Mental Health Support Program for Depression and Anxiety

(ML-UP Trial)

Overseen By Patricia J Deldin, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Suicidal thoughts, Psychosis, Borderline, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Mood Lifters for Undergraduates, designed to support mental health in undergraduate students dealing with depression and anxiety. The program offers a peer-led approach with weekly meetings and flexible support, aiming to boost happiness and reduce negative emotions like fear and loneliness. The trial compares students who start the program immediately with those who join later to assess its effectiveness. Undergraduate students who struggle with depression or anxiety and are open to attending all program sessions might be a good fit for this trial. As an unphased trial, this study provides a unique opportunity for students to actively contribute to mental health research while potentially improving their own well-being.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Mood Lifters program is safe for undergraduate students?

Research has shown that the Mood Lifters program is safe and easy to use. In a study with graduate students and young adults, over 84% reported that the program helped them manage their mental health better. Most participants had a positive experience and did not encounter serious negative effects. The study also found improvements in depression, anxiety, and social interactions. These results support the program's safety and effectiveness for mental health support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mood Lifters program because it offers a fresh approach to managing depression and anxiety among undergraduates without relying on medication. While traditional treatments often include antidepressants or therapy sessions, Mood Lifters is a peer-led, group-based program that focuses on building positive habits and fostering social support. This innovative method empowers students to actively participate in their mental health journey, promoting long-lasting changes in their mood and well-being. By engaging students in a supportive community, Mood Lifters aims to address the mental health challenges in a more personal and accessible way.

What evidence suggests that the Mood Lifters program is effective for depression and anxiety?

Research has shown that the Mood Lifters program reduces depression, anxiety, and stress. In a study with graduate students, participants experienced significant improvements in these areas. In this trial, individuals in the Treatment Group will join the Mood Lifters program immediately after recruitment. Led by peers, the program emphasizes group support, making it affordable and accessible. This method has prevented anxiety from worsening and improved overall well-being among young adults. These results suggest that the program could also benefit undergraduate students. ^{1 2 4 6 7}

Who Is on the Research Team?

Patricia J Deldin, Ph.D.

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for undergraduate students who are at least 18 years old and interested in improving their mental health. It's not suitable for those with borderline personality disorder, active suicidal thoughts or behaviors, unwillingness to attend all sessions, non-undergraduates, or individuals experiencing active psychosis or mania.

Inclusion Criteria

I am currently an undergraduate student.

Exclusion Criteria

Active suicidal thoughts or behavior

Active psychosis

Borderline personality disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the experimental group take part in the Mood Lifters program immediately after recruitment, involving weekly meetings and flexible support options

12 weeks

12 visits (weekly meetings)

Waitlist Control

Participants in the control group complete post-treatment surveys before being invited to the Mood Lifters program

12 weeks

Follow-up

Participants are monitored for changes in depressive and anxiety symptoms through study completion

up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Mood Lifters for Undergraduates

Trial Overview The trial tests the 'Mood Lifters' program designed for undergrads to boost mental wellness. Participants will join peer-led groups aiming to reduce negative feelings like depression and anxiety while increasing pleasure and engagement through weekly meetings and support options.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

Individuals in this arm will take part in the Mood Lifters program immediately after recruitment.

Group II: Waitlist Control Group Active Control 1 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.

Mood Lifters for Undergraduates is already approved in United States for the following indications:

Approved in United States as Mood Lifters for:

• Mental health wellness
• Depression
• Anxiety
• Stress management

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

Tertiary students seeking help for severe mood disorders reported more severe depressive symptoms and higher rates of suicidal ideation compared to non-students, based on an analysis of 131 clients from the Youth Mood Clinic.

Over 21% of tertiary students in the study dropped out or deferred their studies during treatment, highlighting the need for targeted mental health support for students in higher education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and clinical needs of young tertiary students attending a specialist mood disorders clinic. O'Gorman, KM., Schmaal, L., Ratheesh, A., et al.[2023]

The Mood Lifters for Graduate Students (ML-GS) intervention significantly reduced depression, anxiety, and stress in a clinical trial with 131 participants, demonstrating its efficacy for this high-risk population.

Improvements in mental health were not only significant but also clinically meaningful, and these benefits were maintained one month after completing the program, indicating lasting effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment for graduate students: Blunting the emotional toll of postgraduate education. Prakash, N., Votta, CM., Deldin, PJ.[2023]

A brief, four-session resilience program for first-year college students showed significant improvements in perceived stress immediately after the program and in depression levels by the end of the semester, indicating its potential long-term benefits.

The program also enhanced skills in emotion regulation, mindfulness, and cognitive behavioral therapy (CBT), with CBT skills playing a key role in mediating the observed mental health improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pragmatic clinical trial examining the impact of a resilience program on college student mental health. Akeman, E., Kirlic, N., Clausen, AN., et al.[2022]

The Mood Disorder Clinic, established in 2004, aims to provide care for uninsured or underinsured patients while also training Family Medicine residents in diagnosing and treating mood disorders.

Feedback from resident physicians indicates that the clinic effectively enhances their psychiatric knowledge and skills, demonstrating the value of a team-based approach in primary care for mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a specialty clinic to teach a standardized approach to mood disorders in a family medicine residency. Kane, M., Manning, JS.[2015]

The Mood Mechanic course, an online psychological intervention for young adults aged 18-24, demonstrated significant reductions in symptoms of depression and anxiety in both a controlled research trial (192 participants) and a routine healthcare setting (222 participants), with large effect sizes (>1.0).

Both groups reported high levels of treatment satisfaction, indicating that online interventions can be effective and well-received by young adults, who often hesitate to seek traditional treatment for mood and anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered treatment for young adults with anxiety and depression: Evaluation in routine clinical care and comparison with research trial outcomes. Staples, LG., Dear, BF., Johnson, B., et al.[2020]

Approximately 19.9% of medical students experience mental disorders, with a notable increase in depressive symptoms among fifth-year students (24.4%) compared to first-year students (16.2%).

Russian-speaking students showed a higher prevalence of depression (26.8%) and suicide attempts (4.7%) compared to foreign students (17.1% and 1.6%, respectively), indicating a significant need for targeted mental health support for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Depression in medical students: prevalence, dynamics and comorbidity]. Ruzhenkova, VV., Khamskaya, IS., Gomelak, YN.[2022]

In a study of 1253 first-year university students, 13.3% experienced first-onset Major Depressive Episode and Generalized Anxiety Disorder (MDE-GAD) within a year, highlighting the prevalence of these conditions in this population.

Key predictors for first-onset and persistence of MDE-GAD included childhood emotional abuse, prior suicidal ideation, and previous symptoms of depression and anxiety, indicating that early identification and intervention could be crucial for at-risk students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive models for first-onset and persistence of depression and anxiety among university students. Ballester, L., Alayo, I., Vilagut, G., et al.[2022]

The study proposes a randomized controlled trial (RCT) to assess the feasibility of an online psychoeducational intervention called 'A Bite of ACT' aimed at reducing depression, anxiety, and stress among university students, highlighting the urgent need for low-cost mental health support.

The primary outcome will measure the feasibility of the trial design using the Acceptance Checklist for Clinical Effectiveness Pilot Trials (ACCEPT), while secondary outcomes will evaluate well-being, social connectedness, and psychological flexibility, providing a comprehensive assessment of the intervention's potential effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel ACT-based eHealth psychoeducational intervention for students with mental distress: a study protocol for a mixed-methodology pilot trial. Edwards, DJ., Rainey, E., Boukouvala, V., et al.[2020]

In a pilot project involving eight college health center teams, 69% of students receiving primary medical care were screened for depression, leading to the treatment and tracking of 801 depressed students over 12 weeks.

The implementation of the Chronic Care Model (CCM) for depression demonstrated effectiveness in improving the identification and management of depression among college students, achieving most of the targeted clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot for improving depression care on college campuses: results of the College Breakthrough Series-Depression (CBS-D) project. Chung, H., Klein, MC., Silverman, D., et al.[2012]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10968146/

Mood Lifters for Graduate Students and Young Adults Mood Lifters (ML) is a dimensional, group-based, peer-led mental health program that has shown efficacy in mitigating psychopathology and promoting wellness.

2. researchgate.net researchgate.net/publication/379131520_Mood_Lifters_for_Graduate_Students_and_Young_Adults_A_Mixed-Methods_Investigation_into_Mechanisms_of_Change_in_Online_Group_Therapy

(PDF) Mood Lifters for Graduate Students and Young Adults Conclusions: These findings suggest that ML-GS is effective in reducing depression, anxiety, and stress among graduate students. It may be a ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39566057/

Mood Lifters for graduate students: Preventing the ... The current study assesses the efficacy of ML-GS in preventing escalation of anxiety among graduate students during a clinical trial.

4. withpower.com withpower.com/trial/phase-mood-disorders-2023-6c57e

Mental Health Support Program for Depression and Anxiety The Mood Lifters for Graduate Students (ML-GS) intervention significantly reduced depression, anxiety, and stress in a clinical trial with 131 participants, ...

5. psycnet.apa.org psycnet.apa.org/doiLanding?doi=10.1037/ccp0000844

Treatment for graduate students: Blunting the emotional toll of ... Results: Results indicated that participants enrolled in ML-GS experienced significant, clinically meaningful reductions in depression, anxiety, ...

6. clinicaltrial.be clinicaltrial.be/en/details/188528?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Mood Lifters for Undergraduates Mood Lifters is an effective peer-led program that improves or maintains mental health. It seeks to help people enhance pleasure, engagement, ...

7. sites.lsa.umich.edu sites.lsa.umich.edu/pjdeldin-lab/wp-content/uploads/sites/928/2024/08/Mood-Lifters-for-college-athletes-a-biopsychosocial-approach-to-improving-mental-health-for-student-athletes.pdf

Mood Lifters for college athletes: a biopsychosocial ... Results: Mood Lifters significantly improved participants' depression, anxiety, and self-esteem. Conclusion: Student-athletes showed improvements in mental ...