NCT05684120

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2025

Completed
Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

2.2 years

First QC Date

January 4, 2023

Last Update Submit

December 3, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Patient Health Questionnaire - 9

    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

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

    through study completion, an average of 1 year

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Behavioral: Mood Lifters for Undergraduates

Waitlist Control Group

NO 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.

Interventions

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.

Also known as: Mood Lifters for College Students
Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergraduate students
  • at least 18 years of age

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48103, United States

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersMood Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Patricia J Deldin, Ph.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Waitlist control model
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 4, 2023

First Posted

January 13, 2023

Study Start

August 1, 2023

Primary Completion

October 18, 2025

Study Completion

October 18, 2025

Last Updated

December 10, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations