Remotely Delivered Physical Activity Program for Treatment-Resistant Depression: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility
研究概览
简要总结
This is a pilot study examining the delivery of a remotely delivered, one-on-one, individualized physical activity (PA) program in adult participants with treatment-resistant depression (TRD).
详细描述
More than one-third of patients with major depressive disorder will not respond to at least two antidepressant medication trials, meeting the criteria for TRD. As a result, alternative therapeutic modalities, such as PA, are garnering interest. Numerous studies have reported an association between PA and improvements in mood and mental health. The MoveU.HappyU PA program is an initiative that considers individuals' PA preferences and priorities and works collaboratively to develop individualized PA programs. The program has been found to improve depressive symptoms in a non-clinical sample of university students.
This is a single-site, pilot, randomized controlled clinical trial. The trial will evaluate the feasibility of randomizing adult participants with TRD to a remotely delivered one-on-one individualized PA program (MoveU.HappyU) in addition to treatment as usual (TAU) or TAU. The trial will also assess the acceptability of the PA program and collect data to monitor the efficacy of the PA program for depressive and anxiety symptoms as well as quality of life. This trial includes the use of a digital platform to evaluate the effect of the PA program on passive physiological data that are collected through the use of a wearable device.
Thirty participants will be randomized in a 2:1 allocation to one of two treatment arms: 1) TAU with a 4-week remotely delivered, one-on-one, individualized PA program add-on; 2) TAU without the PA program add-on. Participants in both arms will complete the same clinician-administered scales, self-reported mental health questionnaires, and use a wearable device. After the 4-week interventional period, participants will enter a 6-week observational follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sedentary adults (engage in less than 60 minutes of moderate-to-vigorous PA per week) between the ages of 18 and 65 years, inclusive, capable of giving informed consent.
- •Participants meeting diagnostic criteria for major depressive disorder without psychotic symptoms according to the Diagnostic and Statistical Manual of Mental Disorders - 5th Ed. and currently experiencing a major depressive episode (MDE) as confirmed by the Mini International Neuropsychiatric Interview (MINI).
- •A Montgomery-Åsberg Depression Rating Scale total score of ≥ 7 at screening (mild-to-severe MDE).
- •Failure of at least two trials of antidepressant therapy of adequate dose and duration during the current episode as established by the Antidepressant Treatment History Form and self-report.
- •Receiving treatments congruent with Canadian Network for Mood and Anxiety Treatments guidelines with no changes to treatments one month before screening (28 days).
排除标准
- •Current symptoms of mania, hypomania, mixed episodes, or psychosis.
- •Have received a diagnosis of alcohol or a substance use disorder within the past 3 months or as confirmed by the MINI. Other secondary psychiatric comorbidities (e.g., anxiety disorders, trauma-related disorders, etc.) will not be excluded.
- •Pregnant females.
- •Acute risk for a cardiovascular event (i.e., cardiovascular event in the past within the past 12 months).
- •Have any medical contraindications to exercise according to the Physical Activity Readiness Questionnaire.
- •Self-reported balance, gait, or locomotion difficulties that would preclude participation in a PA program.
- •Have any other condition that, in the opinion of the investigator(s), would adversely affect the subject's ability to complete the study or its measures.
- •Have exercise-induced asthma.
- •Taking medication that interferes with heart rate response to exercise, such as beta blockers.
- •Do not own a smartphone.
- •Do not have reliable access to the Internet.
- •Have previously received intravenous ketamine treatment in the last 2 months.
- •Non-English-speaking individuals are excluded because the ability to communicate study information, answer questions accurately and completely about the study, and obtain consent are necessary.
结局指标
主要结局
Feasibility
时间窗: 13 weeks
Recruitment rate, withdrawal rate, adherence rate, and data completion rate
Acceptability
时间窗: 13 weeks
Responses to an exit survey
次要结局
- General Anxiety Disorder-7(13 weeks)
- Patient Health Questionnaire-9(13 weeks)
- World Health Organization - Five Well-Being Index(13 weeks)
- Hamilton Depression Rating Scale-17(13 weeks)