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HRV and Coaching Preparation Phase Study

Primary Purpose

Health Behavior, Work Related Stress, Job Stress

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Core Health Program
Daily resting HRV
Momentary HRV feedback
Behavioural initiation coaching
Practice with feedback coaching
Sponsored by
Brock University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Health Behavior focused on measuring heart rate variability, health behaviour, anxiety, depression, job stress, well-being, health coaching

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

-

Sites / Locations

  • Brock University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Condition 1

Condition 2

Condition 3

Condition 4

Condition 5

Condition 6

Condition 7

Condition 8

Condition 9

Condition 10

Condition 11

Condition 12

Condition 13

Condition 14

Condition 15

Condition 16

Arm Description

Core Health platform only

Core Health platform plus Practice with feedback coaching

Core Health platform plus behavioural initiation coaching

Core Health platform plus Practice with feedback coaching and behavioural initiation coaching

Core Health platform plus Momentary HRV feedback

Core Health platform plus Momentary HRV feedback and Practice with feedback coaching

Core Health platform plus Momentary HRV feedback and behavioural initiation coaching

Core Health platform plus Momentary HRV feedback, behavioural initiation coaching, and Practice with feedback coaching

Core Health platform plus Daily resting HRV

Core Health platform plus Daily resting HRV feedback and Practice with feedback coaching

Core Health platform plus Daily resting HRV feedback and Behavioural initiation coaching

Core Health platform plus Daily resting HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching

Core Health platform plus Daily resting HRV feedback and Momentary HRV feedback

Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Practice with feedback coaching

Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Behavioural initiation coaching

Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching

Outcomes

Primary Outcome Measures

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)
Participant perceptions of intervention components
Semi-structured interview questions to evaluate experiences, likes, dislikes, potential changes, and perceived feasibility
Health coach perceptions of intervention delivery
Semi-structured interview questions to evaluate experiences, likes, dislikes, potential changes, and perceived feasibility

Secondary Outcome Measures

Heart rate variability
7-day device-measured HRV
Completion of survey measures
% of questionnaire measures answered and % missing data
User engagement
number of times participants access the Core Health platform

Full Information

First Posted
November 15, 2021
Last Updated
April 11, 2022
Sponsor
Brock University
Collaborators
Mitacs
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1. Study Identification

Unique Protocol Identification Number
NCT05150574
Brief Title
HRV and Coaching Preparation Phase Study
Official Title
Pilot Testing a Health Coaching and Heart Rate Variability Biofeedback Program to Improve Stress and Well-being
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brock University
Collaborators
Mitacs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Behavior, Work Related Stress, Job Stress, Anxiety Depression
Keywords
heart rate variability, health behaviour, anxiety, depression, job stress, well-being, health coaching

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Condition 1
Arm Type
Experimental
Arm Description
Core Health platform only
Arm Title
Condition 2
Arm Type
Experimental
Arm Description
Core Health platform plus Practice with feedback coaching
Arm Title
Condition 3
Arm Type
Experimental
Arm Description
Core Health platform plus behavioural initiation coaching
Arm Title
Condition 4
Arm Type
Experimental
Arm Description
Core Health platform plus Practice with feedback coaching and behavioural initiation coaching
Arm Title
Condition 5
Arm Type
Experimental
Arm Description
Core Health platform plus Momentary HRV feedback
Arm Title
Condition 6
Arm Type
Experimental
Arm Description
Core Health platform plus Momentary HRV feedback and Practice with feedback coaching
Arm Title
Condition 7
Arm Type
Experimental
Arm Description
Core Health platform plus Momentary HRV feedback and behavioural initiation coaching
Arm Title
Condition 8
Arm Type
Experimental
Arm Description
Core Health platform plus Momentary HRV feedback, behavioural initiation coaching, and Practice with feedback coaching
Arm Title
Condition 9
Arm Type
Experimental
Arm Description
Core Health platform plus Daily resting HRV
Arm Title
Condition 10
Arm Type
Experimental
Arm Description
Core Health platform plus Daily resting HRV feedback and Practice with feedback coaching
Arm Title
Condition 11
Arm Type
Experimental
Arm Description
Core Health platform plus Daily resting HRV feedback and Behavioural initiation coaching
Arm Title
Condition 12
Arm Type
Experimental
Arm Description
Core Health platform plus Daily resting HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching
Arm Title
Condition 13
Arm Type
Experimental
Arm Description
Core Health platform plus Daily resting HRV feedback and Momentary HRV feedback
Arm Title
Condition 14
Arm Type
Experimental
Arm Description
Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Practice with feedback coaching
Arm Title
Condition 15
Arm Type
Experimental
Arm Description
Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, and Behavioural initiation coaching
Arm Title
Condition 16
Arm Type
Experimental
Arm Description
Core Health platform plus Daily resting HRV feedback, Momentary HRV feedback, Behavioural initiation coaching, and Practice with feedback coaching
Intervention Type
Behavioral
Intervention Name(s)
Core Health Program
Intervention Description
8-week structured stress management and health behaviour change program
Intervention Type
Behavioral
Intervention Name(s)
Daily resting HRV
Intervention Description
Take regular HRV readings in the morning
Intervention Type
Behavioral
Intervention Name(s)
Momentary HRV feedback
Intervention Description
Take regular HRV readings throughout the day when stressed and perform mindfulness activity
Intervention Type
Behavioral
Intervention Name(s)
Behavioural initiation coaching
Intervention Description
15-minute health coaching session in first week of program to help participant set goals and create an action plan
Intervention Type
Behavioral
Intervention Name(s)
Practice with feedback coaching
Intervention Description
15-minute health coaching session in week 2 or 4 of program to help participant review goals and modify action plans if needed
Primary Outcome Measure Information:
Title
Feasibility and acceptability of intervention components
Description
Acceptability and Feasibility of Intervention Measure (Scale range 1[completely disagree] to 5 [completely agree] with higher scores being better; Weiner et al., 2017)
Time Frame
Assessment taken immediately after the intervention
Title
Participant perceptions of intervention components
Description
Semi-structured interview questions to evaluate experiences, likes, dislikes, potential changes, and perceived feasibility
Time Frame
Assessment taken immediately after the intervention
Title
Health coach perceptions of intervention delivery
Description
Semi-structured interview questions to evaluate experiences, likes, dislikes, potential changes, and perceived feasibility
Time Frame
Assessment taken immediately after the intervention
Secondary Outcome Measure Information:
Title
Heart rate variability
Description
7-day device-measured HRV
Time Frame
Assessment taken immediately before and after the intervention
Title
Completion of survey measures
Description
% of questionnaire measures answered and % missing data
Time Frame
Assessment taken immediately before and after the intervention
Title
User engagement
Description
number of times participants access the Core Health platform
Time Frame
continuously collected during 8-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Locke, PhD
Organizational Affiliation
Brock University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brock University
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2S 3A1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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HRV and Coaching Preparation Phase Study

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