Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001333101
Ethics application status
Approved
Date submitted
13/09/2019
Date registered
30/09/2019
Date last updated
30/09/2019
Date data sharing statement initially provided
30/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Headstrong 21 Day Stress Detox: An exploration of the feasibility and acceptability of a chatbot (conversational agent) as a tool to reduce stress and increase well-being in young adults (age 18-24)
Scientific title
Headstrong 21 Day Stress Detox: A feasibility and engagement open trial exploring the use of a chatbot (conversational agent) to reduce stress and increase well-being in young adults (age 18-24)
Secondary ID [1] 299208 0
Nil Known
Universal Trial Number (UTN)
U1111-1239-7736
Trial acronym
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Stress 314317 0
Anxiety 314401 0
Condition category
Condition code
Mental Health 312668 312668 0 0
Other mental health disorders
Mental Health 312978 312978 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 21 Day Stress Detox is a digital intervention that sits on the HABITs (Health Advances through Behaviour Intervention Technologies) platform - a digital ecosystem developed by the University of Auckland to manage a body of research around the use of digital technologies for mental health support.
Participants on the 21 Day Stress Detox are directed to this platform, where they first register, then consent electronically to the study and proceed to complete baseline measures. Participants are then instructed (via a link) on how to activate the chatbot using their Facebook Messenger.
The chatbot consists of 21 days-worth of structured dialogues. Each day the chatbot initiates a new activity by sending the participant a message (e.g. "hi {participant name}, how's it going?"). The chatbot provides new content each day. The content of the intervention is steeped in cognitive behavioural (CBT) framework that includes relaxation, problem solving, identifying and challenging negative thoughts. Additionally interpersonal skills (communication, negotiation, assertiveness) are also part of the program. The focus of the intervention is to teach positive coping skills to manage stressful situations better.
Each engagement is designed to last around 5 minutes each day.
There are 3 stages covered over the 21 days, based on a CBT 3 component model:
1. Feelings - self monitoring, bodily sensation awareness, relaxation techniques
2. Thinking - cognitive re-appraisal & challenging negative thoughts
3. Behaviour - structured problem solving, positive communication, activity scheduling & systematic desensitisation for fearful situations.
Content is linked throughout to practical goal setting. A daily prompt encourages a growth mindset through gratitude journaling.
Content is delivered in short, easy to digest segments of psycho-education followed by examples and activities for participants to practice.
Participants are free to use the chatbot as much or as little as they choose during the 21 day period, usage data will be accessed via the HABITs platform to analyse adherence.
Intervention code [1] 315503 0
Treatment: Other
Comparator / control treatment
No control group - open trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321319 0
The primary aim of this study is to determine whether a Chatbot (conversational agent) for emotional wellbeing is engaging for young adults. Exploration of engagement will be a composite primary outcome measured via usage data, satisfaction ratings and free text feedback from participants.
Usage data is collected for the duration of the 21 day intervention period. When a participant is interacting with the chatbot, the HABITs IT platform uses the HABITs API to send usage information to researchers - date when the chatbot was initiated, frequency of use, when the tool is used (time and date stamp), which activities/days are completed.
A scale developed for this study will be used as a satisfaction rating: 7 questions on a 5 point Likert scale, followed by an overall rating on a scale of 0 - 10. Text feedback from participants will be collected post intervention, and analysed qualitatively for themes around engagement, using Braun & Clarke's (2006) thematic analysis methodology.
Timepoint [1] 321319 0
Post-intervertion: 3-4 weeks after intervention commencement
Secondary outcome [1] 374751 0
Changes in self-reported stress levels after completion of treatment compared with baseline using the Perceived Stress Scale (PSS)
Timepoint [1] 374751 0
Baseline
Post-intervertion: 3-4 weeks after intervention commencement
Secondary outcome [2] 374752 0
Changes in self-reported anxiety levels after completion of treatment compared with baseline using the Generalized Anxiety Disorder 7-item (GAD-7) scale
Timepoint [2] 374752 0
Baseline
Post-intervertion: 3-4 weeks after intervention commencement
Secondary outcome [3] 374753 0
Changes in self-reported wellbeing after completion of treatment compared with baseline using the WHO (Five) Wellbeing Index (WHO-5)
Timepoint [3] 374753 0
Baseline
Post-intervention: 3-4 weeks after intervention commencement
Secondary outcome [4] 374754 0
Changes in self-reported wellbeing after completion of treatment compared with baseline using the Personal Wellbeing Measure (ONS4)
Timepoint [4] 374754 0
Baseline
Post-intervention: 3-4 weeks after intervention commencement
Secondary outcome [5] 374755 0
Estimate of changes in self-reported stress level using momentary assessments within the chatbot conversation.

A daily momentary assessment is carried out in the form of a simple likert scale (quantified on a scale from 0-10) to collect self-report on perceived stress. Through the secure connection to our HABITS IT server, this information is collected from the chatbot to the HABITS platform/database.
Timepoint [5] 374755 0
Evaluation of trends in individual stress levels across intervention duration (21 days)

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion if:
•They are aged 18-24 years of age (on the day of consent);
•They have access to a smart phone, tablet or Chromebook (Android, iOS)
•They have a Facebook Messenger account
Minimum age
18 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We have a target sample size of 40 for this study. Power calculations are not deemed necessary due to this being an open engagement and acceptability trial. We expect that a sample size of 40 participants should provide sufficient information to determine acceptability and to benchmark engagement.

Descriptive summaries including means, medians, ranges and standard deviations, frequencies and percentages will be used to describe chatbot usage behaviour and responses provided in the chatbot rating scale. These descriptive summaries will be estimated for the number of times the chatbot is accessed and the frequency/adherence over the 3 weeks.

Descriptive data, including means and standard deviations, will be used to analyse the within-chatbot Likert scales and the wellbeing measures. Changes over time will be estimated by calculating effect sizes for the Likert scales, wellbeing, stress and anxiety measures.
The secondary outcomes will be summarised for the all participants completing these scales, using within-subject paired sample t-tests. Although this is an exploratory study, it is still possible to make the null hypothesis assumption that there is no difference between measures at baseline and post intervention.
Analysis of results from this study will also look at estimation based on effect size and confidence intervals. For example, data will be visually represented using scatter plots of individual data points, mean differences will be represented with confidence interval bars.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/10/2019
Actual
Date of last participant enrolment
Anticipated
30/11/2019
Actual
Date of last data collection
Anticipated
30/12/2019
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 21854 0
New Zealand
State/province [1] 21854 0
Auckland

Funding & Sponsors
Funding source category [1] 303752 0
Government body
Name [1] 303752 0
Ministry of Business, Innovation and Employment
Country [1] 303752 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Research Office
University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 303867 0
None
Name [1] 303867 0
N/A
Address [1] 303867 0
N/A
Country [1] 303867 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304270 0
Auckland University Human Participants Ethics Committee
Ethics committee address [1] 304270 0
Ethics committee country [1] 304270 0
New Zealand
Date submitted for ethics approval [1] 304270 0
22/05/2019
Approval date [1] 304270 0
18/06/2019
Ethics approval number [1] 304270 0
023234

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

Contacts
Principal investigator
Name 96358 0
Dr Karolina Stasiak
Address 96358 0
Dept of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland
Bldg 599, Level 12, Room 12005
2 PARK RD
GRAFTON
AUCKLAND 1023
Country 96358 0
New Zealand
Phone 96358 0
+64 9 923 3890
Fax 96358 0
Email 96358 0
[email protected]
Contact person for public queries
Name 96359 0
Ruth Williams
Address 96359 0
Dept of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland
Bldg 599, Level 12, Room 12005
2 PARK RD
GRAFTON
AUCKLAND 1023
Country 96359 0
New Zealand
Phone 96359 0
+64 21 1312283
Fax 96359 0
Email 96359 0
[email protected]
Contact person for scientific queries
Name 96360 0
Ruth Williams
Address 96360 0
Dept of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland
Bldg 599, Level 12, Room 12005
2 PARK RD
GRAFTON
AUCKLAND 1023
Country 96360 0
New Zealand
Phone 96360 0
+64 21 1312283
Fax 96360 0
Email 96360 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
Maintenance of participant privacy


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4770Informed consent form    378325-(Uploaded-13-09-2019-08-18-33)-Study-related document.pdf
4771Ethical approval    378325-(Uploaded-13-09-2019-08-19-58)-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.