DepressionPhase 2LEMURS-PNCT05841979
The Lived Experiences Measured Using Rings Pilot Study
A Phase 2 study testing Moodlifters, Physical Activity and Nature Experiences in people with Depression and Stress, run by University of Vermont at 1 site in United States.
Trial summary
The transition to college is a period of elevated risk for a range of mental health conditions. For students with pre-existing mental health diagnoses, the added pressures can exacerbate challenges. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Depression, Stress, Sleep
- What is being tested?
- Moodlifters, Physical Activity and Nature Experiences
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 1 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Current undergraduate student in their first year of school
- own a mobile device
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The transition to college is a period of elevated risk for a range of mental health conditions. For students with pre-existing mental health diagnoses, the added pressures can exacerbate challenges. Although colleges and universities strive to provide mental health support to their students, the high demand for these services makes it difficult to provide scalable cost-effective solutions. To address these issues, the present study aims to compare the efficacy of three different treatments using a large cohort of 600 students transitioning to college. Interventions were selected based on their potential for generalizability and cost-effectiveness on college campuses. The randomized controlled trial will assign 150 participants to one of four arms: 1) group-based therapy, 2) physical activity program, 3) nature experiences group, or 4) self-monitoring condition as the control group. In addition, biometric data will be collected from all participants using a wearable device to develop algorithmic predictions of mental and physical health functioning. Once recruitment is complete, modeling strategies will be used to evaluate the outcomes and effectiveness of each intervention. The findings of this study will provide evidence as to the benefits of implementing scalable and proactive interventions using technology with the goal of improving well-being and success of new college students.
- Conditions
- Depression, Stress, Sleep, Anxiety
- Being tested
- Moodlifters, Physical Activity, Nature Experiences
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoodliftersBehavioural
Mood Lifters, a novel mental wellness program, was developed as a more accessible means to provide psychotherapy (Votta \& Deldin, 2022). Meetings covered biopsychosocial areas and skills that were drawn from multiple therapeutic interventions consistent with a biopsychosocial framework. Areas included physical health, negative thoughts, problem-solving, emotional awareness and regulation, building relationships, behavioral activation, and using a strengths-based approach. ML is delivered by peer leaders who are individuals that have completed the program as well as a training program.
Physical ActivityBehavioural
Participants randomized to the exercise arm received 14 weeks of a structured weekly strength and conditioning training program to enhance muscle mass, strength, cardiorespiratory fitness, and overall well-being. The program is based on previous research showing that cardiorespiratory fitness and muscle strength/size can both contribute to decreased mortality/increased longevity and enhanced mental health (Burke et al., 2017; McLeod et al., 2016; Srikanthan \& Karlamangla, 2014; Strasser \& Burtscher, 2018). The training program consists of three training sessions per week, with one being an in-person group session guided by a certified strength and conditioning specialist. The other two training sessions are self-guided via the mobile app Trainheroic. This weekly training schedule aligns with previous research showing benefits to structuring an exercise program using a variety of social contexts (group setting, own, etc.; Burke et al., 2017).
Nature ExperiencesBehavioural
Participants randomized to the Nature Experiences participated in 14 weeks of group and self-directed activities to connect with the natural environment. Weekly group activities will be led by Nature Guides, who are undergraduate and graduate students with extensive outdoor education training. Group activities will last one hour a week and include hiking in forests, walking in parks, bird-watching, mindfulness exercises, and snow activities. Participants will be given a list of self-directed activity suggestions each week. The goal of self-directed activities is to spend an additional two hours in a natural environment each week.
| Study group | Role | What they receive |
|---|---|---|
| group-based therapy | Experimental | Group therapy delivered via moodlifters Receives: Behavioral: Moodlifters |
| physical activity | Experimental | Physical Activity and Exercise Receives: Behavioral: Physical Activity |
| nature experience | Experimental | Nature Experiences Receives: Behavioral: Nature Experiences |
| self-monitoring | No intervention | Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression as measured by Depression, Anxiety, Stress Survey - 21 (Depression subscale)
Self Reported Depression
Measured: Change in depression scores from time of randomization through 5 months
Anxiety as measured by Depression, Anxiety, Stress Survey - 21 (Anxiety subscale)
Self ReportedAnxiety
Measured: Change in anxiety scores from time of randomization through 5 months
Stress as measured by Depression, Anxiety, Stress Survey - 21 (Stress subscale)
Self Reported Stress
Measured: Change in stress scores from time of randomization through 5 months
Well-Being as measured by Warwick-Edinburgh Mental Well-being Scale
Self Reported well-being
Measured: Change in well-being scores from time of randomization through 5 months
Stress as measured by the Perceived Stress Scale
Self Reported subclinical stress
Measured: Change in stress scores from time of randomization through 5 months
Secondary outcomes (3)
Sleep Quality Index
Self Reported Sleep
Measured: Change in sleep quality scores from time of randomization through 5 months
Oura Ring Sleep Index
Biometric Sleep recorded from an Oura Ring
Measured: Change in Oura Sleep measured scores from time of randomization through 5 months
Medical Outcomes Social Support Survey
Social Support
Measured: Change in social support scores scores from time of randomization through 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Dec 2022
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- MassMutual - Private Industry Funded
- Responsible party
- Principal investigator, Matthew Price, University of Vermont
- Investigators
- Laura Bloomfield, MD, PhD, Principal investigator, University of VermontChris Danforth, PhD, Principal investigator, University of VermontRyan McGinnis, PhD, Principal investigator, University of VermontEllen McGinnis, PhD, Principal investigator, University of VermontMatthew Price, PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841979
- Sponsor's protocol ID
- LEMURS S23
- Acronym
- LEMURS-P
- Status last verified
- Mar 2024
- First submitted
- 6 Apr 2023
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Price M, Hidalgo JE, Bird YM, Bloomfield LSP, Buck C, Cerutti J, Dodds PS, Fudolig MI, Gehman R, Hickok M, Kim J, Llorin J, Lovato J, McGinnis EW, McGinnis RS, Norton R, Ramirez V, Stanton K, Ricketts TH, Danforth CM. A large clinical trial to improve well-being during the transition to college using wearables: The lived experiences measured using rings study. Contemp Clin Trials. 2023 Oct;133:107338. doi: 10.1016/j.cct.2023.107338. Epub 2023 Sep 16.
PubMed 37722484
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lived Experiences Measured Using Rings Pilot Study
- ClinicalTrials.gov ID
- NCT05841979
- Acronym / sponsor ID
- LEMURS-P / LEMURS S23
- Conditions
- Depression, Stress, Sleep, Anxiety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- MassMutual - Private Industry Funded
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 3 May 2023 (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.
The transition to college is a period of elevated risk for a range of mental health conditions. For students with pre-existing mental health diagnoses, the added pressures can exacerbate challenges. Although colleges and universities strive to provide mental health support to their students, the high demand for these services makes it difficult to provide scalable cost-effective solutions. To address these issues, the present study aims to compare the efficacy of three different treatments using a large cohort of 600 students transitioning to college. Interventions were selected based on their potential for generalizability and cost-effectiveness on college campuses. The randomized controlled trial will assign 150 participants to one of four arms: 1) group-based therapy, 2) physical activity program, 3) nature experiences group, or 4) self-monitoring condition as the control group. In addition, biometric data will be collected from all participants using a wearable device to develop algorithmic predictions of mental and physical health functioning. Once recruitment is complete, modeling strategies will be used to evaluate the outcomes and effectiveness of each intervention. The findings of this study will provide evidence as to the benefits of implementing scalable and proactive interventions using technology with the goal of improving well-being and success of new college students.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group-based therapy | Experimental | Behavioral: MoodliftersGroup therapy delivered via moodlifters |
| physical activity | Experimental | Behavioral: Physical ActivityPhysical Activity and Exercise |
| nature experience | Experimental | Behavioral: Nature ExperiencesNature Experiences |
| self-monitoring | No intervention | –Placebo control |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Current undergraduate student in their first year of school
- own a mobile device
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| MoodliftersMood Lifters, a novel mental wellness program, was developed as a more accessible means to provide psychotherapy (Votta \& Deldin, 2022). Meetings covered biopsychosocial areas and skills that were drawn from multiple therapeutic interventions consistent with a biopsychosocial framework. Areas included physical health, negative thoughts, problem-solving, emotional awareness and regulation, building relationships, behavioral activation, and using a strengths-based approach. ML is delivered by peer leaders who are individuals that have completed the program as well as a training program. | Behavioural | group-based therapy |
| Physical ActivityParticipants randomized to the exercise arm received 14 weeks of a structured weekly strength and conditioning training program to enhance muscle mass, strength, cardiorespiratory fitness, and overall well-being. The program is based on previous research showing that cardiorespiratory fitness and muscle strength/size can both contribute to decreased mortality/increased longevity and enhanced mental health (Burke et al., 2017; McLeod et al., 2016; Srikanthan \& Karlamangla, 2014; Strasser \& Burtscher, 2018). The training program consists of three training sessions per week, with one being an in-person group session guided by a certified strength and conditioning specialist. The other two training sessions are self-guided via the mobile app Trainheroic. This weekly training schedule aligns with previous research showing benefits to structuring an exercise program using a variety of social contexts (group setting, own, etc.; Burke et al., 2017). | Behavioural | physical activity |
| Nature ExperiencesParticipants randomized to the Nature Experiences participated in 14 weeks of group and self-directed activities to connect with the natural environment. Weekly group activities will be led by Nature Guides, who are undergraduate and graduate students with extensive outdoor education training. Group activities will last one hour a week and include hiking in forests, walking in parks, bird-watching, mindfulness exercises, and snow activities. Participants will be given a list of self-directed activity suggestions each week. The goal of self-directed activities is to spend an additional two hours in a natural environment each week. | Behavioural | nature experience |
Primary outcome
Depression as measured by Depression, Anxiety, Stress Survey - 21 (Depression subscale)
Time frame: Change in depression scores from time of randomization through 5 months
Self Reported Depression
Anxiety as measured by Depression, Anxiety, Stress Survey - 21 (Anxiety subscale)
Time frame: Change in anxiety scores from time of randomization through 5 months
Self ReportedAnxiety
Stress as measured by Depression, Anxiety, Stress Survey - 21 (Stress subscale)
Time frame: Change in stress scores from time of randomization through 5 months
Self Reported Stress
Well-Being as measured by Warwick-Edinburgh Mental Well-being Scale
Time frame: Change in well-being scores from time of randomization through 5 months
Self Reported well-being
Stress as measured by the Perceived Stress Scale
Time frame: Change in stress scores from time of randomization through 5 months
Self Reported subclinical stress
3 secondary outcomes
Sleep Quality Index
Time frame: Change in sleep quality scores from time of randomization through 5 months
Oura Ring Sleep Index
Time frame: Change in Oura Sleep measured scores from time of randomization through 5 months
Medical Outcomes Social Support Survey
Time frame: Change in social support scores scores from time of randomization through 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Derived from this study: PubMed 37722484Price M, Hidalgo JE, Bird YM, Bloomfield LSP, Buck C, Cerutti J, Dodds PS, Fudolig MI, Gehman R, Hickok M, Kim J, Llorin J, Lovato J, McGinnis EW, McGinnis RS, Norton R, Ramirez V, Stanton K, Ricketts TH, Danforth CM. A large clinical trial to improve well-being during the transition to college using wearables: The lived experiences measured using rings study. Contemp Clin Trials. 2023 Oct;133:107338. doi: 10.1016/j.cct.2023.107338. Epub 2023 Sep 16.
- Individual participant dataSharing planned: No
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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.
Laura Bloomfield, MD, PhD principal investigator
University of Vermont
Chris Danforth, PhD principal investigator
University of Vermont
Ryan McGinnis, PhD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Moodlifters, Physical Activity and Nature Experiences in people with Depression and Stress, run by University of Vermont at 1 site 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Depression as measured by Depression, Anxiety, Stress Survey - 21 (Depression subscale) (time frame: Change in depression scores from time of randomization through 5 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05841979, which also lists 1 linked publication.
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 17 Apr 2025; AzTrials last refreshed its copy on 4 Nov 2026.