DepressionML-UPNCT05684120
Mood Lifters for Undergraduates
A study testing Mood Lifters for Undergraduates in people with Depression and Anxiety, run by University of Michigan at 1 site in United States.
Trial summary
Large-scale, effective, low-cost, and evidence-based programs that can nimbly translate new research discoveries into prevention and care for psychosocial-based problems are urgently needed since the vast majority of people who need evidence-based care do not receive it. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Mood Disorders
- What is being tested?
- Mood Lifters for Undergraduates
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 18 Oct 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- undergraduate students
- at least 18 years of age
Who cannot join
- active suicidal thoughts or behavior
- active psychosis
- borderline personality disorder
- active mania
- unwillingness to attend all sessions or treatment types (e.g., unwillingness to attend remote)
- non-undergraduate students.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mood Lifters for Undergraduates Project
Large-scale, effective, low-cost, and evidence-based programs that can nimbly translate new research discoveries into prevention and care for psychosocial-based problems are urgently needed since the vast majority of people who need evidence-based care do not receive it.
The purpose of this randomized control trial is to investigate the feasibility and efficacy of a Mood Lifters group template specifically for undergraduate students. Mood Lifters is an effective peer-led program that improves or maintains mental health. It seeks to help people enhance pleasure, engagement, and meaning in their lives while minimizing depression, fear, loneliness, and other negative feelings via a proprietary peer-based program that offers weekly meetings and other flexible support options. One obstacle to providing mental health care in the US is that it is costly to provide one-on-one therapy by a licensed professional. This is particularly true in large group settings with limited resources (counseling centers) and a large need for mental health care, like universities.
- Conditions
- Depression, Anxiety, Mood Disorders, Mental Health Wellness 1, Stress
- Being tested
- Mood Lifters for Undergraduates
- Medical subject headings
- Depression, Anxiety Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mood Lifters for UndergraduatesBehavioural
Also called Mood Lifters for College Students
Participants will need to attend 14 hour-long virtual weekly meetings on Zoom that focus on helpful mental health strategies and skills. Participants will be encourage to practice what they learn at home in order to improve their mood or mental wellness.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Individuals in this arm will take part in the Mood Lifters program immediately after recruitment. Receives: Behavioral: Mood Lifters for Undergraduates |
| Waitlist Control Group | No intervention | Individuals in this arm will be invited to take part in the Mood Lifters program after they complete post-treatment surveys as part of the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire - 9
Assesses Depressive Symptoms (Range 0-27; higher scores indicate more significant symptoms of depression)
Measured: through study completion, an average of 1 year
Generalized Anxiety Disorder - 7
Assesses Anxiety Symptoms (Range 0-21; higher scores indicate more significant symptoms of anxiety)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start1 Aug 2023
- Primary completion18 Oct 2025
- Study completion18 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Model description
- Waitlist control model
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Deldin, University of Michigan
- Investigators
- Patricia J Deldin, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684120
- Sponsor's protocol ID
- HUM00221612
- Acronym
- ML-UP
- Status last verified
- Dec 2025
- First submitted
- 4 Jan 2023
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mood Lifters for Undergraduates Project
- ClinicalTrials.gov ID
- NCT05684120
- Acronym / sponsor ID
- ML-UP / HUM00221612
- Conditions
- Depression, Anxiety, Mood Disorders, Mental Health Wellness 1, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 18 Oct 2025 (actual)
- Study completion
- 18 Oct 2025 (actual)
- First posted
- 13 Jan 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.
Large-scale, effective, low-cost, and evidence-based programs that can nimbly translate new research discoveries into prevention and care for psychosocial-based problems are urgently needed since the vast majority of people who need evidence-based care do not receive it.
The purpose of this randomized control trial is to investigate the feasibility and efficacy of a Mood Lifters group template specifically for undergraduate students. Mood Lifters is an effective peer-led program that improves or maintains mental health. It seeks to help people enhance pleasure, engagement, and meaning in their lives while minimizing depression, fear, loneliness, and other negative feelings via a proprietary peer-based program that offers weekly meetings and other flexible support options. One obstacle to providing mental health care in the US is that it is costly to provide one-on-one therapy by a licensed professional. This is particularly true in large group settings with limited resources (counseling centers) and a large need for mental health care, like universities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Waitlist control model
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Mood Lifters for UndergraduatesIndividuals in this arm will take part in the Mood Lifters program immediately after recruitment. |
| Waitlist Control Group | No intervention | –Individuals in this arm will be invited to take part in the Mood Lifters program after they complete post-treatment surveys as part of the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- undergraduate students
- at least 18 years of age
Key exclusion criteria (6 listed)
- active suicidal thoughts or behavior
- active psychosis
- borderline personality disorder
- active mania
- unwillingness to attend all sessions or treatment types (e.g., unwillingness to attend remote)
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 |
|---|---|---|
| Mood Lifters for UndergraduatesAlso: Mood Lifters for College StudentsParticipants will need to attend 14 hour-long virtual weekly meetings on Zoom that focus on helpful mental health strategies and skills. Participants will be encourage to practice what they learn at home in order to improve their mood or mental wellness. | Behavioural | Treatment Group |
Primary outcome
Patient Health Questionnaire - 9
Time frame: through study completion, an average of 1 year
Assesses Depressive Symptoms (Range 0-27; higher scores indicate more significant symptoms of depression)
Generalized Anxiety Disorder - 7
Time frame: through study completion, an average of 1 year
Assesses Anxiety Symptoms (Range 0-21; higher scores indicate more significant symptoms of anxiety)
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 10 Dec 2025.
- 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.
Patricia J Deldin, Ph.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mood Lifters for Undergraduates in people with Depression and Anxiety, run by University of Michigan 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 6 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 10 Dec 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.
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?
Patient Health Questionnaire - 9 (time frame: through study completion, an average of 1 year). The study lists 2 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 10 Dec 2025.