150 Participants Needed

Mental Health Support Program for Depression and Anxiety

(ML-UP Trial)

EL
PJ
Overseen ByPatricia J Deldin, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Mood Lifters for depression and anxiety?

The Mood Lifters for Graduate Students program has been studied and shown to be effective in addressing mental health concerns among graduate students, who are at higher risk for these issues. Additionally, internet-delivered treatments like the Mood Mechanic course have been effective for young adults with depression and anxiety, suggesting that similar approaches may be beneficial.12345

How is the Mood Lifters treatment for depression and anxiety different from other treatments?

Mood Lifters is unique because it is specifically designed to meet the needs of undergraduate and graduate students, offering a tailored approach to mental health support in an academic setting. Unlike traditional treatments, it focuses on building resilience and is accessible to all students, addressing the high prevalence of depression and anxiety in this population.16789

Research Team

PJ

Patricia J Deldin, Ph.D.

Principal Investigator

University of Michigan

Eligibility Criteria

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.
I am 18 years old or older.

Exclusion Criteria

Active suicidal thoughts or behavior
Active psychosis
Borderline personality disorder
See 3 more

Timeline

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

Treatment Details

Interventions

  • Mood Lifters for Undergraduates
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment GroupExperimental Treatment1 Intervention
Individuals in this arm will take part in the Mood Lifters program immediately after recruitment.
Group II: Waitlist Control GroupActive Control1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

Findings from Research

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.
Treatment for graduate students: Blunting the emotional toll of postgraduate education.Prakash, N., Votta, CM., Deldin, PJ.[2023]
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.
Use of a specialty clinic to teach a standardized approach to mood disorders in a family medicine residency.Kane, M., Manning, JS.[2015]
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.
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]

References

Treatment for graduate students: Blunting the emotional toll of postgraduate education. [2023]
Use of a specialty clinic to teach a standardized approach to mood disorders in a family medicine residency. [2015]
A pilot for improving depression care on college campuses: results of the College Breakthrough Series-Depression (CBS-D) project. [2012]
Characteristics and clinical needs of young tertiary students attending a specialist mood disorders clinic. [2023]
Internet-delivered treatment for young adults with anxiety and depression: Evaluation in routine clinical care and comparison with research trial outcomes. [2020]
A pragmatic clinical trial examining the impact of a resilience program on college student mental health. [2022]
7.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Depression in medical students: prevalence, dynamics and comorbidity]. [2022]
Predictive models for first-onset and persistence of depression and anxiety among university students. [2022]
Novel ACT-based eHealth psychoeducational intervention for students with mental distress: a study protocol for a mixed-methodology pilot trial. [2020]