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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05684120
Other study ID # HUM00221612
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date December 2025

Study information

Verified date June 2024
Source University of Michigan
Contact Elena L Pokowitz, M.Ed.
Phone 919-948-0362
Email moodliftersundergrad@umich.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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