HRV and Coaching Preparation Phase Study
- Conditions
- Health BehaviorWork Related StressJob StressAnxiety Depression
- Interventions
- Behavioral: Core Health ProgramBehavioral: Daily resting HRVBehavioral: Momentary HRV feedbackBehavioral: Practice with feedback coachingBehavioral: Behavioural initiation coaching
- Registration Number
- NCT05150574
- Lead Sponsor
- Brock University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Condition 4 Core Health Program Core Health platform plus Practice with feedback coaching and behavioural initiation coaching Condition 8 Core Health Program Core Health platform plus Momentary HRV feedback, behavioural initiation coaching, and Practice with feedback coaching Condition 7 Core Health Program Core Health platform plus Momentary HRV feedback and behavioural initiation coaching Condition 10 Daily resting HRV Core Health platform plus Daily resting HRV feedback and Practice with feedback coaching Condition 11 Core Health Program Core Health platform plus Daily resting HRV feedback and Behavioural initiation coaching Condition 5 Momentary HRV feedback Core Health platform plus Momentary HRV feedback Condition 8 Momentary HRV feedback Core Health platform plus Momentary HRV feedback, behavioural initiation coaching, and Practice with feedback coaching Condition 2 Practice with feedback coaching Core Health platform plus Practice with feedback coaching Condition 4 Practice with feedback coaching Core Health platform plus Practice with feedback coaching and behavioural initiation coaching Condition 6 Momentary HRV feedback Core Health platform plus Momentary HRV feedback and Practice with feedback coaching Condition 7 Momentary HRV feedback Core Health platform plus Momentary HRV feedback and behavioural initiation coaching Condition 1 Core Health Program Core Health platform only Condition 2 Core Health Program Core Health platform plus Practice with feedback coaching Condition 3 Core Health Program Core Health platform plus behavioural initiation coaching Condition 3 Behavioural initiation coaching Core Health platform plus behavioural initiation coaching Condition 4 Behavioural initiation coaching Core Health platform plus Practice with feedback coaching and behavioural initiation coaching Condition 5 Core Health Program Core Health platform plus Momentary HRV feedback Condition 6 Core Health Program Core Health platform plus Momentary HRV feedback and Practice with feedback coaching Condition 6 Practice with feedback coaching Core Health platform plus Momentary HRV feedback and Practice with feedback coaching Condition 10 Practice with feedback coaching Core Health platform plus Daily resting HRV feedback and Practice with feedback coaching Condition 7 Behavioural initiation coaching Core Health platform plus Momentary HRV feedback and behavioural initiation coaching Condition 9 Core Health Program Core Health platform plus Daily resting HRV Condition 12 Core Health Program Core Health platform plus Daily resting HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching Condition 13 Core Health Program Core Health platform plus Daily resting HRV feedback and Momentary HRV feedback Condition 15 Daily resting HRV Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Behavioural initiation coaching Condition 8 Behavioural initiation coaching Core Health platform plus Momentary HRV feedback, behavioural initiation coaching, and Practice with feedback coaching Condition 9 Daily resting HRV Core Health platform plus Daily resting HRV Condition 10 Core Health Program Core Health platform plus Daily resting HRV feedback and Practice with feedback coaching Condition 15 Behavioural initiation coaching Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Behavioural initiation coaching Condition 8 Practice with feedback coaching Core Health platform plus Momentary HRV feedback, behavioural initiation coaching, and Practice with feedback coaching Condition 11 Behavioural initiation coaching Core Health platform plus Daily resting HRV feedback and Behavioural initiation coaching Condition 12 Practice with feedback coaching Core Health platform plus Daily resting HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching Condition 15 Momentary HRV feedback Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Behavioural initiation coaching Condition 16 Core Health Program Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching Condition 16 Daily resting HRV Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching Condition 16 Momentary HRV feedback Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching Condition 16 Behavioural initiation coaching Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching Condition 11 Daily resting HRV Core Health platform plus Daily resting HRV feedback and Behavioural initiation coaching Condition 12 Behavioural initiation coaching Core Health platform plus Daily resting HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching Condition 13 Momentary HRV feedback Core Health platform plus Daily resting HRV feedback and Momentary HRV feedback Condition 14 Daily resting HRV Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Practice with feedback coaching Condition 14 Momentary HRV feedback Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Practice with feedback coaching Condition 14 Practice with feedback coaching Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Practice with feedback coaching Condition 16 Practice with feedback coaching Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching Condition 12 Daily resting HRV Core Health platform plus Daily resting HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching Condition 13 Daily resting HRV Core Health platform plus Daily resting HRV feedback and Momentary HRV feedback Condition 14 Core Health Program Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Practice with feedback coaching Condition 15 Core Health Program Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Behavioural initiation coaching
- Primary Outcome Measures
Name Time Method Feasibility and acceptability of intervention components 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 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 Assessment taken immediately after the intervention Semi-structured interview questions to evaluate experiences, likes, dislikes, potential changes, and perceived feasibility
- Secondary Outcome Measures
Name Time Method User engagement continuously collected during 8-week intervention number of times participants access the Core Health platform
Heart rate variability Assessment taken immediately before and after the intervention 7-day device-measured HRV
Completion of survey measures Assessment taken immediately before and after the intervention % of questionnaire measures answered and % missing data
Trial Locations
- Locations (1)
Brock University
🇨🇦St. Catharines, Ontario, Canada