The Lucida Project
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,500
- 主要终点
- Change in Physical Health Questionnaire depression scale (PHQ-9)
研究概览
简要总结
The purpose of this clinical trial is to learn about the impact of the Healthy Minds Program (HMP) on measurements of well-being. The main question it aims to answer is:
- Does use of HMP reduce symptoms of depression?
Participants will complete a 4-week well-being program.
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
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all participants:
- •Age 18 to 84
- •Elevated depressive symptoms: PHQ-9 ≥ 10; Healthy controls: PHQ-9 <5
- •Inclusion Criteria - randomized participants:
- •Proficient in English to try to unsure understanding of study requirement, consent forms and questionnaires that can often us medical terms not routinely used in general conversation.
- •Able to provide informed consent
- •Have access to a smartphone that can download apps from Google Play or the Apple App Store
- •Ability to receive text messages
- •Indicate interest in participation after being informed of restrictions to payment
排除标准
- •Regular daily meditation practice for past 6 months or regular weekly meditation practice for past 12 months
- •Attended a meditation retreat or a yoga/body practice retreat with a significant meditation component
- •Previous use of Healthy Minds Program app
- •Current suicidal intent and/or high self-injury risk (determined by PHQ-9 item 9 and BDI item 9)
- •Self-reported history of psychosis
- •Self-reported history of mania
- •Living or traveling outside the US during the whole study participation period (trips outside US after the interview phase is not an exclusion)
- •Hearing impairments
- •Prior participation
- •Self report pregnancy
研究组 & 干预措施
Healthy Minds Program (HMP)
Participants will use HMP
干预措施: Healthy Minds Program (Device)
Active control group
Participants will play mental games
干预措施: Healthy Minds Brian Games (Behavioral)
Usual care group
干预措施: Care as usual (Behavioral)
结局指标
主要结局
Change in Physical Health Questionnaire depression scale (PHQ-9)
时间窗: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months
The PHQ-9 is a 9-question screening tool used to assess depression severity. Each of the 9 items evaluates symptoms over the last 2 weeks and is scored from 0 (not at all) to 3 (nearly every day), resulting in a total possible score ranging from 0 to 27. Higher scores indicate higher depression severity.
次要结局
- Change in self-referential thought(Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months)
- Change in Generalized Anxiety Disorder (GAD-7) score(Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months)
- Change in Flourishing Measure(Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months)
- Change in PROMIS Sleep Disturbance(Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months)
- Change in performance on the behavioral Self-Referential Encoding Task (SRET)(Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months)
- Inflammatory Biomarkers: C-reactive Protein (CRP)(Baseline and 3 month follow-up)
- Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10(Baseline and 3 month follow-up)
- Microbiome Alpha Diversity: Species Richness(Baseline and 3 month follow-up)