HRV and Coaching Preparation Phase Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Testing a Health Coaching and Heart Rate Variability Biofeedback Program to Improve Stress and Well-being

Conditions
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Health Behavior, Work Related Stress, Job Stress, Anxiety Depression

Intervention / Treatment
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* Behavioral: Core Health Program
* Behavioral: Daily resting HRV
* Behavioral: Momentary HRV feedback
* Behavioral: Behavioural initiation coaching
* Behavioral: Practice with feedback coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Condition 1<br>Core Health platform only | Behavioral: Core Health Program<br>* 8-week structured stress management and health behaviour change program<br>|
| Experimental: Condition 2<br>Core Health platform plus Practice with feedback coaching | Behavioral: Core Health Program<br>* 8-week structured stress management and health behaviour change program<br>Behavioral: Practice with feedback coaching<br>* 15-minute health coaching session in week 2 or 4 of program to help participant review goals and modify action plans if needed<br>|
| Experimental: Condition 3<br>Core Health platform plus behavioural initiation coaching | Behavioral: Core Health Program<br>* 8-week structured stress management and health behaviour change program<br>Behavioral: Behavioural initiation coaching<br>* 15-minute health coaching session in first week of program to help participant set goals and create an action plan<br>|
| Experimental: Condition 4<br>Core Health platform plus Practice with feedback coaching and behavioural initiation coaching | Behavioral: Core Health Program<br>* 8-week structured stress management and health behaviour change program<br>Behavioral: Behavioural initiation coaching<br>* 15-minute health coaching session in first week of program to help participant set goals and create an action plan<br>Behavioral: Practice with feedback coaching<br>* 15-minute health coaching session in week 2 or 4 of program to help participant review goals and modify action plans if needed<br>|
| Experimental: Condition 5<br>Core Health platform plus Momentary HRV feedback | Behavioral: Core Health Program<br>* 8-week structured stress management and health behaviour change program<br>Behavioral: Momentary HRV feedback<br>* Take regular HRV readings throughout the day when stressed and perform mindfulness activity<br>|
| Experimental: Condition 6<br>Core Health platform plus Momentary HRV feedback and Practice with feedback coaching | Behavioral: Core Health Program<br>* 8-week structured stress management and health behaviour change program<br>Behavioral: Momentary HRV feedback<br>* Take regular HRV readings throughout the day when stressed and perform mindfulness activity<br>Behavioral: Practice with feedback coaching<br>* 15-minute health coaching session in week 2 or 4 of program to help participant review goals and modify action plans if needed<br>|
| Experimental: Condition 7<br>Core Health platform plus Momentary HRV feedback and behavioural initiation coaching | Behavioral: Core Health Program<br>* 8-week structured stress management and health behaviour change program<br>Behavioral: Momentary HRV feedback<br>* Take regular HRV readings throughout the day when stressed and perform mindfulness activity<br>Behavioral: Behavioural initiation coaching<br>* 15-minute health coaching session in first week of program to help participant set goals and create an action plan<br>|
| Experimental: Condition 8<br>Core Health platform plus Momentary HRV feedback, behavioural initiation coaching, and Practice with feedback coaching | Behavioral: Core Health Program<br>* 8-week structured stress management and health behaviour change program<br>Behavioral: Momentary HRV feedback<br>* Take regular HRV readings throughout the day when stressed and perform mindfulness activity<br>Behavioral: Behavioural initiation coaching<br>* 15-minute health coaching session in first week of program to help participant set goals and create an action plan<br>Behavioral: Practice with feedback coaching<br>* 15-minute health coaching session in week 2 or 4 of program to help participant review goals and modify action plans if needed<br>|
| Experimental: Condition 9<br>Core Health platform plus Daily resting HRV | Behavioral: Core Health Program<br>* 8-week structured stress management and health behaviour change program<br>Behavioral: Daily resting HRV<br>* Take regular HRV readings in the morning<br>|
| Experimental: Condition 10<br>Core Health platform plus Daily resting HRV feedback and Practice with feedback coaching | Behavioral: Core Health Program<br>* 8-week structured stress management and health behaviour change program<br>Behavioral: Daily resting HRV<br>* Take regular HRV readings in the morning<br>Behavioral: Practice with feedback coaching<br>* 15-minute health coaching session in week 2 or 4 of program to help participant review goals and modify action plans if needed<br>|
| Experimental: Condition 11<br>Core Health platform plus Daily resting HRV feedback and Behavioural initiation coaching | Behavioral: Core Health Program<br>* 8-week structured stress management and health behaviour change program<br>Behavioral: Daily resting HRV<br>* Take regular HRV readings in the morning<br>Behavioral: Behavioural initiation coaching<br>* 15-minute health coaching session in first week of program to help participant set goals and create an action plan<br>|
| Experimental: Condition 12<br>Core Health platform plus Daily resting HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching | Behavioral: Core Health Program<br>* 8-week structured stress management and health behaviour change program<br>Behavioral: Daily resting HRV<br>* Take regular HRV readings in the morning<br>Behavioral: Behavioural initiation coaching<br>* 15-minute health coaching session in first week of program to help participant set goals and create an action plan<br>Behavioral: Practice with feedback coaching<br>* 15-minute health coaching session in week 2 or 4 of program to help participant review goals and modify action plans if needed<br>|
| Experimental: Condition 13<br>Core Health platform plus Daily resting HRV feedback and Momentary HRV feedback | Behavioral: Core Health Program<br>* 8-week structured stress management and health behaviour change program<br>Behavioral: Daily resting HRV<br>* Take regular HRV readings in the morning<br>Behavioral: Momentary HRV feedback<br>* Take regular HRV readings throughout the day when stressed and perform mindfulness activity<br>|
| Experimental: Condition 14<br>Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Practice with feedback coaching | Behavioral: Core Health Program<br>* 8-week structured stress management and health behaviour change program<br>Behavioral: Daily resting HRV<br>* Take regular HRV readings in the morning<br>Behavioral: Momentary HRV feedback<br>* Take regular HRV readings throughout the day when stressed and perform mindfulness activity<br>Behavioral: Practice with feedback coaching<br>* 15-minute health coaching session in week 2 or 4 of program to help participant review goals and modify action plans if needed<br>|
| Experimental: Condition 15<br>Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Behavioural initiation coaching | Behavioral: Core Health Program<br>* 8-week structured stress management and health behaviour change program<br>Behavioral: Daily resting HRV<br>* Take regular HRV readings in the morning<br>Behavioral: Momentary HRV feedback<br>* Take regular HRV readings throughout the day when stressed and perform mindfulness activity<br>Behavioral: Behavioural initiation coaching<br>* 15-minute health coaching session in first week of program to help participant set goals and create an action plan<br>|
| Experimental: Condition 16<br>Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching | Behavioral: Core Health Program<br>* 8-week structured stress management and health behaviour change program<br>Behavioral: Daily resting HRV<br>* Take regular HRV readings in the morning<br>Behavioral: Momentary HRV feedback<br>* Take regular HRV readings throughout the day when stressed and perform mindfulness activity<br>Behavioral: Behavioural initiation coaching<br>* 15-minute health coaching session in first week of program to help participant set goals and create an action plan<br>Behavioral: Practice with feedback coaching<br>* 15-minute health coaching session in week 2 or 4 of program to help participant review goals and modify action plans if needed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and acceptability of intervention components | Acceptability and Feasibility of Intervention Measure (Scale range 1[completely disagree] to 5 [completely agree] with higher scores being better; Weiner et al., 2017) | Assessment taken immediately after the intervention | 
| Participant perceptions of intervention components | Semi-structured interview questions to evaluate experiences, likes, dislikes, potential changes, and perceived feasibility | Assessment taken immediately after the intervention | 
| Health coach perceptions of intervention delivery | Semi-structured interview questions to evaluate experiences, likes, dislikes, potential changes, and perceived feasibility | Assessment taken immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability | 7-day device-measured HRV | Assessment taken immediately before and after the intervention | 
| Completion of survey measures | % of questionnaire measures answered and % missing data | Assessment taken immediately before and after the intervention | 
| User engagement | number of times participants access the Core Health platform | continuously collected during 8-week intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart rate variability, health behaviour, anxiety, depression, job stress, well-being, health coaching