HRV and Coaching Preparation Phase Study

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05150574
• Other study ID #: 20-367
• Status: Completed
• Phase: Phase 1
• Start date: November 1, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2022
• Source: Brock University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 31, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Anxiety Depression
• Depression
• Health Behavior
• Job Stress
• Occupational Stress
• Work Related Stress

Intervention

Behavioral:
• Core Health Program
8-week structured stress management and health behaviour change program
• Daily resting HRV
Take regular HRV readings in the morning
• Momentary HRV feedback
Take regular HRV readings throughout the day when stressed and perform mindfulness activity
• Behavioural initiation coaching
15-minute health coaching session in first week of program to help participant set goals and create an action plan
• 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

Locations

Country	Name	City	State
Canada	Brock University	St. Catharines	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Brock University	Mitacs

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Heart rate variability	7-day device-measured HRV	Assessment taken immediately before and after the intervention
Secondary	Completion of survey measures	% of questionnaire measures answered and % missing data	Assessment taken immediately before and after the intervention
Secondary	User engagement	number of times participants access the Core Health platform	continuously collected during 8-week intervention