SleepNCT07350733
Cognitive Training for Student Sleep and Wellness
A study testing Equa in people with Sleep and Well-Being (Psychological Flourishing), run by Carnegie Mellon University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep, Well-Being (Psychological Flourishing)
- What is being tested?
- Equa
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- 12 Jan 2026to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Carnegie Mellon University, Notre Dame, Columbia, or Penn State undergraduate student in their 1st year of study
- 18 years of age or older
- Have a data-enabled smartphone
- Speak English
- On campus for the duration of the Spring 2026 semester
Who cannot join
- Under 18 years of age at time of enrollment
- Not enrolled full-time as a student
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Columbia University
New York, New York, 10027
University of Notre Dame
Notre Dame, Indiana, 46556
Carnegie Mellon University
Pittsburgh, Pennsylvania, 15213
Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: Cognitive Training for First-Year Student Sleep and Wellness
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:
Read more
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.
Read the 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
- Sleep, Well-Being (Psychological Flourishing)
- Being tested
- Equa, Coping Control
- Keywords
- Mindfulness, University Student, Sleep, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EquaBehavioural
Mindfulness for attention monitoring and acceptance with a focus on concentration, clarity, and equanimity
Coping ControlBehavioural
Problem-solving for cognitive coping
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Coping Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Adherence
Number of lessons completed during the intervention period
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From study week 1 through 2-month follow-up
Secondary outcomes (10)
Change in Self-Reported Loneliness
The UCLA Loneliness scale will be used to measure subjective feelings of loneliness and social isolation. A total score that ranges from 20 to 80 is calculated by summing the score of each item. A higher total score signifies increased feelings of loneliness.
Measured: Change from baseline to 1-week post and 2-month follow-up
Change in Self-Reported 2-way Social Support
The 2-way social support scale will be used to assess experiences giving or receiving emotional and instrumental support. Total scores ranging from 0-60 and subscales (giving/receiving instrumental/emotional support) ranging from 0-15 are calculated , with a higher score indicating greater social support.
Measured: Change from baseline to 1-week post and 2-month follow-up
Change in Self-Reported Brief Resilience
The brief resilience scale measures an individual's ability to bounce back from stress, adversity, and challenging life circumstances. An average is calculated across 6 items, with higher scores signifying greater brief resiliency. Scores can range from 1 to 5.
Measured: Change from baseline to 1-week post and 2-month follow-up
Change in Self-Reported Physical Health Symptoms
The Cohen-Hoberman Inventory of Physical Symptoms assess how much 33 common physical symptoms have bothered or distressed an individual over the past two weeks from 0 (not bothered) to 4 (extremely bothered). Items are summed to create a composite score ranging from 0-132, with higher scores indicating more distress from physical symptoms.
Measured: Change from baseline to 1-week post and 2-month follow-up
Change in Self-Reported Sleep Quality
The Pittsburgh Sleep Quality Index assess sleep quality over the past month. A global sleep quality score is calculated (ranging 0-21), with higher scores indicating worse sleep quality.
Measured: Change from baseline to 1-week post and 2-month follow-up
Change in Self-Reported Sleep Reactivity
The Ford Insomnia Response to Stress Test is a 9-item measure of sleep reactivity. Participants rate how likely (1 - not likely, to 4 very likely) it is for them to have difficulty sleep in different scenarios, with total scores ranging from 9-36. Higher scores indicate greater stress-induced sleep reactivity.
Measured: Change from baseline to 1-week post and 2-month follow-up
Change in Self-Reported Anxiety
The Generalized Anxiety Disorder 2-item scale measures anxiety symptoms over the past two weeks. Participants rate how bothered they have been by problems on a scale from 0 - not at all, to 3 - nearly every day. Scores are totaled to create a composite score, with higher scores indicating greater generalized anxiety.
Measured: Change from baseline to 1-week post and 2-month follow-up
Change in Engagement of Enjoyable Activities
The Pittsburgh Enjoyable Activities Test is a brief, ten-item measure that will be used to assess the frequency of a participant's engagement in various activities on a scale of 0 (never) to 4 (every day). A total score ranges from 0 to 40 where a higher score reflects the increased frequency of participation in enjoyable activities.
Measured: Change from baseline to 1-week post and 2-month follow-up
Change in Self-Reported Mindfulness
Evaluated using the The Five Facet Mindfulness Questionnaire, a 24-item scale measuring mindfulness. Each item is rated on a scale from 1=never or very rarely true to 5= very often or always true, with a higher total score indicating greater mindfulness tendencies.
Measured: Change from baseline to 1-week post and 2-month follow-up
Change in Self-Reported Social and Academic Fit
The Sense of Social and Academic Fit Scale contains 17-items assessing perceptions of both social and academic fit. Participants respond from 1- Strongly Disagree to 7 - Strongly Agree, summed to create a composite score with higher values indicating higher feelings of belongingness.
Measured: Change from baseline to 1-week post and 2-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start12 Jan 2026
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carnegie Mellon University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Creswell, Carnegie Mellon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350733
- Sponsor's protocol ID
- FP00012477
- Status last verified
- May 2026
- First submitted
- 25 Dec 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training for First-Year Student Sleep and Wellness
- ClinicalTrials.gov ID
- NCT07350733
- Acronym / sponsor ID
- FP00012477
- Conditions
- Sleep, Well-Being (Psychological Flourishing)
- Keywords
- Mindfulness, University Student, Sleep, Stress
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Carnegie Mellon UniversityUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Meditation | Active comparator | Behavioral: Equa14-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. |
| Stress Management Training | Active comparator | Behavioral: Coping Control14-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Carnegie Mellon University, Notre Dame, Columbia, or Penn State undergraduate student in their 1st year of study
- 18 years of age or older
- Have a data-enabled smartphone
- Speak English
- On campus for the duration of the Spring 2026 semester
Key exclusion criteria (2 listed)
- Under 18 years of age at time of enrollment
- Not enrolled full-time as a student
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EquaMindfulness for attention monitoring and acceptance with a focus on concentration, clarity, and equanimity | Behavioural | Mindfulness Meditation |
| Coping ControlProblem-solving for cognitive coping | Behavioural | Stress Management Training |
Primary outcome
Intervention Adherence
Time frame: From intervention program start at week 4 to end of treatment at week 6
Number of lessons completed during the intervention period
App Engagement
Time frame: From intervention program start at week 4 to end of treatment at week 6
Self-reported measure of engagement following each lesson on a scale from 1-Not at all, to 5- Extremely.
User Satisfaction
Time frame: From intervention program start at week 4 to end of treatment at week 6
Self-reported user satisfaction with the intervention lesson measured on a scale of 1- Not at all, to 5- Extremely
Change in Self-Reported Perceived Stress
Time frame: Change from baseline to 1-week post and 2-month follow-up
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 in Self-Reported Depressive Symptomatology
Time frame: Change from baseline to 1-week post and 2-month follow-up
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.
Total Nightly Sleep Duration
Time frame: From study week 1 through 2-month follow-up
Nightly sleep duration as measured in minutes by FitBit wearable devices.
Grade Point Average
Time frame: From study week 1 through 2-month follow-up
Student university cumulative grade point average calculated at the end of the semester.
10 secondary outcomes
Change in Self-Reported Loneliness
Time frame: Change from baseline to 1-week post and 2-month follow-up
Change in Self-Reported 2-way Social Support
Time frame: Change from baseline to 1-week post and 2-month follow-up
Change in Self-Reported Brief Resilience
Time frame: Change from baseline to 1-week post and 2-month follow-up
Change in Self-Reported Physical Health Symptoms
Time frame: Change from baseline to 1-week post and 2-month follow-up
Change in Self-Reported Sleep Quality
Time frame: Change from baseline to 1-week post and 2-month follow-up
Change in Self-Reported Sleep Reactivity
Time frame: Change from baseline to 1-week post and 2-month follow-up
Change in Self-Reported Anxiety
Time frame: Change from baseline to 1-week post and 2-month follow-up
Change in Engagement of Enjoyable Activities
Time frame: Change from baseline to 1-week post and 2-month follow-up
Change in Self-Reported Mindfulness
Time frame: Change from baseline to 1-week post and 2-month follow-up
Change in Self-Reported Social and Academic Fit
Time frame: Change from baseline to 1-week post and 2-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Equa in people with Sleep and Well-Being (Psychological Flourishing), run by Carnegie Mellon University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Adherence (time frame: From intervention program start at week 4 to end of treatment at week 6). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.