HRV and Coaching Preparation Phase Study

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety Depression; Health Behavior; Work Related Stress; Job Stress
• Intervention / Treatment: Behavioral: Core Health Program; Behavioral: Practice with feedback coaching; Behavioral: Behavioural initiation coaching; Behavioral: Momentary HRV feedback; Behavioral: Daily resting HRV

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • St. Catharines, Ontario, Canada, L2S 3A1
      • Brock University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

16

Arms and Interventions

Participant Group / 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: 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; 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 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: 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; Behavioral: Momentary HRV feedback; Take regular HRV readings throughout the day when stressed and perform mindfulness activity
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: Behavioural initiation coaching; 15-minute health coaching session in first week of program to help participant set goals and create an action plan; Behavioral: Momentary HRV feedback; Take regular HRV readings throughout the day when stressed and perform mindfulness activity
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: 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; 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: Momentary HRV feedback; Take regular HRV readings throughout the day when stressed and perform mindfulness activity
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: 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; Behavioral: Daily resting HRV; Take regular HRV readings in the morning
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: Behavioural initiation coaching; 15-minute health coaching session in first week of program to help participant set goals and create an action plan; Behavioral: Daily resting HRV; Take regular HRV readings in the morning
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: 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; 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: Daily resting HRV; Take regular HRV readings in the morning
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: Momentary HRV feedback; Take regular HRV readings throughout the day when stressed and perform mindfulness activity; Behavioral: Daily resting HRV; Take regular HRV readings in the morning
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: 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; Behavioral: Momentary HRV feedback; Take regular HRV readings throughout the day when stressed and perform mindfulness activity; Behavioral: Daily resting HRV; Take regular HRV readings in the morning
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: Behavioural initiation coaching; 15-minute health coaching session in first week of program to help participant set goals and create an action plan; Behavioral: Momentary HRV feedback; Take regular HRV readings throughout the day when stressed and perform mindfulness activity; Behavioral: Daily resting HRV; Take regular HRV readings in the morning
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: 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; 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: Momentary HRV feedback; Take regular HRV readings throughout the day when stressed and perform mindfulness activity; Behavioral: Daily resting HRV; Take regular HRV readings in the morning

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brock University
• Collaborators: Mitacs
• Investigators: Principal Investigator: Sean Locke, PhD, Brock University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): January 30, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: depression; anxiety; well-being; job stress; heart rate variability; health behaviour; health coaching
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Occupational Diseases; Depression; Occupational Stress
• Other Study ID Numbers: 20-367

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No