Feasibility and Acceptability of a Digital Therapeutic for Adolescent Depressive Symptoms in Hematology/Oncology and Weight Management
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Feasibility of intervention: Module adherence
研究概览
简要总结
The primary aims of the proposed research are to assess the feasibility, acceptability, and preliminary evidence of efficacy of a self-guided, cognitive behavioral therapy (CBT)-based mobile app intervention (SparkRx) for the treatment of adolescents presenting with symptoms of depression in specialty medical care settings (e.g.Hematology/Oncology, Weight Management, etc.) at Children's Health System of Texas (CHST).
详细描述
The primary aims of the proposed research are to assess the feasibility, acceptability, and preliminary evidence of efficacy of a self-guided, cognitive behavioral therapy (CBT)-based mobile app intervention (SparkRx) for the treatment of adolescents presenting with symptoms of depression in specialty medical care settings (e.g.Hematology/Oncology, Weight Management, etc.) at Children's Health System of Texas (CHST).
These aims will be accomplished by evaluating:
- Feasibility of recruiting and enrolling adolescents with mild to severe symptoms of depression from specialty care medical programs at CHST.
- Retention, program adherence, completion, and withdrawal rates.
- Perceived utility, usability, and enjoyment of the program by adolescents
- Clinically significant changes between pre- to -post treatment and persistence of such gains at 1 month follow up.
- Preliminary evidence of efficacy defined as a statistically significant difference in the eight-item Patient Health Questionnaire (PHQ-8) scores (p < 0.05) between Spark and an educational control at post-treatment.
- Safety of the intervention, including rates of reported adverse events and adverse device effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Between the ages of 13 and 22
- •Moderate- severe self-reported symptoms of depression at baseline (PHQ-8 >= 5)
- •Have a comorbid medical condition and under the care of a healthcare provider at CHST
- •English fluency and literacy of adolescent; English or Spanish fluency and literacy of consenting legal guardian if under 18
- •Access to a compatible smartphone (or other device) and operating system (i.e., capable of installing the app from the Google Play or Apple App Store; list will be provided to participants) and regular internet access
- •Willing to provide informed consent/assent and have legal guardian willing to provide informed consent (if required)
排除标准
- •Concurrent psychotherapy: Have met with a psychologist for intervention (not assessment) for 30 minutes or more, more than once in the 3 weeks prior to enrollment as determined by the study team
- •Change in psychotropic medication (initiation or change in dose) within the past 30 days prior to enrollment
- •Suicide attempt within the past year as determined at eligibility screening
- •Active suicidal ideation with intent as determined at eligibility screening
- •Previously participated in user testing or clinical testing of the Spark app
- •Participating in any other psychiatric or psychological treatment based clinical research at the time of enrollment and up to two months prior to enrollment or planning to participate in any other psychiatric or psychological treatment based clinical research during the study intervention period (5 weeks)
- •Any condition, comorbidity, or event that, in the opinion of the investigator, will prevent the participant from adhering to the protocol or benefiting from the treatment (e.g., unable to provide informed assent or consent) 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: Module adherence
时间窗: 5 weeks
Adherence to program determined by average number of modules completed
Feasibility of intervention: Participant willingness
时间窗: Screening
Percent of eligible participants willing to participate
Feasibility of intervention: Eligibility
时间窗: Screening
Percent of potential participants eligible to participate
Feasibility of intervention: Completion adherence
时间窗: 5 weeks
Adherence to program determined by percent of enrolled participants completing all modules within 5 weeks and by post-treatment
Feasibility of intervention: Time adherence
时间窗: 5 weeks
Adherence to program determined by engagement with program (time spent in app)
次要结局
- Adverse events(11 weeks)
- Engagement(5 weeks)
- Usability(5 weeks)
- Change in depressive symptoms(5 weeks)