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Completed

NCT Number: NCT05150574

HRV and Coaching Preparation Phase Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Brock University

St. Catharines, Ontario, L2S 3A1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Core Health Program

Behavioral

8-week structured stress management and health behaviour change program

Daily resting HRV

Behavioral

Take regular HRV readings in the morning

Momentary HRV feedback

Behavioral

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

Behavioural initiation coaching

Behavioral

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

Practice with feedback coaching

Behavioral

15-minute health coaching session in week 2 or 4 of program to help participant review goals and modify action plans if needed

Primary outcomes

  1. 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)

  2. 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

  3. 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

Secondary outcomes

  1. Heart rate variability

    Time frame: Assessment taken immediately before and after the intervention

    7-day device-measured HRV

  2. Completion of survey measures

    Time frame: Assessment taken immediately before and after the intervention

    % of questionnaire measures answered and % missing data

  3. User engagement

    Time frame: continuously collected during 8-week intervention

    number of times participants access the Core Health platform

Sponsors and collaborators

Lead sponsor

Brock University

Other

Collaborators

  • Mitacs

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 9, 2021
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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