Clinical trial NCT06110897: RESISTance Exercise for Depression Trial
Official title: Resistance Exercise to Treat Major Depression Via Cerebrovascular Mechanisms: Confirming Efficacy and Informing Precision Medicine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Resistance Exercise Training
Strength Training
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Iowa State University
name: University of Minnesota
name: University of Limerick
First posted: 2023-11-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Frontline treatments for major depressive disorder (MDD), including psycho- and pharmacotherapy, have limited effectiveness, and there is a critical need to develop and test novel, efficacious treatments for MDD and simultaneously work to optimize its benefits. Resistance exercise training (RET) is a promising but understudied treatment approach. This trial will investigate the efficacy of RET for treatment of MDD in a 1:1 randomized controlled trial (n=200) of 16 weeks of high vs low progressive RET in adults with DSM-5 diagnosed MDD. Further, this project will explore potential mechanisms leading to symptom improvement, including changes in cerebrovascular function (i.e., cerebral blood velocity and pulsatility) and self-efficacy, while also using supervised machine learning tools to predict depression changes, cerebrovascular changes, and participant adherence. Upon completion, this study will build towards identifying and translating mechanistically driven behavioral treatments to reduce the global burden of mental illness.

Eligibility criteria: 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

Primary outcomes:
measure: Change in depressive symptom severity measured by GRID Hamilton Depression Rating Scale (GRID-HAM-D)
timeFrame: Weeks 0, 8, 16, 26, 52
measure: Change in self-reported depression symptom severity measured by Quick Inventory of Depressive Symptoms (QIDS)
timeFrame: Weeks 0, 1-16 (once per week across the intervention), 26, 52
measure: Cerebral mean blood velocity
timeFrame: Weeks 0, 8, 16, 26, 52
measure: Cerebral blood velocity pulsatility
timeFrame: Weeks 0, 8, 16, 26, 52
Secondary outcomes:
measure: Changes in general self efficacy measured by New General Self-Efficacy Scale
timeFrame: Weeks 0, 8, 16, 26, 52
measure: Changes in RET-specific self efficacy measured by a modified version of the New General Self-Efficacy Scale
timeFrame: Weeks 0, 1-16 (once per week across the intervention), 26, 52
measure: Change in suicidal thoughts measured by Columbia-Suicide Severity Rating Scale (CSSRS)
timeFrame: Weeks 0, 8, 16, 26, 52
measure: Change in muscular strength measured by Estimated 1 Repetition Maximum (RM) Strength Test
timeFrame: Weeks 0, 8, 16, 26, 52
measure: Change in grip strength
timeFrame: Weeks 0, 8, 16, 26, 52
measure: Global cerebral blood flow
timeFrame: Weeks 0, 8, 16, 26, 52
measure: Brachial blood pressure
timeFrame: Weeks 0, 8, 16, 26, 52
measure: Carotid blood pressure
timeFrame: Weeks 0, 8, 16, 26, 52
measure: Aortic stiffness
timeFrame: Weeks 0, 8, 16, 26, 52
measure: Carotid stiffness
timeFrame: Weeks 0, 8, 16, 26, 52
measure: End-tidal Carbon Dioxide (CO2)
timeFrame: Weeks 0, 8, 16, 26, 52
measure: Cerebrovascular reactivity to breath holds
timeFrame: Weeks 0, 8, 16, 26, 52
measure: Heart Rate (HRV)
timeFrame: Weeks 0, 8, 16, 26, 52
measure: Blood Pressure Variability (BPV)
timeFrame: Weeks 0, 8, 16, 26, 52
measure: Change in quality of life measured by 36-Item Short Form Health Survey (SF-36)
timeFrame: Weeks 0, 8, 16, 26, 52
measure: Change in worry measured by Penn State Worry Questionnaire (PSWQ)
timeFrame: Weeks 0, 8, 16, 26, 52
measure: Change in stress measured by Perceived Stress Scale (PSS-10)
timeFrame: Weeks 0, 8, 16, 26, 52
measure: Change in sleep measured by Insomnia Severity Index (ISI)
timeFrame: Weeks 0, 8, 16, 26, 52
measure: Change in cognitive function measured by PROMIS-Cognitive Function SF (PROMIS)
timeFrame: Weeks 0, 8, 16, 26, 52
measure: Change in emotional regulation measured by Emotional Regulation Questionnaire (ERQ)
timeFrame: Weeks 0, 8, 16, 26, 52
measure: Average self-reported level of symptom improvement measured by Patient Global Impression of Change (PGIC)
timeFrame: Weeks 16, 26, and 52
measure: Change in exercise habits
timeFrame: Weeks 0, 1-16 (once per week across the intervention), 26, 52
measure: Change in exercise identity and intrinsic motivation
timeFrame: Weeks 0, 1-16 (once per week across the intervention), 26, 52
measure: Change in self-reported physical activity measured by International Physical Activity Questionnaire (IPAQ)
timeFrame: Weeks 0, 8, 16, 26, 52
measure: Change in monitor-assessed physical activity measured by accelerometry
timeFrame: Weeks 0, 8, 16, 26, 52 (worn 1 week following week 0 and 1 week after all other timepoints)
Other outcomes:
measure: Major depressive disorder diagnosis assessed using Structured Clinical Interview for DSM-5 Disorders (SCID)
timeFrame: Weeks 0, 8, 16, 26, 52
Locations:
city: Ames
country: United States
facility: Iowa State University
state: Iowa
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Jacob Meyer, PhD
role: PRINCIPAL_INVESTIGATOR
References: