Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Equa | Behavioral | Mindfulness for attention monitoring and acceptance with a focus on concentration, clarity, and equanimity |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to 1-week post and 2-month follow-up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Notre Dame | Notre Dame | Indiana | 46556 | United States | ||
| Columbia University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Coping Control | Behavioral | Problem-solving for cognitive coping |
|
| 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 |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Change from baseline to 1-week post and 2-month follow-up |
| New York |
| New York |
| 10027 |
| United States |
| Carnegie Mellon University | Pittsburgh | Pennsylvania | 15213 | United States |
| Pennsylvania State University | University Park | Pennsylvania | 16802 | United States |