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ML-UP: Mood Lifters for Undergraduates

Sponsor
University of Michigan (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05684120
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
16
Anticipated Duration (Months)
9.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mood Lifters for Undergraduates
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Waitlist control modelWaitlist control model
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Mood Lifters for Undergraduates Project
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Patient Health Questionnaire - 9 [through study completion, an average of 1 year]

      Assesses Depressive Symptoms (Range 0-27; higher scores indicate more significant symptoms of depression)

    2. Generalized Anxiety Disorder - 7 [through study completion, an average of 1 year]

      Assesses Anxiety Symptoms (Range 0-21; higher scores indicate more significant symptoms of anxiety)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Michigan Ann Arbor Michigan United States 48103

    Sponsors and Collaborators

    • University of Michigan

    Investigators

    • Principal Investigator: Patricia J Deldin, Ph.D., University of Michigan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Patricia Deldin, Professor of Psychology, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT05684120
    Other Study ID Numbers:
    • HUM00221612
    First Posted:
    Jan 13, 2023
    Last Update Posted:
    Jan 31, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Mood Disorders

    Study Results

    No Results Posted as of Jan 31, 2023