A Pilot Randomized Controlled Trial of a Mental Fitness Intervention for Anesthesiology Resident Wellbeing and Self-Compassion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Intervention Acceptability (Acceptability of Intervention Measure, AIM)
研究概览
简要总结
The goal of this clinical trial is to learn if app-based wellness programs can help improve wellbeing and self-compassion for medical residents. This is a pilot study, which is done on a small group of people to learn if a larger study would be useful. The main questions it aims to answer are:
- Are app-based wellness interventions feasible and acceptable in a high-stress population like medical residents?
- Can app-based wellness programs improve wellbeing and self-compassion in medical residents?
Researchers will compare the app-based wellness program to a time- and attention-matched control program.
Participants will:
- Complete online questionnaires at the start of the study and again after completion of the wellness program
- Be assigned by chance (like a coin toss) to one of two different app-based programs, and will participate in the assigned program for 6 weeks. Both programs will involve weekly lessons and brief, daily exercises. Engagement with these exercises will not be mandatory but highly encouraged.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current PGY4 anesthesiology resident at Massachusetts General Hospital or Brigham and Women's Hospital
- •Willingness to provide informed consent
- •Resident Loved One Inclusion Criteria
- •The choice of a resident loved one will be at the discretion of the resident.
- •This may include partners, family, friends or other loved ones.
- •Only one individual per resident will be eligible to participate.
- •Residents will be eligible to participate even if no loved one is identified.
排除标准
- •Inability to complete English-language questionnaires
- •Inability to access and use the intervention components (smartphone app/web platform)
- •Age <18 years
- •Concurrent participation in another interventional study designed to target mental fitness or wellbeing
研究组 & 干预措施
PQ App
PQ bundled mental fitness intervention
干预措施: App-based bundled mental fitness intervention (Other)
Control App
Time- and attention-matched control wellness app
干预措施: App-based wellness module collection (Other)
结局指标
主要结局
Intervention Acceptability (Acceptability of Intervention Measure, AIM)
时间窗: At the end of study up to 12 weeks after enrollment
Acceptability of the assigned program, measured with the 4-item Acceptability of Intervention Measure (AIM). Each item is rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). The mean score ranges from 1 to 5, with higher scores indicating greater acceptability. Administered to both arms.
Intervention Appropriateness (Intervention Appropriateness Measure, IAM)
时间窗: At the end of study up to 12 weeks after enrollment
Perceived appropriateness and fit of the assigned program, measured with the 4-item Intervention Appropriateness Measure (IAM). Each item is rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). The mean score ranges from 1 to 5, with higher scores indicating greater perceived appropriateness. Administered to both arms.
Intervention Feasibility (Feasibility of Intervention Measure, FIM)
时间窗: At the end of study up to 12 weeks after enrollment
Perceived feasibility of the assigned program, measured with the 4-item Feasibility of Intervention Measure (FIM). Each item is rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). The mean score ranges from 1 to 5, with higher scores indicating greater perceived feasibility. Administered to both arms.
次要结局
- Self-compassion(Change from enrollment to end of study up to 12 weeks after enrollment)
- Burnout(Change from enrollment to end of study up to 12 weeks after enrollment)
- Depressive symptoms(Change from enrollment to end of study up to 12 weeks after enrollment)
- Anxiety symptoms(Change from enrollment to end of study up to 12 weeks after enrollment)
研究者
Johanna Lee
Assistant Program Director, Anesthesiology Residency
Massachusetts General Hospital