Cognitive Training for Student Sleep and Wellness

NCT07350733 | Recruiting

• 1 other identifier: FP00012477
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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.

Conditions

Sleep; Well-Being (Psychological Flourishing)

Keywords

Mindfulness; University Student; Sleep; Stress

Outcome Measures

Primary Outcomes (7)

• Intervention Adherence

  Number of lessons completed during the intervention period

  From intervention program start at week 4 to end of treatment at week 6

• App Engagement

  Self-reported measure of engagement following each lesson on a scale from 1-Not at all, to 5- Extremely.

  From intervention program start at week 4 to end of treatment at week 6

• User Satisfaction

  Self-reported user satisfaction with the intervention lesson measured on a scale of 1- Not at all, to 5- Extremely

  From intervention program start at week 4 to end of treatment at week 6

• Change in Self-Reported Perceived Stress

  The 10-item Perceived Stress Scale is a self-reported assessment of perceptions of stress over the past month. Total scores range from 0 to 40, with higher scores indicating higher levels of perceived stress.

  Change from baseline to 1-week post and 2-month follow-up

• Change in Self-Reported Depressive Symptomatology

  The Patient Health Questionnaire is an eight-item instrument that will be utilized as a brief measure of depression severity. A total score ranges from 0 to 24 and is calculated by adding each of the nine items' scores. A higher total score signifies more severe depression levels.

  Change from baseline to 1-week post and 2-month follow-up

• Total Nightly Sleep Duration

  Nightly sleep duration as measured in minutes by FitBit wearable devices.

  From study week 1 through 2-month follow-up

• Grade Point Average

  Student university cumulative grade point average calculated at the end of the semester.

  From study week 1 through 2-month follow-up

Secondary Outcomes (10)

• Change in Self-Reported Loneliness

  Change from baseline to 1-week post and 2-month follow-up

• Change in Self-Reported 2-way Social Support

  Change from baseline to 1-week post and 2-month follow-up

• Change in Self-Reported Brief Resilience

  Change from baseline to 1-week post and 2-month follow-up

• Change in Self-Reported Physical Health Symptoms

  Change from baseline to 1-week post and 2-month follow-up

• Change in Self-Reported Sleep Quality

  Change from baseline to 1-week post and 2-month follow-up

Study Arms (2)

Mindfulness Meditation

ACTIVE COMPARATOR

14-day smartphone based mindfulness meditation training intervention consisting of a personalized introduction, a 10 to 15-minute audio-guided lesson, plus daily life homework practice (3-10 minutes) each day.

Behavioral: Equa

Stress Management Training

ACTIVE COMPARATOR

14-day smartphone based training intervention focused on coping strategies consisting of a 10 to 15-minute audio-guided lesson, plus daily life homework practice (3-10 minutes) each day.

Behavioral: Coping Control

Interventions

Equa BEHAVIORAL

Mindfulness for attention monitoring and acceptance with a focus on concentration, clarity, and equanimity

Mindfulness Meditation

Coping Control BEHAVIORAL

Problem-solving for cognitive coping

Stress Management Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Carnegie Mellon University, Notre Dame, Columbia, or Penn State undergraduate student in their 1st year of study
• years of age or older
• Have a data-enabled smartphone
• Speak English
• On campus for the duration of the Spring 2026 semester

You may not qualify if:

• Under 18 years of age at time of enrollment
• Not enrolled full-time as a student

Sponsors & Collaborators

• Carnegie Mellon University: lead

Study Sites (4)

University of Notre Dame

Notre Dame, Indiana, 46556, United States

RECRUITING

Columbia University

New York, New York, 10027, United States

RECRUITING

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

RECRUITING

Central Study Contacts

Sarah Wu

CONTACT

(412) 238-7896‬; sarahwu@andrew.cmu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 20, 2026
• Study Start: January 12, 2026
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

US (4)