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HRV and Coaching Preparation Phase Study

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05150574
Enrollment
16
Registered
2021-12-09
Start date
2021-11-01
Completion date
2022-03-31
Last updated
2022-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

heart rate variability, health behaviour, anxiety, depression, job stress, well-being, health coaching

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.

Interventions

BEHAVIORALCore Health Program

8-week structured stress management and health behaviour change program

BEHAVIORALDaily resting HRV

Take regular HRV readings in the morning

BEHAVIORALMomentary HRV feedback

Take regular HRV readings throughout the day when stressed and perform mindfulness activity

BEHAVIORALBehavioural initiation coaching

15-minute health coaching session in first week of program to help participant set goals and create an action plan

BEHAVIORALPractice 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

Sponsors

Mitacs
CollaboratorINDUSTRY
Brock University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Feasibility and acceptability of intervention componentsAssessment taken immediately after the interventionAcceptability 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 componentsAssessment taken immediately after the interventionSemi-structured interview questions to evaluate experiences, likes, dislikes, potential changes, and perceived feasibility
Health coach perceptions of intervention deliveryAssessment taken immediately after the interventionSemi-structured interview questions to evaluate experiences, likes, dislikes, potential changes, and perceived feasibility

Secondary

MeasureTime frameDescription
Heart rate variabilityAssessment taken immediately before and after the intervention7-day device-measured HRV
Completion of survey measuresAssessment taken immediately before and after the intervention% of questionnaire measures answered and % missing data
User engagementcontinuously collected during 8-week interventionnumber of times participants access the Core Health platform

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026