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Mood Lifters for Undergraduates (ML-UP)

Primary Purpose

Depression, Anxiety, Mood Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mood Lifters for Undergraduates
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group

Waitlist Control Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Patient Health Questionnaire - 9
Assesses Depressive Symptoms (Range 0-27; higher scores indicate more significant symptoms of depression)
Generalized Anxiety Disorder - 7
Assesses Anxiety Symptoms (Range 0-21; higher scores indicate more significant symptoms of anxiety)

Secondary Outcome Measures

Full Information

First Posted
January 4, 2023
Last Updated
August 2, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05684120
Brief Title
Mood Lifters for Undergraduates
Acronym
ML-UP
Official Title
Mood Lifters for Undergraduates Project
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Mood Disorders, Mental Health Wellness 1, Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Waitlist control model
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Individuals in this arm will take part in the Mood Lifters program immediately after recruitment.
Arm Title
Waitlist Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mood Lifters for Undergraduates
Other Intervention Name(s)
Mood Lifters for College Students
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire - 9
Description
Assesses Depressive Symptoms (Range 0-27; higher scores indicate more significant symptoms of depression)
Time Frame
through study completion, an average of 1 year
Title
Generalized Anxiety Disorder - 7
Description
Assesses Anxiety Symptoms (Range 0-21; higher scores indicate more significant symptoms of anxiety)
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elena L Pokowitz, M.Ed.
Phone
919-948-0362
Email
moodliftersundergrad@umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia J Deldin, Ph.D.
Email
pjdeldin@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena L Pokowitz, M.Ed.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Deldin, Ph.D.
Phone
734-647-7550
Email
pjdeldin@umich.edu
First Name & Middle Initial & Last Name & Degree
Sandra Graham-Bermann, Ph.D.
Email
sandragb@umich.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mood Lifters for Undergraduates

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