for treatment. There is an urgent need for accessible, cost-effective, and clinically-validated
treatment options for adolescents diagnosed with depression, particularly in primary care settings. Digital
health interventions represent an exciting and promising new direction for mental health treatment with strong
potential to increase access to care. Such technology is especially critical and timely during this period of
mandated physical distancing, which is expected to increase social isolation and exacerbate difficulties in
receiving care. Currently available commercial digital health options widely lack clinical validation, cannot make
strong medical claims, and are not specifically designed for adolescents. We aim to develop an FDA-cleared,
self-guided, cognitive behavioral therapy (CBT)-based mobile program (Limbix Spark) to be prescribed by
primary care providers and psychiatrists and commercialized for at-home patient use as first line treatment.
Limbix Spark implements behavioral activation, a key CBT skill that provides a sense of pleasure or mastery
through self-monitored activities to reduce depressive symptoms and improve functional outcomes. Given
youth ease with and preference for technological solutions, an age-appropriate and engaging mobile
intervention can be both beneficial and enjoyable. Building on outcomes from a feasibility trial demonstrating
high feasibility and engagement, and preliminary evidence of clinically meaningful reductions in depressive
symptoms, in Phase I of the proposed Fast Track, we will conduct rigorous testing to optimize our Limbix Spark
program and show high usability, build a regulatory compliant platform, and prepare for a Phase II clinical trial.
In Phase II, we will demonstrate clinical effectiveness of Limbix Spark by conducting a double-blind, placebo
controlled, randomized clinical trial with patients recruited and enrolled from primary care and psychiatric
clinics. The team, led by veteran entrepreneurs, research professionals, industry leaders, and clinical experts,
is singularly qualified to conduct the proposed research and commercialize Limbix Spark as an adolescent
depression prescription digital therapeutic, accelerating access to care for a severely underserved population.
期刊论文(1)
专著(0)
科研奖励(0)
会议论文
DOI:
10.3389/fdgth.2022.890081
发表时间:
2022
期刊:
FRONTIERS IN DIGITAL HEALTH
影响因子:
--
作者:
[Strauss, Gabriel, Flannery, Jessica E., Vierra, Elise, Koepsell, Xin, Berglund, Emily, Miller, Ian, Lake, Jessica I.]
通讯作者:
Lake, Jessica I.
2/4 Adapting Treatments for Suicidal College Students: A Multisite Trial
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批准号:9805270
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项目类别:
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资助金额:$78.4万
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负责人:SCOTT N COMPTON
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依托单位:
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依托单位:
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项目类别:
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负责人:SCOTT N COMPTON
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依托单位:
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资助金额:$74.79万
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依托单位:
Data Management and Analysis Core
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资助金额:$25.3万
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依托单位:
Data Management and Analysis Core
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批准号:10523406
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资助金额:$28.25万
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财政年份:2017
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依托单位:
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资助金额:$33.26万
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依托单位:
Statistics and Methodology in Clinical Trials
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项目类别:
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资助金额:$17.12万
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财政年份:2007
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负责人:SCOTT N COMPTON
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依托单位:
Statistics and Methodology in Clinical Trials
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批准号:7254290
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项目类别:
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资助金额:$13.57万
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财政年份:2007
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负责人:SCOTT N COMPTON
-
依托单位:
Statistics and Methodology in Clinical Trials
-
批准号:8107646
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项目类别:
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资助金额:$17.15万
-
财政年份:2007
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负责人:SCOTT N COMPTON
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依托单位:
Statistics and Methodology in Clinical Trials
-
批准号:7882342
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项目类别:
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资助金额:$17.1万
-
财政年份:2007
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负责人:SCOTT N COMPTON
-
依托单位:
Statistics and Methodology in Clinical Trials
-
批准号:7474688
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项目类别:
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资助金额:$16.95万
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财政年份:2007
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负责人:SCOTT N COMPTON
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依托单位:
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依托单位:
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项目类别:
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财政年份:2001
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负责人:SCOTT N COMPTON
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依托单位:
5/6-Child/Adolescent Anxiety Multimodal Extended Long-Term Study (CAMELS)
-
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项目类别:
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资助金额:$24.96万
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财政年份:2001
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负责人:SCOTT N COMPTON
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依托单位:
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批准号:2241924
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项目类别:
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资助金额:$1.18万
-
财政年份:1994
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负责人:SCOTT N COMPTON
-
依托单位:
Data Management and Analysis Core
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-
项目类别:
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资助金额:$30.77万
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财政年份:--
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负责人:SCOTT N COMPTON
-
依托单位:
海外基金