Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07350733
Brief Summary:
This randomized control trial (RCT) explores two potential stress reduction interventions: a digital mindfulness program personalized for first year college students and a problem-solving based stress management program. These interventions were chosen because they rely on evidence-based approaches to stress management: problem-solving for cognitive coping and mindfulness for attention monitoring and acceptance with a focus on concentration, clarity, and equanimity. This selection allows for the assessment of the comparative efficacy of these methods in addressing student stress and stress-related outcomes (sleep duration, mental health, and academic success). Personalization to the college student offers the potential for greater engagement and user satisfaction by tailoring the program while maintaining the empirically driven structure of a digital mindfulness program. The investigators predict greater engagement and satisfaction will lead to higher adherence, and thus more skill-building. In this small RCT, first year college students will complete one of the two intervention conditions: Equa and MyTime. This will allow for the exploration of the effects of personalized mindfulness training compared to an active control condition.
This work has the potential for identifying effective, low-cost tools to help young adults manage their stress and stress-related health and may inform theory and future work on stress modification strategies for other populations. The main trials aims are:
Specific Aim 1. To explore whether a personalized mindfulness intervention (Equa) leads to greater adherence, engagement and use satisfaction compared to a digital stress management program.
Specific Aim 2. To explore whether a personalized mindfulness intervention leads to greater improvements in student stress and stress-related outcomes compared to a problem solving-based digital stress management program. Outcomes include perceived stress, depressive symptoms, nightly sleep duration, and grades.
Detailed Description:
A sample of 100 first-year undergraduate students enrolled at Carnegie Mellon University will be recruited to participate in this study for the duration of the spring semester of 2026. Participants will be randomly assigned to complete 14-days of smartphone audio-guided lessons of either mindfulness (N=50) or a stress management program (N=50). Participants will complete baseline measures of stress, psychological well-being, and health behaviors. Participants will also be given a wearable device (FitBit) that will measures sleep and physical activity throughout the semester. For the 7 days prior to the intervention start and 7 days following the completed 14 day intervention, students will complete daily diaries that assess their thoughts, feelings, and experiences throughout the day. Participants will complete two more online surveys with similar questionnaires as the baseline assessment, one within 10 days of completing the intervention, and one at the end of the semester.
Study:
NCT07350733
Study Brief:
Protocol Section:
NCT07350733