Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001092886
Ethics application status
Approved
Date submitted
23/06/2021
Date registered
18/08/2021
Date last updated
22/12/2021
Date data sharing statement initially provided
18/08/2021
Date results information initially provided
22/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study for delivering self-care strategies for psychological distress in university students using a smartphone app.
Scientific title
Delivering self-care strategies for psychological distress in university students using a smartphone app: A pilot study in preparation for an AI-response-adaptive randomised controlled non-inferiority trial.
Secondary ID [1] 304044 0
Nil known
Universal Trial Number (UTN)
U1111-1267-0053
Trial acronym
Linked study record
This study served as the pilot for 'Using AI to investigate the effectiveness of smartphone delivered self-care strategies for psychological distress in university students' (ACTRN: 12621001223820; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12621001223820)

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 321676 0
Condition category
Condition code
Mental Health 319421 319421 0 0
Anxiety
Mental Health 319422 319422 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot study will include a 10-day baseline measurement period incorporating questionnaire batteries on Day 1 (baseline) and Day 10 (mid-point), plus Ecological Momentary Assessment (EMA) from Day 1 to Day 9.

The intervention period is for a duration of 14 days. All interventions in this study will be delivered via a smartphone app. Each study participant will receive one study intervention, once, over a period of 2 weeks. Interventions are self-administered.

Each arm of the trial is administered via a common mobile app. During the intervention period, participants will only have access to the intervention that have been allocated to. All of the app content has been designed specifically for this study. Participant are instructed to complete tasks within the app each day, however the time spent interacting with the app is at their discretion (however, see below for suggested time spent engaging with intervention activities). Adherence to the interventions will be measured by accessing app analytics (i.e. module completion, number of times mindfulness audio is played, number of times physical activity goal for the day is registered), and self-reported log of engagement with the intervention (i.e. daily log of time spent practising mindfulness, being physically active, or sleeping).

Arm 1 Mindfulness

The mindfulness intervention starts with an introductory video (3 minutes), followed by five guided mindfulness practices delivered as audio recordings (3-5 minutes in duration each). The five guided mindfulness practices are: 1) Mindful breathing, 2) Unhooking from thoughts, 3) Body scan, 4) Mindful eating, and 5) Mindful walking.
The introductory video is available to participants immediately after allocation to the intervention. The first mindfulness audio guide becomes available immediately after the introductory video has been completed. The subsequent mindfulness audio guides are sequentially released, at one day intervals (regardless of participant engagement).

Participants are expected to complete minimum one mindfulness exercise daily at their convenience and for all modules to be completed at least once by end of treatment period.

Arm 2 Physical activity

The physical activity intervention starts with an introductory infographic, then prompts participants to choose a goal each day to increase their physical activity that day. The introductory infographic demonstrates benefits of physical activity, Australian guidelines for physical activity, setting realistic goals, and tips to increase physical activity. For the daily goal setting, participants can choose to increase their step count, follow an evidence-based 7-minute HICT workout, engage in other activities such as social sport, gardening, yoga etc., or opt for a rest day. Participants can review the introductory infographic and goal setting information as many times as they please throughout the intervention, however new/additional information will not be presented as the intervention period proceeds.

The HICT protocol includes the following exercises: Jumping jacks, Wall sit, Push up, Abdominal crunch, Step up onto a chair, Squat, Tricep dip on chair, Plank, High knees, Lunge, Pushup and rotation, Side plank.

Participants will be invited to complete a daily log of physical activity (i.e. number of minutes they spent increasing their physical activity throughout the day). Participants will not receive feedback on this log during the intervention; it is intended for the research team to monitor adherence.

Time spent interacting with the app during the physical activity intervention is at the discretion of the participant and depends on the physical activity chosen for each day; however, participants are expected to log their activity and set a goal each day, which is expected to take at minimum approximately 3 minutes. It is expected that physical activity will be completed daily at each participant’s convenience, including 7-minute work out three times weekly or, alternatively, increasing steps by 10% weekly.


Arm 3 Sleep Hygiene

The sleep hygiene intervention centres around four brief, sequential modules covering key sleep hygiene concepts which are delivered via infographics (i.e. illustrated text that participants read). Each module takes up to five minutes to read. Modules include: 1. Why sleep (benefits of sleep), 2. Sleep habits (regular wake/sleep time, reducing naps, wind down routine) , 3. Sleep environment (environmental adjustment including impact of electronics and stimulus control information), and 4. Daily activities for sleep (diet, reducing stimulants, physical activity).

The modules are made available to participants as follows: module 1 is available to participants immediately after allocation to the intervention; module 2 becomes available immediately after a participant has completed Module 1. Module 3 and Module 4 are subsequently made available at two day intervals (regardless of participant engagement).
Intervention code [1] 320434 0
Lifestyle
Intervention code [2] 320435 0
Behaviour
Comparator / control treatment
The active control condition consists of two weeks of Ecological Momentary Assessment (EMA) measurements, The control condition is also delivered via the same app as the active interventions (participants will only have access to the form to enter EMA measurements during the intervention period)

EMA involves repeated sampling of participants' current behaviours and experiences in real time, in participants' natural environment. Modified Positive and Negative Affect Schedule, Short Form (PANAS) will be used to collect EMA data. The measurement schedule will be twice daily signals (participants complete EMA in response to app generated notifications) and unlimited self-initiated measurements (participants can elect to complete EMA within the app at any point, in addition to when prompted).

It is anticipated that duration of data entry for participants in the control group will take a maxmium of 5 minutes per day.
Control group
Active

Outcomes
Primary outcome [1] 327380 0
Self-reported psychological distress as measured by Depression Anxiety and Stress Scale - 21 item version (DASS-21)
Timepoint [1] 327380 0
Mid-point (10 days after app download, following baseline EMA period and prior to intervention commencement), Post-intervention (two weeks after intervention commencement; primary time point), & 8-week follow-up (10 weeks after intervention commencement).
Secondary outcome [1] 394874 0
Productivity Costs Questionnaire; a standardised questionnaire including three modules measuring productivity losses related to paid work due to absenteeism and presenteeism, as well as productivity losses related to unpaid work.
Timepoint [1] 394874 0
8-week follow-up (10 weeks after intervention commencement).
Secondary outcome [2] 395701 0
Use of Mental Health Care Services, assessed via self-report items related to hosptilisation, outpatient services, online self-help, community based services and pharmacotherapy.
Timepoint [2] 395701 0
8-week follow-up (10 weeks after intervention commencement).
Secondary outcome [3] 395702 0
Quality of life measured by EQ-5D-5L
Timepoint [3] 395702 0
8-week follow-up (10 weeks after intervention commencement).
Secondary outcome [4] 395703 0
Level of physical activity measured by the Modified Physical Activity Vital Sign
Timepoint [4] 395703 0
Mid-point (10 days after app download, following baseline EMA period and prior to intervention commencement), Post-intervention (two weeks after intervention commencement), & 8-week follow-up (10 weeks after intervention commencement).
Secondary outcome [5] 395704 0
Sleep quality measured by Abridged Pittsburgh Sleep Quality Index
Timepoint [5] 395704 0
Mid-point (10 days after app download, following baseline EMA period and prior to intervention commencement), Post-intervention (two weeks after intervention commencement), & 8-week follow-up (10 weeks after intervention commencement).
Secondary outcome [6] 395705 0
Level of mindfulness measured by Mindfulness single item questionnaire
Timepoint [6] 395705 0
Mid-point (10 days after app download, following baseline EMA period and prior to intervention commencement), Post-intervention (two weeks after intervention commencement), & 8-week follow-up (10 weeks after intervention commencement).
Secondary outcome [7] 395706 0
GPS location data, sampled on the basis of significant location change (as defined by the underlying operating system).

Note: only for participants who do not opt-out of digital phenotyping at consent or disable the required permissions on their smartphone.
Timepoint [7] 395706 0
Day 1 -30 of the app experience. That is, from when the app is installed, through baseline EMA period, and until post-intervention is completed (2 weeks after intervention commencement).
Secondary outcome [8] 398125 0
Gravity-adjusted accelerometery (Android devices and iPhone 7 or later) and gyroscope (Android devices only) data, sampled with best-effort at 50Hz for 1 minute every 5 minutes.

Note: only for participants who do not opt-out of digital phenotyping at consent or disable the required permissions on their smartphone.
Timepoint [8] 398125 0
Day 1 -30 of the app experience. That is, from when the app is installed, through baseline EMA period, and until post-intervention is completed (2 weeks after intervention commencement).
Secondary outcome [9] 398126 0
Operating system-generated activity label plus confidence (e.g. in vehicle, walking, stationary with low/medium/high confidence), step count and total distance travelled sampled with best-effort once every 5 minutes.

Note: only for participants who do not opt-out of digital phenotyping at consent or disable the required permissions on their smartphone.
Timepoint [9] 398126 0
Day 1 -30 of the app experience. That is, from when the app is installed, through baseline EMA period, and until post-intervention is completed (2 weeks after intervention commencement).
Secondary outcome [10] 398127 0
Device power state and battery percentage, sampled with best effort once every 5 minutes.

Note: only for participants who do not opt-out of digital phenotyping at consent or disable the required permissions on their smartphone.
Timepoint [10] 398127 0
Day 1 -30 of the app experience. That is, from when the app is installed, through baseline EMA period, and until post-intervention is completed (2 weeks after intervention commencement).
Secondary outcome [11] 398128 0
Device model, make, platform and app software versions, submitted with every sensor payload.

Note: only for participants who do not opt-out of digital phenotyping at consent or disable the required permissions on their smartphone.
Timepoint [11] 398128 0
Day 1 -30 of the app experience. That is, from when the app is installed, through baseline EMA period, and until post-intervention is completed (2 weeks after intervention commencement).
Secondary outcome [12] 398129 0
Feasibility of app delivery and adherence to the interventions, measured by accessing app analytics (i.e. module completion, number of times mindfulness audio is played, number of times physical activity goal for the day is registered), and self-reported log of engagement with the intervention (i.e. daily log of time spent practising mindfulness, being physically active, or sleeping).
Timepoint [12] 398129 0
Throughout the intervention period (day 11-24 of the app experience).
Secondary outcome [13] 398130 0
Usability of the app, measured via study-specific self-report questionnaire. This 'UX questionnaire' asked participants to rate usability, usefulness and satisfaction with the app on a 5-point likert scale.
Timepoint [13] 398130 0
Post-intervention (two weeks after intervention commencement).

Eligibility
Key inclusion criteria
The key inclusion criteria are:

- 18 years or older;
- Living in Australia;
- Currently studying at an Australian university, TAFE or other higher education institution;
- Fluent in English;
- Own an up-to-date smartphone, with active mobile number and internet access; and
- Are experiencing elevated psychological distress (e.g. anxiety, stress or low mood).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The key exclusion criteria are:

- People who have reported significant thoughts of suicide in the past month, indicated by a score of greater than or equal to 21 on the Suicide Ideation Attributes Scale (SIDAS).
- People who self-report a current diagnosis of psychosis or bipolar disorder;
- People who have been previously recruited to the study (screened eligible and consented);
- People who indicate limited availability to participate in a digital intervention;
- People who indicate that any aspect of their personal circumstances would prevent them from taking part in a physical activity intervention, if allocated to receive this treatment.

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)
Participant screening and enrolment is self-directed and automated via the study website. Random allocation for each participant will be automatically assigned by the software driving the app. The app will only inform participants of their allocated condition after the baseline period is completed. The app reveals participant allocation on Day 11 (for diligent participants; Day 13 for slow participants).

Allocation concealment will be guaranteed by:

- Preventing access by blinded study staff to the computer system holding randomisation information; and
- Breaking randomization codes only once primary data analysis is complete.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be stratified by baseline Z-score normalised total DASS-21 score (discretised into 3 categorical strata according to the cut-offs specified in the DASS manual (Lovibond and Lovibond, 1995): normal-mild; moderate; severe-extremely severe), using proportionate sampling based on the sample strata sizes observed for pilot 1.

Sequence generation for random assignment within stratification blocks will be based on computer-generated random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis of primary endpoint

Planned contrasts will compare intervention arms using the post-intervention DASS-21 total scores normalised according to the procedures described in the DASS manual.

We will use a mixed-effects repeated measures (MMRM) approach. Pre-intervention normalised DASS scores will be incorporated as a predictor variable in all models. We will test the effects of including other predictors, such as demographic variables. An unconstrained variance–covariance matrix will model within-individual dependencies. Transformation of scores, including categorisation, may be undertaken to satisfy distributional assumptions and accommodate outliers.

Analysis of the primary endpoint will be based on an intention-to-treat analysis strategy, analysing all participants starting the study regardless of the intervention received, under the assumption that missing data are Missing At Random.

Additional analyses
Descriptive analyses will be used to summarise secondary outcome scores and assess compliance and attrition from the interventions . We will explore whether specific demographic or other factors are associated with differential engagement.

We will also calculate the post-hoc power obtained to detect the observed effect sizes.

Significance level

The study pre-defined significance level for comparisons, alpha, is 0.05.

Missing data

We intend to analyse all participants who start the pilot study. To qualify as having started the study, participants must install the app and complete the baseline questionnaires within the 72 hour window.

Participants who do not do this will be excluded from all study analyses.

MMRM are able to handle partial/missing data under the assumption that data are Missing At Random. The effects of excluding missing data will be assessed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/07/2021
Date of last participant enrolment
Anticipated
Actual
9/09/2021
Date of last data collection
Anticipated
Actual
8/10/2021
Sample size
Target
200
Accrual to date
Final
292
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308425 0
Government body
Name [1] 308425 0
Department of Health, Australian Government
Country [1] 308425 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
CHANCELLERY UNSW
High St Kensington NSW 2033
Country
Australia
Secondary sponsor category [1] 309259 0
None
Name [1] 309259 0
N/A
Address [1] 309259 0
N/A
Country [1] 309259 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308386 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 308386 0
UNSW Research Ethics & Compliance Support
The University of New South Wales
Sydney NSW 2052
Ethics committee country [1] 308386 0
Australia
Date submitted for ethics approval [1] 308386 0
25/01/2021
Approval date [1] 308386 0
01/02/2021
Ethics approval number [1] 308386 0
HC200466

Summary
Brief summary
This study is a pilot to inform a larger RCT that will use Artificial Intelligence (AI) and adaptive trial methods to discover the most effective treatments to provide to Australian university students, 25% of whom experience severe psychological distress and, consequently, drop out of study or go on to develop more severe psychiatric disorders in their peak years.

Both the pilot study and the planned RCT (to be registered after this pilot study) will compare app-delivered self-care intervention for psychological distress in tertiary students based on mindfulness, physical activity and sleep hygiene, with an active control condition consisting of Ecological Momentary Assessment (daily mood monitoring). The current pilot study aims to test the feasibility of the study infrastructure, including study app, intervention content, and the algorithm.
Trial website
Trial related presentations / publications
Public notes
This pilot study is being conducted to inform an upcoming pragmatically-oriented, decentralised AI-adaptive group sequential randomised controlled non-inferiority trial (RCT) comparing the effectiveness of receiving one of three brief, two week digital self-guided interventions (physical activity, mindfulness or sleep hygiene) or active control in reducing self-reported psychological distress (DASS-21 normalised total score) in Australian university students. This initial pilot aims to test the feasibility of the interventions and methodology, including acceptability and usability of the study app and suitability of the proposed trial methods.

The proposed full RCT (to be registered after the pilot study) will aim to determine whether intervention effect sizes can be identified (efficiently) using a multi-arm contextual bandit-based AI-adaptive trial method, and whether estimates are consistent with estimates derived from prior research using traditional trial methods. In addition, the full RCT will explore whether baseline severity is associated with differences in intervention effect by incorporating baseline severity into the model of intervention effectiveness developed by the AI algorithm. The RCT will proceed as a series of 12 discrete “mini-trials”, each recruiting a restricted sample of participants who are allocated to study intervention/control arms under the control of an AI algorithm. This current pilot study will run as a separate "mini-trial" that is equivalent to mini-trial 1 in the proposed full RCT. As in mini-trial 1 of the RCT, in this pilot study, participants will be allocated at random to each of the four arms with a uniform probability of 0.25 (i.e. an allocation ratio of 1:1:1:1).

Contacts
Principal investigator
Name 110534 0
Prof Helen Christensen
Address 110534 0
Black Dog Institute, Hospital Rd, Randwick NSW 2031
Country 110534 0
Australia
Phone 110534 0
+612 9065 9099
Fax 110534 0
Email 110534 0
[email protected]
Contact person for public queries
Name 110535 0
Dr Wu Yi Zheng
Address 110535 0
Black Dog Institute, Hospital Rd, Randwick NSW 2031
Country 110535 0
Australia
Phone 110535 0
+612 9065 9248
Fax 110535 0
Email 110535 0
[email protected]
Contact person for scientific queries
Name 110536 0
A/Prof Jill Newby
Address 110536 0
Black Dog Institute, Hospital Rd, Randwick NSW 2031
Country 110536 0
Australia
Phone 110536 0
+612 9065 9248
Fax 110536 0
Email 110536 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Any of the individual participant data collected during the trial, after de-identification, is potentialy available, pending review of data requests by the Study Publications Committee.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Only researchers who provide a methodologically sound proposal, following approval on a case-by-case basis at the discretion of Study Publications Committee.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by the Study Publications Committee, via the Project Manager by emailing [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11572Informed consent form    381869-(Uploaded-04-05-2021-10-43-16)-Study-related document.DOC
11573Ethical approval    381869-(Uploaded-04-05-2021-10-43-56)-Study-related document.Pdf



Results publications and other study-related documents

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