RESISTance Exercise for Depression Trial

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое High Dose Resistance Exercise Training
  Progressive resistance exercise training
• Поведенческое Low Dose Resistance Exercise Training Group
  Progressive resistance exercise training

Первичные конечные точки

• Change in depressive symptom severity measured by GRID Hamilton Depression Rating Scale (GRID-HAM-D) [Срок оценки: Weeks 0, 8, 16, 26, 52]
• Change in self-reported depression symptom severity measured by Quick Inventory of Depressive Symptoms (QIDS) [Срок оценки: Weeks 0, 1-16 (once per week across the intervention), 26, 52]
• Cerebral mean blood velocity [Срок оценки: Weeks 0, 8, 16, 26, 52]
• Cerebral blood velocity pulsatility [Срок оценки: Weeks 0, 8, 16, 26, 52]

Вторичные конечные точки (12)

• Changes in general self efficacy measured by New General Self-Efficacy Scale [Срок оценки: Weeks 0, 8, 16, 26, 52]
• Changes in RET-specific self efficacy measured by a modified version of the New General Self-Efficacy Scale [Срок оценки: Weeks 0, 1-16 (once per week across the intervention), 26, 52]
• Change in suicidal thoughts measured by Columbia-Suicide Severity Rating Scale (CSSRS) [Срок оценки: Weeks 0, 8, 16, 26, 52]
• Change in muscular strength measured by Estimated 1 Repetition Maximum (RM) Strength Test [Срок оценки: Weeks 0, 8, 16, 26, 52]
• Change in grip strength [Срок оценки: Weeks 0, 8, 16, 26, 52]
• Global cerebral blood flow [Срок оценки: Weeks 0, 8, 16, 26, 52]
• Brachial blood pressure [Срок оценки: Weeks 0, 8, 16, 26, 52]
• Carotid blood pressure [Срок оценки: Weeks 0, 8, 16, 26, 52]
• Aortic stiffness [Срок оценки: Weeks 0, 8, 16, 26, 52]
• Carotid stiffness [Срок оценки: Weeks 0, 8, 16, 26, 52]
• End-tidal Carbon Dioxide (CO2) [Срок оценки: Weeks 0, 8, 16, 26, 52]
• Cerebrovascular reactivity to breath holds [Срок оценки: Weeks 0, 8, 16, 26, 52]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Iowa State University — Ames
• University of Wisconsin - Madison — Madison

Публикации

• Meyer JD, Smith SL, Gidley JM, Molina A, Churchill SL, Kelly SJE, Lansing JE, Wade NG, Phillips AL, Liu P, Herring MP, Murray TA, Barnes JN, Goldberg SB, Lefferts WK. Protocol for a randomized controlled trial of a resistance exercise training to treat major depression via cerebrovascular mechanisms (RESIST Trial). Trials. 2025 Aug 26;26(1):306. doi: 10.1186/s13063-025-09025-z. PMID 40859378

Идентификаторы

NCT: NCT06110897 · 2025-0295 · 1R01MH130566-01A1 · Protocol Version 9/15/2025 · A176000 · EDUC/KINESIOLOGY

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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