Feasibility and Acceptability of a Digital Therapeutic for Adolescent Depressive Symptoms in Cardiology and Gastroenterology
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Feasibility of intervention - Eligibility
研究概览
简要总结
The primary aim of this pilot study is to assess the feasibility, acceptability, and preliminary evidence of efficacy of a self-guided, cognitive behavioral therapy (CBT)-based mobile app intervention (SparkRx) for symptoms of depression among adolescents being treated in specialty medical care settings at Children's Hospital of Los Angeles (CHLA).
详细描述
Self-report assessments will be collected at pre, post and 1-month follow up time points. Weekly PHQ-8 assessments will also be collected during the 5-week intervention as well as at pre, post and 1- month follow up time points.
Study aims involve evaluating:
- Feasibility of recruiting and enrolling adolescents with elevated symptoms of depression from the Cardiology and Gastroenterology programs at CHLA.
- Retention, program adherence, completion, and withdrawal rates.
- Safety of the intervention, including reported adverse and serious adverse events
- Perceived utility, usability, and enjoyment of the SparkRx app by adolescents
- Clinically significant changes in pre- to -post treatment depressive symptoms and persistence of such gains at 1 month follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •13-22 years of age at time of enrollment
- •Moderate-severe self-reported symptoms of depression at baseline (PHQ-8 >=5)
- •Under the care of a US-based healthcare provider and willing and able to provide the name and contact information of the provider during consent
- •English fluency or proficiency and literacy of adolescent and consenting legal guardian, if required
- •Access to an eligible mobile device (capable of installing the app) and regular internet access
- •Willing to provide informed e-consent/assent and have legal guardian willing to provide informed e consent (if required)
排除标准
- •Change in concurrent treatment (medication, and/or psychotherapy) for depression 30 days prior to study enrollment
- •Suicide attempt within the past year
- •Active suicide ideation with intent
- •Previously participated in user testing or clinical testing of the Spark app
- •Any condition, comorbidity, or event that, in the opinion of the investigator, will prevent the participant from adhering to the protocol or benefitting from the treatment (e.g., unable to perform informed assent or consent, treatment resistance as determined by investigator) or will prevent investigators from being able to ensure safety (e.g., will be leaving the country during study time period)
结局指标
主要结局
Feasibility of intervention - Eligibility
时间窗: Screening
Percent of potential participants eligible to participate
Feasibility of intervention - Participant willingness
时间窗: Screening
Percent of eligible participants willing to participate
Participant satisfaction with the SparkRx app
时间窗: 5 weeks
Acceptability of intervention. Measured by the User Experience (UXR) questionnaire. Includes questions from the UMUX-Lite; a two-item questionnaire that assesses the usability of the mobile application. Questions have seven response options from Strongly agree to Strongly disagree. Includes questions from the HaTs questionnaire; an open-ended questionnaire that assesses respondents' experiences with the product and provides options for feedback.
Feasibility of intervention - Adherence
时间窗: 5 weeks
Adherence to program: percent of enrolled participants completing all modules by post-treatment
次要结局
- Change in legal-guardian reported health-related quality of life(Change from screening to post-intervention (5 weeks))
- Change in participant-reported health-related quality of life(Change from screening to post-intervention (5 weeks))
- Change in participant-rated anxiety symptoms(Change from screening to post-intervention (5 weeks))
- Average treatment related engagement rating(5 weeks)
- Average treatment related program adherence(5 weeks)
- Change in legal guardian-reported depressive symptoms(Change from screening to post-intervention (5 weeks))
- Average treatment related program engagement(5 weeks)
- Change in depressive symptoms(Change from screening to post-intervention (5 weeks))
- Average treatment related usability rating(5 weeks)