Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07350733

Cognitive Training for Student Sleep and Wellness

Cognitive Training for First-Year Student Sleep and Wellness

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
200 (estimated)
Sponsor
Carnegie Mellon University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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 200 first-year undergraduate students enrolled at one of the following universities: Carnegie Mellon University, the University of Notre Dame, Columbia University, Pennsylvania State 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=100) or a stress management program (N=100). 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALEquaMindfulness for attention monitoring and acceptance with a focus on concentration, clarity, and equanimity
BEHAVIORALCoping ControlProblem-solving for cognitive coping

Timeline

Start date
2026-01-12
Primary completion
2026-04-30
Completion
2026-04-30
First posted
2026-01-20
Last updated
2026-04-02

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT07350733. Inclusion in this directory is not an endorsement.