HRV and Coaching Preparation Phase Study

Sponsor

Brock University (Other)

Overall Status

Completed

CT.gov ID

NCT05150574

Collaborator

Mitacs (Industry)

Enrollment

Location

Arms

4.9

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Health Behavior Work Related Stress Job Stress Anxiety Depression	Behavioral: Core Health Program Behavioral: Daily resting HRV Behavioral: Momentary HRV feedback Behavioral: Behavioural initiation coaching Behavioral: Practice with feedback coaching	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 1, 2021

Actual Primary Completion Date :

Jan 30, 2022

Actual Study Completion Date :

Mar 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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)
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
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

Secondary Outcome Measures

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
User engagement [continuously collected during 8-week intervention]
number of times participants access the Core Health platform