Tassone Vanessa K, Quesnel Danika A, Parkington Karisa, Rueda Alice, Martin Josh, Lee Gyu Hee, Teixeira Alyssa, deJonge Melissa L, Lou Wendy, Wiljer David, Mulsant Benoit H, Sabiston Catherine M, Bhat Venkat
Interventional Psychiatry Program, St. Michael's Hospital, Toronto, Ontario, Canada.
Institute of Medical Science, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
PLoS One. 2025 Sep 2;20(9):e0330848. doi: 10.1371/journal.pone.0330848. eCollection 2025.
At least 30% of individuals with major depressive disorder do not respond to conventional treatments (i.e., they meet the criteria for treatment-resistant depression [TRD]). Alternative therapeutic modalities are needed. Some studies have reported that physical activity (PA) programs can improve depressed mood and reduce depressive symptoms. However, few studies to date have examined the effects of PA as an adjunct to standard treatment for TRD. The MoveU.HappyU PA program has been shown to improve depressive symptoms in university students. Before a definitive trial testing MoveU.HappyU in TRD can be designed, pilot data is needed.
The current study is a single-site, pilot, two-arm randomized controlled trial. It will investigate the feasibility of randomizing 30 adult participants with TRD to: (1) a remotely delivered four-week MoveU.HappyU adjunct to treatment as usual (TAU), or (2) TAU. Acceptability of the PA program will also be assessed. Participants randomized to the PA program will meet weekly with a program trainer to engage in PA counselling and structured PA. They will also be instructed to independently complete 120 minutes of PA per week. The four-week intervention period will be followed by six weeks of observation. Throughout the study, both groups will receive the same digital monitoring via self-report questionnaires and a wearable device, as well as traditional monitoring (i.e., clinical assessments administered by a masked rater).
This pilot study will assess the feasibility of a trial implementing MoveU.HappyU for TRD and generate clinical parameter estimates for larger studies. This line of research highlights the importance of PA programs that integrate personalized PA with PA counselling. It will also influence the development of interventions that are more tailored and effective.
ClinicalTrials.gov NCT06404320.
至少30%的重度抑郁症患者对传统治疗无反应（即他们符合难治性抑郁症[TRD]的标准）。需要替代治疗方式。一些研究报告称，体育活动（PA）项目可以改善抑郁情绪并减轻抑郁症状。然而，迄今为止，很少有研究考察PA作为TRD标准治疗辅助手段的效果。MoveU.HappyU PA项目已被证明可改善大学生的抑郁症状。在设计针对TRD的MoveU.HappyU确定性试验之前，需要先导数据。
本研究是一项单中心、先导性、双臂随机对照试验。它将调查将30名成年TRD患者随机分为两组的可行性：（1）在常规治疗（TAU）基础上远程提供为期四周的MoveU.HappyU辅助治疗，或（2）TAU。还将评估PA项目的可接受性。随机分配到PA项目的参与者将每周与项目培训师会面，接受PA咨询和结构化PA。他们还将被指示每周独立完成120分钟的PA。四周的干预期之后将进行六周的观察。在整个研究过程中，两组将通过自我报告问卷和可穿戴设备接受相同的数字监测，以及传统监测（即由盲法评分者进行的临床评估）。
这项先导研究将评估对TRD实施MoveU.HappyU试验的可行性，并为更大规模的研究生成临床参数估计值。这一系列研究突出了将个性化PA与PA咨询相结合的PA项目的重要性。它还将影响更具针对性和有效性的干预措施的开发。
ClinicalTrials.gov NCT06404320。
