Mindfulness Training and Respiration Biosignal Feedback - Study 3
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Equa Program Engagement
研究概览
简要总结
This study will evaluate engagement, usability, and psychological outcomes associated with participation in smartphone-based stress management or mindfulness training program among young adults. The study will compare multiple versions of a digital training program delivered through the Equa mobile application.
Participants will be individually randomized to one of several app-based training programs using a stratified randomization procedure. Each program consists of guided daily lessons completed over a 14-day period and is designed to support stress management and well-being through structured skill development activities.
Primary objectives include evaluating user satisfaction and usability of the digital platform and assessing changes in mindfulness-related skills and mental distress over time.
Participants will:
Complete surveys assessing demographics and psychological well-being at baseline, post-intervention, and one-month follow-up.
Complete a 14-day smartphone-delivered training program consisting of guided lessons while physiological data are collected using wearable sensors.
Some participants may receive additional in-app features designed to support personalized learning or engagement with training lessons.
Some participants will complete brief questionnaires before and after selected lessons to assess short-term changes associated with lesson participation.
详细描述
Investigators will recruit young adults to participate in a study examining usability, engagement, and psychological outcomes associated with smartphone-based stress management or mindfulness training programs. Participants will be informed that the study examines physiological responses during guided digital training lessons.
At study entry, participants will complete an online survey assessing demographics, prior meditation and stress-management experience, and psychological well-being. Participants will complete similar questionnaires at post-intervention and one-month follow-up, including measures of user satisfaction and usability of the digital training platform using standardized instruments (e.g., System Usability Scale and Mobile App Rating Scale).
Participants will be individually randomized to one of several 14-day app-based training programs delivered through the Equa platform.
During training lessons, physiological data (e.g., motion-derived signals) will be collected using smartphone sensors to characterize physiological responses associated with lesson participation.
Some participants may receive additional in-app features designed to provide personalized information or feedback related to lesson engagement or training progress. These features are delivered automatically through the application following lesson completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
A psychometrician and statistician on our team who will remain blind to participant study condition during data collection and analysis. All study investigators/staff will be blinded to condition assignment until randomization occurs; at this time only the participant and the project manager will be aware of participant's study condition. All other study personnel will remain blinded and conduct all remaining study assessments.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-30 years of Age
- •Fluent in English
- •Psychological distress
- •Interested in completing smartphone guided training sessions remotely for 14 days
- •Willing and able to wear physiological monitoring equipment
- •Willing to be randomized to one of three conditions
- •Located in the United States
- •Access to a smartphone without snapdragon processors to complete guided training sessions
排除标准
- •Currently pregnant
- •Current or previous diagnosis with psychosis or schizophrenia
研究组 & 干预措施
Feature-Enhanced Equa Training
Participants will complete a 14-day smartphone-delivered training program consisting of guided lessons through the Equa application. During lesson participation, physiological data will be collected using smartphone sensors to characterize participant responses during training activities. Participants assigned to this program version will receive additional in-app features designed to provide personalized information related to lesson engagement or training progress following lesson completion.
干预措施: Feature-Enhanced Equa Training Program (Behavioral)
Standard Equa Training Program
Participants will complete a 14-day smartphone-delivered training program consisting of guided lessons delivered through the Equa application. During lesson participation, physiological data will be collected using smartphone sensors to characterize participant responses during training activities. This program version provides the standard lesson experience within the application without additional personalized feedback features following lesson completion.
干预措施: Equa (Behavioral)
Stress Management Training Program
Participants will complete a 14-day smartphone-delivered training program focused on stress management and well-being skill development delivered through the Equa application. Lessons emphasize the development of evidence-informed coping skills, including thoughtful reflection, cognitive reappraisal of stressful experiences, and structured problem-solving strategies aimed at supporting adaptive responses to everyday stressors. Guided lessons are delivered through the same application interface and include comparable levels of interactivity and engagement activities as other study programs.
干预措施: Stress Management Training (Behavioral)
结局指标
主要结局
Equa Program Engagement
时间窗: Throughout the 21 day training period
In order to evaluate differential engagement over the 21 day training period, we will sum total lessons (out of 14) and total minutes of training across lessons as primary outcome variables. One-way ANOVAs will compare conditions at post-treatment on each of these two engagement outcomes. ANOVA provides a simple and compelling tool but we will extend ANOVA results using survival analysis on lessons completed to detect training condition differences in the time points at which engagement significantly drops off.
次要结局
- Extended Equa Program Engagement(Throughout the 51 day intervention plus follow-up period.)
研究者
David Creswell
Co-Founder, Chief Science Officer
Equa Health