Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000401651
Ethics application status
Approved
Date submitted
31/03/2023
Date registered
19/04/2023
Date last updated
21/07/2024
Date data sharing statement initially provided
19/04/2023
Date results provided
21/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Stress Management with a Virtual Health Coach
Scientific title
Stress Management with a Virtual Health Coach: A Randomised Controlled Trial Investigating the Effects of a Negotiated Treatment Plan on Adherence
Secondary ID [1] 309268 0
nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment Adherence 329498 0
Condition category
Condition code
Mental Health 326434 326434 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will take place entirely online. The questionnaires will be administered using Qualtrics software. The virtual health coach is programmed and designed using software provided by Soul Machines, and participants will access the consultation on a website supported by Soul Machines.

Participants will be informed that the present study will explore the usefulness of a virtual health coach for helping people with stress management. Yet, the true primary objective is to investigate whether a stress management plan negotiated with a virtual health coach will positively influence their adherence to recommendations. In addition, participants will not be informed of the different conditions or their allocated group. This method ensures that participants do not adhere to their stress management plan differently because they know this factor is being assessed.

A negotiated plan refers to a treatment regimen that is collaboratively developed by both the patient and their physician. Participants in the intervention condition will respond to a consultation script that follows the framework outlined by Gask & Underwood (2002). The virtual health coach first ascertains the participant’s expectations about their treatment by asking how much they know about stress management. The virtual health coach then suggests two stress management techniques for the participant: physical and relaxation exercises. For both approaches, the virtual health coach elicits the participant’s preferences by asking about the type of outcome they would hope to gain from these techniques. The virtual health coach will make recommendations seemingly based on these preferences. Finally, the virtual health coach will check with the participant to ensure they are clear about their treatment plan and advise on contingency management (e.g. “If you miss a day, just do it the next day”). These consultations will be individually delivered, once only. These consultations will be administered entirely online. They should take no longer than 10 minutes.

Regardless of participants’ preferences, the virtual health coach will always recommend the same stress management plan: 15 minutes of mindful walking five times a week and 10 minutes of progressive muscle relaxation exercises once a day. Participants are recommended to engage in this stress management plan over 4 weeks. In fact, all participants will receive the same stress management plan, but it will be presented differently in each condition. The reason all participants are given the same recommendations is that any variation would create confounding factors (e.g. participants may be more willing to adhere to one exercise than another) that would affect the outcomes of the study. The virtual health coach will give the intervention group a plan that displays a range of exercises with their recommendations circled, to reinforce the perception that these recommendations are specific to the participant. In comparison, the control group will receive a copy of their treatment plan that only displays their recommended exercises. This approach is based on a study conducted by Bashyam et al. in which similar placebo-tailored treatment plans improved patient satisfaction, perception of personalisation and willingness to adhere (2020).

This study's stress management plan has been specifically developed using the following evidence. As part of their stress management plan, participants will be recommended to engage in mindful walking for 15 minutes, 5 times a week. This exercise involves walking in nature while deeply experiencing one’s surroundings and being physically present rather than focusing on a destination (Kabat-Zinn, 2017). In their systematic review, Kondo et al. assert that studies using self-report measures and stress biomarkers provide convincing evidence that time spent in outdoor environments reduces the experience of stress (2018). In particular, most studies that asked participants to walk through a forest or a park for 15-30 minutes demonstrated notable reductions in stress measures. Physical exercise is also a known moderator of stress (Flueckiger et al., 2016). The present study combines this practice with Kabat-Zinn’s walking meditation resources (2017). Kabat-Zinn leads an extensive body of literature regarding mindfulness and developed the evidence-based mindfulness-based stress reduction (MBSR) program. Participants will walk outside while listening to an audio track that guides them through mindfulness techniques. Participants will also be recommended to engage in progressive muscle relaxation (PMR) exercises for 10 minutes, once a day. PMR involves tensing and relaxing the muscle groups, one at a time. This relaxation technique helps people manage the physical effects of stress and in doing so, relax their minds. There is substantial evidence supporting the efficacy of progressive muscle relaxation as a technique for reducing stress, with meta-analyses showing greater effect sizes for PMR than other techniques (Manzoni et al., 2008). Participants will also receive advice regarding healthy eating and sleeping to provide participants with a fully evidence-based stress management plan.

The virtual health coach will provide resources, including short audio tracks and written guides, to support participants in the recommended mindful walking and progressive muscle relaxation exercises. These resources are provided on a website where all participants must create an account to access them. Whether participants create an account and the number of times they click on the resources will provide the researchers with an objective measure of their adherence to the stress management plan.

Participants will be debriefed at 4-weeks post-consultation after completing follow-up questionnaires.
Intervention code [1] 325745 0
Behaviour
Comparator / control treatment
This study will take place entirely online. The questionnaires will be administered using Qualtrics software. The virtual health coach is programmed and designed using software provided by Soul Machines, and participants will access the consultation on a website supported by Soul Machines.

Participants will be informed that the present study will explore the usefulness of a virtual health coach for helping people with stress management. Yet, the true primary objective is to investigate whether a stress management plan negotiated with a virtual health coach will positively influence their adherence to recommendations. In addition, participants will not be informed of the different conditions or their allocated group. This method ensures that participants do not adhere to their stress management plan differently because they know this factor is being assessed.

The controlled consultation involves the virtual health coach simply prescribing the stress management plan to the participant. In this condition, the virtual health coach will not ask for input from the participant regarding their expectations or preferences. Further, the health coach will not check whether participants understand their treatment plan or offer any contingency management advice. Aside from these key differences, the virtual health coach will follow a similar script and recommend the same stress management plan as the intervention condition. Both conditions are designed to take an equal amount of time and contain the same amount of participant interaction with the virtual health coach. These consultations will be individually delivered, once only. These consultations will be administered entirely online. They should take no longer than 10 minutes.

All participants will receive the same stress management plan: 15 minutes of mindful walking five times a week and 10 minutes of progressive muscle relaxation exercises once a day. This will be presented differently in each condition. The reason all participants are given the same recommendations is that any variation would create confounding factors (e.g. participants may be more willing to adhere to one exercise than another) that would affect the outcomes of the study. While the intervention group received the placebo-tailored version, the control group will just receive a copy of their treatment plan that only displays their recommended exercises. This approach is based on a study conducted by Bashyam et al. in which similar placebo-tailored treatment plans improved patient satisfaction, perception of personalisation and willingness to adhere (2020).

As part of their stress management plan, participants will be recommended to engage in mindful walking for 15 minutes, 5 times a week. This exercise involves walking in nature while deeply experiencing one’s surroundings and being physically present rather than focusing on a destination (Kabat-Zinn, 2017). In their systematic review, Kondo et al. assert that studies using self-report measures and stress biomarkers provide convincing evidence that time spent in outdoor environments reduces the experience of stress (2018). In particular, most studies that asked participants to walk through a forest or a park for 15-30 minutes demonstrated notable reductions in stress measures. Physical exercise is also a known moderator of stress (Flueckiger et al., 2016). The present study combines this practice with Kabat-Zinn’s walking meditation resources (2017). Kabat-Zinn leads an extensive body of literature regarding mindfulness and developed the evidence-based mindfulness-based stress reduction (MBSR) program. Participants will walk outside while listening to an audio track that guides them through mindfulness techniques. Participants will also be recommended to engage in progressive muscle relaxation (PMR) exercises for 10 minutes, once a day. PMR involves tensing and relaxing the muscle groups, one at a time. This relaxation technique helps people manage the physical effects of stress and in doing so, relax their minds. There is substantial evidence supporting the efficacy of progressive muscle relaxation as a technique for reducing stress, with meta-analyses showing greater effect sizes for PMR than other techniques (Manzoni et al., 2008). Participants will also receive advice regarding healthy eating and sleeping to provide participants with a fully evidence-based stress management plan.

The virtual health coach will provide resources, including short audio tracks and written guides, to support participants in the recommended mindful walking and progressive muscle relaxation exercises. These resources are provided on a website where all participants must create an account to access them. Whether participants create an account and the number of times they click on the resources will provide the researchers with an objective measure of their adherence to the stress management plan.

Participants will be debriefed at 4 weeks post-consultation after completing follow-up questionnaires.
Control group
Active

Outcomes
Primary outcome [1] 334273 0
Self-reported Adherence:

Adherence will be assessed through a questionnaire specifically designed for this study. The questionnaires are open response and ask participants to approximate how often they engaged in mindful walking and progressive muscle relaxation exercises.
Timepoint [1] 334273 0
4 weeks post-consultation with the virtual health coach.
Primary outcome [2] 334452 0
Objective measures of adherence will also be obtained when participants register to a website specifically designed for this study that holds the resources for their stress management plan, and through the number of times that participants access these resources on the website.
Timepoint [2] 334452 0
4 Weeks Post-Consultation with the virtual health coach.
Secondary outcome [1] 420093 0
Trust in the virtual health coach will be assessed using an adapted version of the Checklist for Trust between People and Automation.
Timepoint [1] 420093 0
Immediately after the consultation with the virtual health coach.
Secondary outcome [2] 420094 0
Satisfaction with the virtual health coach will be assessed using an adapted version of the Scale of Patient Overall Satisfaction with Primary Care Physicians.
Timepoint [2] 420094 0
Immediately after the consultation with the virtual health coach.
Secondary outcome [3] 420095 0
Stress levels will be assessed using the Perceived Stress Scale.
Timepoint [3] 420095 0
Stress levels will be assessed at baseline and at 4 weeks post-consultation.

Eligibility
Key inclusion criteria
The present study will recruit participants aged 18 or over. Participants should be able to speak, read and write in English. Participants will also need their own connected device such as a computer, mobile phone, or tablet.

This study will be advertised within a University population, but people outside the institution may still participate. This study will be advertised to people who may perceive themselves as stressed.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they cannot be followed up in 4 weeks to complete the final questionnaires.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer.

Participants will be randomly allocated to one of two conditions: placebo-tailored and control. Randomisation will be conducted using Qualtrics software, which will ensure 77 participants receive the website link for the placebo-tailored consultation and 78 participants the website link for the control consultation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size for this study was calculated using G*Power software. With a power level of .80 and an alpha level of .05, this software calculated that a total sample size of 140 is required to find an effect size of d = 0.48. The present research is novel, and thus, estimates of expected effect size were challenging. The expected effect size of d = 0.48 is based on data from a previous study using the placebo tailoring method (Bashyam et al., 2020). Clark et al. also observed a similar effect size in their investigation of self-reported adherence to negotiated treatment plans in a sample of women with asthma (2012). This study will recruit 15 additional participants to accommodate potential drop-outs or missing data. Therefore 155 participants will be recruited.

The present study will use IBM SPSS software to analyse quantitative data.
Independent t-tests will be conducted for all primary outcome measures (i.e. trust, satisfaction, adherence data from the website and self-reported adherence) to identify differences between the control and experimental groups. A mixed ANOVA analysis will be conducted to compare stress levels evaluated at baseline and follow-up across both groups.
Results will be considered statistically significant if p-values are less than .05. The results will be analysed and reported as described in the consolidated standards of reporting trial (CONSORT) guidelines to maintain transparency.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2023
Actual
2/06/2023
Date of last participant enrolment
Anticipated
1/08/2023
Actual
28/10/2023
Date of last data collection
Anticipated
1/09/2023
Actual
12/12/2023
Sample size
Target
155
Accrual to date
Final
163
Recruitment outside Australia
Country [1] 25349 0
New Zealand
State/province [1] 25349 0
Auckland

Funding & Sponsors
Funding source category [1] 313503 0
University
Name [1] 313503 0
University of Auckland
Country [1] 313503 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
85 Park Road, Grafton, Auckland 1023
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 315231 0
University
Name [1] 315231 0
University of Auckland
Address [1] 315231 0
85 Park Road, Grafton, Auckland 1023
Private Bag 92019
Auckland 1142
Country [1] 315231 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312659 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 312659 0
Ethics committee country [1] 312659 0
New Zealand
Date submitted for ethics approval [1] 312659 0
22/03/2023
Approval date [1] 312659 0
12/04/2023
Ethics approval number [1] 312659 0
AH25691.

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125458 0
Dr Elizabeth Broadbent
Address 125458 0
Department of Psychological Medicine
The University of Auckland
85 Park Road, Grafton
Private Bag 92019
Auckland 1142
Country 125458 0
New Zealand
Phone 125458 0
+64 09 373 7599
Fax 125458 0
Email 125458 0
[email protected]
Contact person for public queries
Name 125459 0
Elizabeth Broadbent
Address 125459 0
Department of Psychological Medicine
The University of Auckland
85 Park Road, Grafton
Private Bag 92019
Auckland 1142
Country 125459 0
New Zealand
Phone 125459 0
+64 09 373 7599
Fax 125459 0
Email 125459 0
[email protected]
Contact person for scientific queries
Name 125460 0
Elizabeth Broadbent
Address 125460 0
Department of Psychological Medicine
The University of Auckland
85 Park Road, Grafton
Private Bag 92019
Auckland 1142
Country 125460 0
New Zealand
Phone 125460 0
+64 09 373 7599
Fax 125460 0
Email 125460 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18869Ethical approval    Attached PDF. 385600-(Uploaded-13-04-2023-13-28-14)-Study-related document.pdf
18870Study protocol    Attached PDF. 385600-(Uploaded-13-04-2023-13-28-45)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.