Health BehaviorPhase 1NCT05150574
HRV and Coaching Preparation Phase Study
A Phase 1 study testing Core Health Program, Daily resting HRV and Momentary HRV feedback in people with Health Behavior and Work Related Stress, run by Brock University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Work Related Stress, Job Stress
- What is being tested?
- Core Health Program, Daily resting HRV and Momentary HRV feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2021to 31 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Health Behavior, Work Related Stress, Job Stress, Anxiety Depression
- Being tested
- Core Health Program, Daily resting HRV, Momentary HRV feedback, Behavioural initiation coaching, Practice with feedback coaching
- Keywords
- heart rate variability, health behaviour, anxiety, depression, job stress, well-being, health coaching
- Medical subject headings
- Health Behavior, Occupational Stress, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Health ProgramBehavioural
8-week structured stress management and health behaviour change program
Daily resting HRVBehavioural
Take regular HRV readings in the morning
Momentary HRV feedbackBehavioural
Take regular HRV readings throughout the day when stressed and perform mindfulness activity
Behavioural initiation coachingBehavioural
15-minute health coaching session in first week of program to help participant set goals and create an action plan
Practice with feedback coachingBehavioural
15-minute health coaching session in week 2 or 4 of program to help participant review goals and modify action plans if needed
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 | Experimental | Core Health platform only Receives: Behavioral: Core Health Program |
| Condition 2 | Experimental | Core Health platform plus Practice with feedback coaching Receives: Behavioral: Core Health Program; Behavioral: Practice with feedback coaching |
| Condition 3 | Experimental | Core Health platform plus behavioural initiation coaching Receives: Behavioral: Core Health Program; Behavioral: Behavioural initiation coaching |
| Condition 4 | Experimental | Core Health platform plus Practice with feedback coaching and behavioural initiation coaching Receives: Behavioral: Core Health Program; Behavioral: Behavioural initiation coaching; Behavioral: Practice with feedback coaching |
| Condition 5 | Experimental | Core Health platform plus Momentary HRV feedback Receives: Behavioral: Core Health Program; Behavioral: Momentary HRV feedback |
| Condition 6 | Experimental | Core Health platform plus Momentary HRV feedback and Practice with feedback coaching Receives: Behavioral: Core Health Program; Behavioral: Momentary HRV feedback; Behavioral: Practice with feedback coaching |
| Condition 7 | Experimental | Core Health platform plus Momentary HRV feedback and behavioural initiation coaching Receives: Behavioral: Core Health Program; Behavioral: Momentary HRV feedback; Behavioral: Behavioural initiation coaching |
| Condition 8 | Experimental | Core Health platform plus Momentary HRV feedback, behavioural initiation coaching, and Practice with feedback coaching Receives: Behavioral: Core Health Program; Behavioral: Momentary HRV feedback; Behavioral: Behavioural initiation coaching; Behavioral: Practice with feedback coaching |
| Condition 9 | Experimental | Core Health platform plus Daily resting HRV Receives: Behavioral: Core Health Program; Behavioral: Daily resting HRV |
| Condition 10 | Experimental | Core Health platform plus Daily resting HRV feedback and Practice with feedback coaching Receives: Behavioral: Core Health Program; Behavioral: Daily resting HRV; Behavioral: Practice with feedback coaching |
| Condition 11 | Experimental | Core Health platform plus Daily resting HRV feedback and Behavioural initiation coaching Receives: Behavioral: Core Health Program; Behavioral: Daily resting HRV; Behavioral: Behavioural initiation coaching |
| Condition 12 | Experimental | Core Health platform plus Daily resting HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching Receives: Behavioral: Core Health Program; Behavioral: Daily resting HRV; Behavioral: Behavioural initiation coaching; Behavioral: Practice with feedback coaching |
| Condition 13 | Experimental | Core Health platform plus Daily resting HRV feedback and Momentary HRV feedback Receives: Behavioral: Core Health Program; Behavioral: Daily resting HRV; Behavioral: Momentary HRV feedback |
| Condition 14 | Experimental | Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Practice with feedback coaching Receives: Behavioral: Core Health Program; Behavioral: Daily resting HRV; Behavioral: Momentary HRV feedback; Behavioral: Practice with feedback coaching |
| Condition 15 | Experimental | Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Behavioural initiation coaching Receives: Behavioral: Core Health Program; Behavioral: Daily resting HRV; Behavioral: Momentary HRV feedback; Behavioral: Behavioural initiation coaching |
| Condition 16 | Experimental | Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching Receives: Behavioral: Core Health Program; Behavioral: Daily resting HRV; Behavioral: Momentary HRV feedback; Behavioral: Behavioural initiation coaching; Behavioral: Practice with feedback coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: Assessment taken immediately after the intervention
Secondary outcomes (3)
Heart rate variability
7-day device-measured HRV
Measured: Assessment taken immediately before and after the intervention
Completion of survey measures
% of questionnaire measures answered and % missing data
Measured: Assessment taken immediately before and after the intervention
User engagement
number of times participants access the Core Health platform
Measured: continuously collected during 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Nov 2021
- Primary completion30 Jan 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brock University
- Sponsor type
- University, hospital or other
- Collaborators
- Mitacs
- Responsible party
- Principal investigator, Sean Locke, Brock University
- Investigators
- Sean Locke, PhD, Principal investigator, Brock University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150574
- Sponsor's protocol ID
- 20-367
- Status last verified
- Apr 2022
- First submitted
- 15 Nov 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing a Health Coaching and Heart Rate Variability Biofeedback Program to Improve Stress and Well-being
- ClinicalTrials.gov ID
- NCT05150574
- Acronym / sponsor ID
- 20-367
- Conditions
- Health Behavior, Work Related Stress, Job Stress, Anxiety Depression
- Keywords
- heart rate variability, health behaviour, anxiety, depression, job stress, well-being, health coaching
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Collaborators
- Mitacs
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Condition 1 | Experimental | Behavioral: Core Health ProgramCore Health platform only |
| Condition 2 | Experimental | Behavioral: Core Health Program, Behavioral: Practice with feedback coachingCore Health platform plus Practice with feedback coaching |
| Condition 3 | Experimental | Behavioral: Core Health Program, Behavioral: Behavioural initiation coachingCore Health platform plus behavioural initiation coaching |
| Condition 4 | Experimental | Behavioral: Core Health Program, Behavioral: Behavioural initiation coaching, Behavioral: Practice with feedback coachingCore Health platform plus Practice with feedback coaching and behavioural initiation coaching |
| Condition 5 | Experimental | Behavioral: Core Health Program, Behavioral: Momentary HRV feedbackCore Health platform plus Momentary HRV feedback |
| Condition 6 | Experimental | Behavioral: Core Health Program, Behavioral: Momentary HRV feedback, Behavioral: Practice with feedback coachingCore Health platform plus Momentary HRV feedback and Practice with feedback coaching |
| Condition 7 | Experimental | Behavioral: Core Health Program, Behavioral: Momentary HRV feedback, Behavioral: Behavioural initiation coachingCore Health platform plus Momentary HRV feedback and behavioural initiation coaching |
| Condition 8 | Experimental | Behavioral: Core Health Program, Behavioral: Momentary HRV feedback, Behavioral: Behavioural initiation coaching, Behavioral: Practice with feedback coachingCore Health platform plus Momentary HRV feedback, behavioural initiation coaching, and Practice with feedback coaching |
| Condition 9 | Experimental | Behavioral: Core Health Program, Behavioral: Daily resting HRVCore Health platform plus Daily resting HRV |
| Condition 10 | Experimental | Behavioral: Core Health Program, Behavioral: Daily resting HRV, Behavioral: Practice with feedback coachingCore Health platform plus Daily resting HRV feedback and Practice with feedback coaching |
| Condition 11 | Experimental | Behavioral: Core Health Program, Behavioral: Daily resting HRV, Behavioral: Behavioural initiation coachingCore Health platform plus Daily resting HRV feedback and Behavioural initiation coaching |
| Condition 12 | Experimental | Behavioral: Core Health Program, Behavioral: Daily resting HRV, Behavioral: Behavioural initiation coaching, Behavioral: Practice with feedback coachingCore Health platform plus Daily resting HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching |
| Condition 13 | Experimental | Behavioral: Core Health Program, Behavioral: Daily resting HRV, Behavioral: Momentary HRV feedbackCore Health platform plus Daily resting HRV feedback and Momentary HRV feedback |
| Condition 14 | Experimental | Behavioral: Core Health Program, Behavioral: Daily resting HRV, Behavioral: Momentary HRV feedback, Behavioral: Practice with feedback coachingCore Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Practice with feedback coaching |
| Condition 15 | Experimental | Behavioral: Core Health Program, Behavioral: Daily resting HRV, Behavioral: Momentary HRV feedback, Behavioral: Behavioural initiation coachingCore Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Behavioural initiation coaching |
| Condition 16 | Experimental | Behavioral: Core Health Program, Behavioral: Daily resting HRV, Behavioral: Momentary HRV feedback, Behavioral: Behavioural initiation coaching, Behavioral: Practice with feedback coachingCore Health platform plus Daily resting HRV feedback, Momentary HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core Health Program8-week structured stress management and health behaviour change program | Behavioural | Condition 1, Condition 10, Condition 11, Condition 12, Condition 13, Condition 14, Condition 15, Condition 16, Condition 2, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7, Condition 8, Condition 9 |
| Daily resting HRVTake regular HRV readings in the morning | Behavioural | Condition 10, Condition 11, Condition 12, Condition 13, Condition 14, Condition 15, Condition 16, Condition 9 |
| Momentary HRV feedbackTake regular HRV readings throughout the day when stressed and perform mindfulness activity | Behavioural | Condition 13, Condition 14, Condition 15, Condition 16, Condition 5, Condition 6, Condition 7, Condition 8 |
| Behavioural initiation coaching15-minute health coaching session in first week of program to help participant set goals and create an action plan | Behavioural | Condition 11, Condition 12, Condition 15, Condition 16, Condition 3, Condition 4, Condition 7, Condition 8 |
| Practice with feedback coaching15-minute health coaching session in week 2 or 4 of program to help participant review goals and modify action plans if needed | Behavioural | Condition 10, Condition 12, Condition 14, Condition 16, Condition 2, Condition 4, Condition 6, Condition 8 |
Primary outcome
Feasibility and acceptability of intervention components
Time frame: 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
Time frame: 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
Time frame: Assessment taken immediately after the intervention
Semi-structured interview questions to evaluate experiences, likes, dislikes, potential changes, and perceived feasibility
3 secondary outcomes
Heart rate variability
Time frame: Assessment taken immediately before and after the intervention
Completion of survey measures
Time frame: Assessment taken immediately before and after the intervention
User engagement
Time frame: continuously collected during 8-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Locke, PhD principal investigator
Brock University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Core Health Program, Daily resting HRV and Momentary HRV feedback in people with Health Behavior and Work Related Stress, run by Brock University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability of intervention components (time frame: Assessment taken immediately after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022; AzTrials last refreshed its copy on 27 Oct 2026.