Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000744752
Ethics application status
Approved
Date submitted
12/05/2022
Date registered
24/05/2022
Date last updated
14/06/2023
Date data sharing statement initially provided
24/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a telehealth intervention influence levels of stress and mindfulness in university students?
Scientific title
Can a telehealth intervention influence levels of stress and mindfulness in university students?
Secondary ID [1] 307060 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 326204 0
Condition category
Condition code
Mental Health 323510 323510 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial involves the delivery of a mindfulness intervention by one of three modes of delivery: virtual human, chatbot, or human zoom delivery.

All participants come to the research centre for the first mindfulness session.

The mindfulness session is based on the Video-Conferenced Stress Management and Relaxation Training for Older Women with Breast Cancer (Antoni, 2017; VSMART) validated Mindfulness Meditation Relaxation Training intervention. This involves a preliminary question about the participants' stress level, a brief explanation of mindfulness, then approximately 12 minutes of mindfulness instructions.

In the virtual human delivery condition, participants interact with the digital human, which is an advanced form of human-like embodied conversational agent. The male digital human will appear on screen in a ‘head and shoulder’ framing while delivering the VSMART intervention by speaking it to the participant.

The chatbot group delivery will be the same except the participants interact with an online automated chatbot, which is a more basic conversational agent without human form. The same VSMART intervention is delivered in a written text delivered on the screen.

The human delivery of the session will involve the same script used by the virtual human and chatbot. To standardise the delivery format to be over a computer, the human condition will be delivered over zoom video from an adjacent room. The participant will interact with the human, who will verbally deliver the same VSMART intervention described above. This will be delivered by a male pre-intern in a University psychology training programme receiving clinical supervision from a registered psychologist.

In all groups, participants will be asked to complete 12 minute homework sessions daily (with a minimum of at least twice a week) for four weeks using a computer (8 - 28 repetitions total; 1.5 - 5.5 hours total, respectively). These sessions will be delivered using the same modality they were randomised to; i.e. those in the digital human group will have sessions from the digital human, those randomised to the chatbot have sessions from the chatbot, and those allocated to the human will have video recorded human sessions. These simply consist of the same mindfulness instructions as earlier.
Intervention code [1] 323510 0
Behaviour
Intervention code [2] 323511 0
Treatment: Other
Comparator / control treatment
The human delivery group is the active control group, as human delivery is the standard form of delivery of such interventions.
Control group
Active

Outcomes
Primary outcome [1] 331262 0
Stress as measured by the Perceived Stress Scale (Coehn, 1994)
Timepoint [1] 331262 0
Measured pre-intervention, and at the one-month follow-up (primary time point).
Secondary outcome [1] 409604 0
Stress as measured by heart rate using an Empatica E4 wristband, a research wearable.
Timepoint [1] 409604 0
During intervention at the research centre.
Secondary outcome [2] 409605 0
Homework Completion
Timepoint [2] 409605 0
Measured one-month post-intervention by self-report as the number of times per week homework was completed.
Secondary outcome [3] 409606 0
Stress as measured by galvanic skin response using an Empatica E4 wristband, a research wearable.
Timepoint [3] 409606 0
During the intervention taking place at the research centre.
Secondary outcome [4] 409607 0
Perceived Empathy - To assess participant perceptions of the human or agent’s empathy, an adapted perceived empathy scale (Johanson, 2021) will be used. Participants will be asked to rate statements such as “If I were nervous, the mindfulness therapist would make me feel calmer” on a 5-point scale anchored as ‘strongly agree’, ‘agree’, ‘neutral’, ‘disagree’, or ‘strongly disagree'. A total score will be made.
Timepoint [4] 409607 0
This will be administered directly post-intervention and at one month follow-up.
Secondary outcome [5] 409608 0
Perceptions of Personality

To assess participant perceptions of the human or agent’s personality, an adaption of Asch’s personality scale (Asch, 1946) will be used. Participants will be asked to select the descriptor they most agreed with from each of 18 different pair-choice items (e.g. happy versus unhappy, sociable versus unsociable). Asch’s personality measure has been used in both psychological and social robotics research (Broadbent et al., 2013; Mann et al., 2015; Williams & Bargh, 2008).
Timepoint [5] 409608 0
This will be administered directly post-intervention and at the one-month follow-up.
Secondary outcome [6] 409609 0
Interacting again? Participants will also be asked, “If offered the chance, would you want to interact with the therapist again?”
Timepoint [6] 409609 0
This will be administered at the one-month follow-up.
Secondary outcome [7] 409610 0
Written Feedback

Participants will be asked for a written response about what they liked and didn't like about the delivery of the mindfulness session, and how they think the delivery of the mindfulness session could be improved.
Timepoint [7] 409610 0
This will be administered directly post-intervention and at the one-month follow-up.
Secondary outcome [8] 410204 0
Stress as measured by a 100mm visual analog scale.
Timepoint [8] 410204 0
Measured directly pre- and post-intervention (of the in-person session) and at the one-month follow-up point.
Secondary outcome [9] 410205 0
Mindfulness as measured by the 15-item Five Facets of Mindfulness Questionnaire (FFMQ), a short form of the 39-item FFMQ (Baer et al., 2006).
Timepoint [9] 410205 0
Measured directly pre-intervention (in the research centre mindfulness session) and at the one-month follow-up.

Eligibility
Key inclusion criteria
All individuals over the age of 18 years who read, speak, and write fluent English will be eligible for inclusion in this study. Participants must also have access to a computer or smartphone to have access to the homework sessions. Participants must be current University students.
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 from the study if they do not fulfil the inclusion criteria, do not have access to technology that will allow them to complete the at-home homework sessions, if they have hearing difficulties or complete vision loss.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants in each arm of the study will be blinded to group allocation because knowledge of their allocation may influence and bias their responsiveness to the intervention. The PIS will state that participants will receive a mindfulness session remotely over the internet. They will not be told that there are three conditions. Participants will be debriefed along with a summary of the study findings once all statistical analyses are completed and the thesis is submitted.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blinded (masking used). A computer-generated random list will be used to allocate participants to groups by an independent party. Allocations will be placed into opaque sealed consecutively numbered envelopes. These will be opened by the researcher after the participants have signed informed consent.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A formal power calculation is appropriate and was calculated using G*Power 3.1 (Faul et al., 2009) with an ANCOVA. Using an alpha level of 0.05 and power of 0.8, along with an effect size of f=0.32 based on Huberty and colleagues’ (2019) findings investigating technology-based delivery of a mindfulness intervention. Using these parameters gives a sample size of 98 participants is required. We will add 10% to allow for attrition, to make the final sample size 108 (36 participants per group).

Descriptive statistics will be used to summarize sociodemographic information and baseline characteristics. Mixed ANOVA will examine whether the two groups vary in stress and mindfulness after the intervention and at follow-up. ANOVA will examine whether homework completion levels and perceived empathy differ between the three groups. If significant, a mediation model will be tested.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/07/2022
Actual
6/07/2022
Date of last participant enrolment
Anticipated
9/09/2022
Actual
1/09/2022
Date of last data collection
Anticipated
10/10/2022
Actual
13/10/2022
Sample size
Target
108
Accrual to date
Final
108
Recruitment outside Australia
Country [1] 24751 0
New Zealand
State/province [1] 24751 0
Auckland

Funding & Sponsors
Funding source category [1] 311364 0
University
Name [1] 311364 0
University of Auckland
Country [1] 311364 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
85 Park Road
Grafton
Auckland 1023
New Zealand
Country
New Zealand
Secondary sponsor category [1] 312817 0
None
Name [1] 312817 0
Address [1] 312817 0
Country [1] 312817 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310857 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 310857 0
Ethics committee country [1] 310857 0
New Zealand
Date submitted for ethics approval [1] 310857 0
03/05/2022
Approval date [1] 310857 0
06/05/2022
Ethics approval number [1] 310857 0
AH23988

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

Contacts
Principal investigator
Name 119114 0
Prof Elizabeth Broadbent
Address 119114 0
The University of Auckland
85 Park Road
Grafton
Auckland 1023
New Zealand
Country 119114 0
New Zealand
Phone 119114 0
+64 9 923 6756
Fax 119114 0
Email 119114 0
[email protected]
Contact person for public queries
Name 119115 0
Mariam Karhiy
Address 119115 0
The University of Auckland
85 Park Road
Grafton
Auckland 1023
New Zealand
Country 119115 0
New Zealand
Phone 119115 0
+64210437189
Fax 119115 0
Email 119115 0
[email protected]
Contact person for scientific queries
Name 119116 0
Mariam Karhiy
Address 119116 0
The University of Auckland
85 Park Road
Grafton
Auckland 1023
New Zealand
Country 119116 0
New Zealand
Phone 119116 0
+64210437189
Fax 119116 0
Email 119116 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
15945Ethical approval    384014-(Uploaded-12-05-2022-20-05-10)-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.