Pilot Testing a Health Coaching and Heart Rate Variability Biofeedback Program to Improve Stress and Well-being
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Feasibility and acceptability of intervention components
研究概览
简要总结
This pilot study will evaluate possible intervention components to be included in a future stress management and health behaviour change trial and to pilot test their feasibility and acceptability in a small sample.
详细描述
Work is one of the greatest contributors to chronic stress. Chronic stress is a critical risk factor leading to several negative work- and health-related outcomes. Developing scalable stress-management interventions will improve workers' health and wellness. The purpose of this project is to develop an optimized a stress reduction behavioural coaching and biofeedback intervention to supplement an existing mHealth platform (consisting of behavioural web-based modules). By testing coaching and biofeedback, this project can determine what level of interaction with a trained coach is necessary to optimally reduce workers' stress, and improve their health and well-being. To achieve this purpose, the multiphase optimization strategy (MOST) will be employed to develop, optimize, and evaluate the efficacy of this intervention. The three-phases include: preparation (selecting which intervention components are feasible to examine), optimization (determining the optimized package of components), and evaluation (evaluating the efficacy of the optimized package through a randomized control trial). This trial will cover the first phase of the MOST protocol. This pilot study will evaluate possible intervention components to be included in a future stress management and health behaviour change trial and to pilot test their feasibility and acceptability in a small sample.
Preparation phase objectives:
1.1 Determine which candidate components will be tested in a later optimization phase and at what dose they will be tested 1.2 Examine the feasibility of delivering the different components 1.3 Examine the acceptability of delivering the different components 1.4 Evaluate whether the outcomes can be feasibly measured
Design overview: A 2^4 (2x2x2x2) factorial experiment will run in the next phase of this project to test all combinations of four candidate components "turned on and off" with 16 different conditions. In the present study, we will ask 16 participants to each participate in and evaluate one of the sixteen conditions. The four candidate components being tested are: Daily resting HRV biofeedback, Momentary HRV biofeedback, Behavioural initiation coaching, and Practice with feedback coaching. Additionally, all participants will be asked to use complete the 8-week health behaviour change and stress management program on the Core health mHealth platform. Participants will be randomized to completing one of the sixteen conditions while completing the eight-week CoreHealth program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
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
- •18 years and older
- •Able to read and comprehend English
- •Have smart phone (Android or iPhone 8 or higher)
- •Self-report BMI under 40
- •report at least Moderate daily stress
排除标准
- 未提供
研究组 & 干预措施
Condition 3
Core Health platform plus behavioural initiation coaching
干预措施: Core Health Program (Behavioral)
Condition 3
Core Health platform plus behavioural initiation coaching
干预措施: Behavioural initiation coaching (Behavioral)
Condition 7
Core Health platform plus Momentary HRV feedback and behavioural initiation coaching
干预措施: Core Health Program (Behavioral)
Condition 7
Core Health platform plus Momentary HRV feedback and behavioural initiation coaching
干预措施: Momentary HRV feedback (Behavioral)
Condition 12
Core Health platform plus Daily resting HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching
干预措施: Core Health Program (Behavioral)
Condition 12
Core Health platform plus Daily resting HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching
干预措施: Daily resting HRV (Behavioral)
Condition 12
Core Health platform plus Daily resting HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching
干预措施: Practice with feedback coaching (Behavioral)
Condition 13
Core Health platform plus Daily resting HRV feedback and Momentary HRV feedback
干预措施: Daily resting HRV (Behavioral)
Condition 14
Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Practice with feedback coaching
干预措施: Core Health Program (Behavioral)
Condition 1
Core Health platform only
干预措施: Core Health Program (Behavioral)
Condition 2
Core Health platform plus Practice with feedback coaching
干预措施: Core Health Program (Behavioral)
Condition 2
Core Health platform plus Practice with feedback coaching
干预措施: Practice with feedback coaching (Behavioral)
Condition 4
Core Health platform plus Practice with feedback coaching and behavioural initiation coaching
干预措施: Core Health Program (Behavioral)
Condition 4
Core Health platform plus Practice with feedback coaching and behavioural initiation coaching
干预措施: Behavioural initiation coaching (Behavioral)
Condition 6
Core Health platform plus Momentary HRV feedback and Practice with feedback coaching
干预措施: Practice with feedback coaching (Behavioral)
Condition 7
Core Health platform plus Momentary HRV feedback and behavioural initiation coaching
干预措施: Behavioural initiation coaching (Behavioral)
Condition 10
Core Health platform plus Daily resting HRV feedback and Practice with feedback coaching
干预措施: Daily resting HRV (Behavioral)
Condition 11
Core Health platform plus Daily resting HRV feedback and Behavioural initiation coaching
干预措施: Core Health Program (Behavioral)
Condition 11
Core Health platform plus Daily resting HRV feedback and Behavioural initiation coaching
干预措施: Daily resting HRV (Behavioral)
Condition 11
Core Health platform plus Daily resting HRV feedback and Behavioural initiation coaching
干预措施: Behavioural initiation coaching (Behavioral)
Condition 12
Core Health platform plus Daily resting HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching
干预措施: Behavioural initiation coaching (Behavioral)
Condition 13
Core Health platform plus Daily resting HRV feedback and Momentary HRV feedback
干预措施: Core Health Program (Behavioral)
Condition 13
Core Health platform plus Daily resting HRV feedback and Momentary HRV feedback
干预措施: Momentary HRV feedback (Behavioral)
Condition 14
Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Practice with feedback coaching
干预措施: Momentary HRV feedback (Behavioral)
Condition 15
Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Behavioural initiation coaching
干预措施: Momentary HRV feedback (Behavioral)
Condition 16
Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching
干预措施: Momentary HRV feedback (Behavioral)
Condition 16
Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching
干预措施: Behavioural initiation coaching (Behavioral)
Condition 4
Core Health platform plus Practice with feedback coaching and behavioural initiation coaching
干预措施: Practice with feedback coaching (Behavioral)
Condition 5
Core Health platform plus Momentary HRV feedback
干预措施: Core Health Program (Behavioral)
Condition 6
Core Health platform plus Momentary HRV feedback and Practice with feedback coaching
干预措施: Core Health Program (Behavioral)
Condition 6
Core Health platform plus Momentary HRV feedback and Practice with feedback coaching
干预措施: Momentary HRV feedback (Behavioral)
Condition 8
Core Health platform plus Momentary HRV feedback, behavioural initiation coaching, and Practice with feedback coaching
干预措施: Core Health Program (Behavioral)
Condition 8
Core Health platform plus Momentary HRV feedback, behavioural initiation coaching, and Practice with feedback coaching
干预措施: Momentary HRV feedback (Behavioral)
Condition 8
Core Health platform plus Momentary HRV feedback, behavioural initiation coaching, and Practice with feedback coaching
干预措施: Behavioural initiation coaching (Behavioral)
Condition 8
Core Health platform plus Momentary HRV feedback, behavioural initiation coaching, and Practice with feedback coaching
干预措施: Practice with feedback coaching (Behavioral)
Condition 9
Core Health platform plus Daily resting HRV
干预措施: Core Health Program (Behavioral)
Condition 9
Core Health platform plus Daily resting HRV
干预措施: Daily resting HRV (Behavioral)
Condition 10
Core Health platform plus Daily resting HRV feedback and Practice with feedback coaching
干预措施: Core Health Program (Behavioral)
Condition 10
Core Health platform plus Daily resting HRV feedback and Practice with feedback coaching
干预措施: Practice with feedback coaching (Behavioral)
Condition 14
Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Practice with feedback coaching
干预措施: Practice with feedback coaching (Behavioral)
Condition 15
Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Behavioural initiation coaching
干预措施: Core Health Program (Behavioral)
Condition 15
Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Behavioural initiation coaching
干预措施: Daily resting HRV (Behavioral)
Condition 15
Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Behavioural initiation coaching
干预措施: Behavioural initiation coaching (Behavioral)
Condition 14
Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Practice with feedback coaching
干预措施: Daily resting HRV (Behavioral)
Condition 16
Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching
干预措施: Core Health Program (Behavioral)
Condition 16
Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching
干预措施: Daily resting HRV (Behavioral)
Condition 16
Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching
干预措施: Practice with feedback coaching (Behavioral)
Condition 5
Core Health platform plus Momentary HRV feedback
干预措施: Momentary HRV feedback (Behavioral)
结局指标
主要结局
Feasibility and acceptability of intervention components
时间窗: Assessment taken immediately after the intervention
Acceptability and Feasibility of Intervention Measure (Scale range 1\[completely disagree\] to 5 \[completely agree\] with higher scores being better; Weiner et al., 2017)
Health coach perceptions of intervention delivery
时间窗: Assessment taken immediately after the intervention
Semi-structured interview questions to evaluate experiences, likes, dislikes, potential changes, and perceived feasibility
Participant perceptions of intervention components
时间窗: Assessment taken immediately after the intervention
Semi-structured interview questions to evaluate experiences, likes, dislikes, potential changes, and perceived feasibility
次要结局
- User engagement(continuously collected during 8-week intervention)
- Heart rate variability(Assessment taken immediately before and after the intervention)
- Completion of survey measures(Assessment taken immediately before and after the intervention)
研究者
Sean Locke
Principal Investigator
Brock University