RESISTance Exercise for Depression Trial
Recruiting · NCT06110897 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Wisconsin, Madison
View the official record on ClinicalTrials.gov →Interventions studied
High Dose Resistance Exercise TrainingLow Dose Resistance Exercise Training Group
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion 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
Exclusion criteria
- 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
Where it is running
2 locations listed across 2 US states.
- Iowa State University - Ames, Iowa, United States
- University of Wisconsin - Madison - Madison, Wisconsin, United States