RECRUITING

RESISTance Exercise for Depression Trial

Conditions

Major Depressive Disorder Resistance Exercise Training Strength Training

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Depression is a leading cause of disability worldwide and current treatments are ineffective for many people. This trial will investigate the efficacy of a 16-week high vs low dose resistance exercise training program for the treatment of Major Depressive Disorder (MDD) in 200 adults.

Official Title

Resistance Exercise to Treat Major Depression Via Cerebrovascular Mechanisms: Confirming Efficacy and Informing Precision Medicine

Quick Facts

Study Start:2024-01-01

Study Completion:2028-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06110897

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.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Be diagnosed with DSM-5 MDD, confirmed via Structured Clinical Interview for DSM-5 (SCID). * Have current depressive symptoms of at least mild severity defined by the Hamilton Rating Scale of Depression 17 greater than or equal to 8 (HAMD; using the GRID-HAMD evaluated by trained, masked raters) * Be ages 18-65 * EITHER not taking any mental health medications or seeking other mental health treatment (e.g., behavioral, psychological) OR be on a stable mental health medication and/or treatment regimen for the past 8 weeks, and intend to maintain that regimen for the duration of the study * Safe to exercise based on physical activity screening questions or physician clearance * Willing to be randomized to either condition * have a Smartphone	* Currently pregnant, nursing, or planning to become pregnant during the trial * Class III+ obesity * Diagnosed with lifetime or current Psychosis, Mania, or Bipolar Disorder, via the SCID * Diagnosed with current Substance Use Disorder, via the SCID * Active suicidal ideation with specific plan and intent ('5' score on Suicidal Ideation from Columbia Suicide Severity Rating Scale), which would necessitate immediate emergent care * Exhibit behavioral disturbance (e.g., aggression, mild-moderate cognitive impairment) that would significantly interfere with study participation, as assessed by clinical research personnel * Currently meets resistance exercise recommendations (2 days per week) for the last 8 weeks * Self-reporting a concussion/traumatic brain injury within the last 3 months * Having cardiovascular disease, uncontrolled hypertension, or uncontrolled diabetes

Inclusion Criteria

Exclusion Criteria

* Be diagnosed with DSM-5 MDD, confirmed via Structured Clinical Interview for DSM-5 (SCID).
* Have current depressive symptoms of at least mild severity defined by the Hamilton Rating Scale of Depression 17 greater than or equal to 8 (HAMD; using the GRID-HAMD evaluated by trained, masked raters)
* Be ages 18-65
* EITHER not taking any mental health medications or seeking other mental health treatment (e.g., behavioral, psychological) OR be on a stable mental health medication and/or treatment regimen for the past 8 weeks, and intend to maintain that regimen for the duration of the study
* Safe to exercise based on physical activity screening questions or physician clearance
* Willing to be randomized to either condition
* have a Smartphone

* Currently pregnant, nursing, or planning to become pregnant during the trial
* Class III+ obesity
* Diagnosed with lifetime or current Psychosis, Mania, or Bipolar Disorder, via the SCID
* Diagnosed with current Substance Use Disorder, via the SCID
* Active suicidal ideation with specific plan and intent ('5' score on Suicidal Ideation from Columbia Suicide Severity Rating Scale), which would necessitate immediate emergent care
* Exhibit behavioral disturbance (e.g., aggression, mild-moderate cognitive impairment) that would significantly interfere with study participation, as assessed by clinical research personnel
* Currently meets resistance exercise recommendations (2 days per week) for the last 8 weeks
* Self-reporting a concussion/traumatic brain injury within the last 3 months
* Having cardiovascular disease, uncontrolled hypertension, or uncontrolled diabetes

Contacts and Locations

Study Contact

Taline Jouzi

CONTACT

608-890-0154

jouzi@wisc.edu

Jeni Lansing

CONTACT

jlansing3@wisc.edu

Principal Investigator

Jacob Meyer, PhD

PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Study Locations (Sites)

Iowa State University

Ames, Iowa, 50010

United States

University of Wisconsin - Madison

Madison, Wisconsin, 53705

United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

Jacob Meyer, PhD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

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 Registration Dates

Study Start Date2024-01-01

Study Completion Date2028-05-31

Study Record Updates

Study Start Date2024-01-01

Study Completion Date2028-05-31

Terms related to this study

Keywords Provided by Researchers

Resistance Exercise Training
Strength Training

Additional Relevant MeSH Terms

Major Depressive Disorder