STEPS - Stress Training and Engagement Via Phone-Based Systems

Официальное название

Mindfulness Training and Respiration Biosignal Feedback - Study 3

Обзор

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.

Подробное описание

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.

Physiological and questionnaire measures will allow investigators to evaluate usability, engagement, and changes in mindfulness-related skills and psychological well-being associated with participation in the training programs.

Вмешательства

• Поведенческое Equa
  Participants will be randomly assigned to a 14-unit smartphone meditation program group that involves completing a 2-10 minute daily guided practice on their phones. Participants complete 14 units of mindfulness meditation curriculum that consists of learning and practicing techniques to improve concentration, sensory clarity, and equanimity (Equa meditation app). Physiological measures will be tracked throughout the duration of lessons.
• Поведенческое Feature-Enhanced Equa Training Program
  Participants will be randomly assigned to complete a 14-unit smartphone-delivered guided training program consisting of brief daily lessons lasting approximately 2-10 minutes. Lessons are delivered through the Equa mobile application and focus on the development and practice of mindfulness skills designed to support concentration, awareness, and emotional well-being. Physiological data will be collected during lesson participation using smartphone sensors to characterize participant responses du
• Поведенческое Stress Management Training
  The CC program, called R\&R, is a well matched and previously validated digital stress management training. R\&R program lessons will focus on the development of three coping effectiveness skills: (a) thoughtful reflection; (b) reappraisal and reframing past and anticipated stressful events; and (c) problem solving, such as analyzing and solving personal problems.

Первичные конечные точки

• Equa Program Engagement [Срок оценки: Throughout the 21 day training period]
• Symptoms of Depression [Срок оценки: From baseline to 6 weeks after (1-month follow-up)]
• Loneliness [Срок оценки: From baseline to 6 weeks after (1-month follow-up)]
• Anxiety [Срок оценки: From baseline to 6 weeks after (1-month follow-up)]
• Perceived Stress [Срок оценки: From baseline to 6 weeks after (1-month follow-up)]

Вторичные конечные точки (7)

• User Satisfaction [Срок оценки: From enrollment to the end of treatment at up to week 6]
• Mean trait mindfulness as assessed by the Toronto Mindfulness Scale-Trait [Срок оценки: From enrollment to the end of treatment at up to week 6]
• State Trait Mindfulness Scores [Срок оценки: Throughout the intervention (up to 3 weeks)]
• Self-efficacy for practicing meditation or stress management [Срок оценки: From baseline to 6-weeks (1 month follow-up)]
• Concentration, Sensory Clarity, and Equanimity [Срок оценки: From enrollment to the end of treatment at up to week 6]
• Physical Pain [Срок оценки: From baseline to 6 weeks after (1-month follow-up)]
• Extended Equa Program Engagement [Срок оценки: Throughout the 51 day intervention plus follow-up period.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Currently pregnant
• Current or previous diagnosis with psychosis or schizophrenia

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• 4615 Forbes Ave — Pittsburgh

Идентификаторы

NCT: NCT07639697 · 12015 · 1R44MH134709-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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