Mood Lifters for Undergraduates (ML-UP)

August 2, 2023 updated by: Elena Pokowitz, University of Michigan

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • Recruiting
        • University of Michigan
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion:

  • undergraduate students
  • at least 18 years of age

Exclusion criteria include:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Individuals in this arm will take part in the Mood Lifters program immediately after recruitment.
Behavioral: Mood Lifters for Undergraduates
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.
Other Names:
  • Mood Lifters for College Students
No Intervention: Waitlist Control Group
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
through study completion, an average of 1 year
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)
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Elena L Pokowitz, M.Ed., University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 4, 2023

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Actual)

January 13, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00221612

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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