Effectiveness of HabitWorks and Symptom Tracking for Anxiety and Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- GAD-7
研究概览
简要总结
Our objective is to conduct a randomized controlled trial (RCT) that compares two digital interventions - Symptom Tracking and the HabitWorks app - in a sample of adults endorsing symptoms of anxiety or depression. We hope to obtain pilot data to support a fully powered RCT to test moderators:
- Target engagement (improvement in interpretation bias)
- Feasibility and acceptability of Symptom Tracking and HabitWorks and procedures for a general community sample
- Symptom and functioning measures
详细描述
HabitWorks is a personalized, transdiagnostic, smartphone-delivered interpretation bias intervention. Our pilot studies of HabitWorks revealed good acceptability, feasibility, and target engagement in a variety of populations (Beard, Ramadurai, et al., 2021; Beard, Beckham, et al., 2021). Our next step is to test effectiveness for anxiety and depression symptoms in a larger, community sample. Results will provide pilot data to support an R01 effectiveness trial. We will randomize adults with anxiety or depression to HabitWorks or a credible control arm and examine effects on interpretation bias, symptoms, and functioning.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 at the time of consent (19 in Nebraska, 21 in Puerto Rico based on age of consent)
- •Current US resident
- •Total score ≥ 3 on the Patient Health Questionnaire-2 (Kroenke et al., 2003) or Generalized Anxiety Disorder-2 (Spitzer et al., 2006), indicating at least mild depression and/or anxiety symptoms
- •24-hour access to an iPhone smartphone
- •ability to understand English
排除标准
- •No current psychiatric symptoms that would prevent informed consent, understanding of research procedures, or ability to complete the study (e.g., active symptoms of psychosis, mania)
- •No medical symptoms that would prevent informed consent, understanding of research procedures, or ability to complete the study (e.g., physical disability)
研究组 & 干预措施
HabitWorks + Symptom Tracking
Use of HabitWorks app 3 times/week for 4 weeks + weekly symptom tracking
干预措施: HabitWorks (Behavioral)
HabitWorks + Symptom Tracking
Use of HabitWorks app 3 times/week for 4 weeks + weekly symptom tracking
干预措施: Symptom TRacking (Behavioral)
Symptom Tracking
Symptom Tracking 3 times per week for 4 weeks
干预措施: Symptom TRacking (Behavioral)
结局指标
主要结局
GAD-7
时间窗: From enrollment to the end of followup period at 8 weeks
self-report measure of general anxiety symptoms, completed online via RedCap
次要结局
- Clinical Global Improvement Scale(post-treatment (4 weeks after enrollment))
研究者
Courtney Beard, PhD
Associate Professor
Mclean Hospital