Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001302145
Ethics application status
Approved
Date submitted
28/08/2019
Date registered
23/09/2019
Date last updated
1/09/2021
Date data sharing statement initially provided
23/09/2019
Date results information initially provided
1/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
I bet there’s an app for that: Using mental health apps to manage anxiety and depression
Scientific title
Testing the effectiveness of five mental health apps for managing anxiety and depression: A multiple single-case design
Secondary ID [1] 299132 0
Nil known
Universal Trial Number (UTN)
U1111-1244-3329
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 314199 0
Depression 314200 0
Condition category
Condition code
Mental Health 312555 312555 0 0
Anxiety
Mental Health 312556 312556 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventions for this research consist of five mental health apps:
1. Destressify
2. MoodMission
3. Smiling Mind
4. MindShift
5. SuperBetter

All apps are freely available on the Apple App Store (for iOS devices) and Google Play (for Android devices). All participants will receive the same general instructions for using the app, no matter which app they have been assigned to: "We would like you to use this app for at least 10 mins per day, 5 days p.w. for at least 10 wks. (We will tell you when the “official” use period has finished, but you will be able to keep using the app after this time if you want to.) If you want to use it for longer than 10 mins per day and more than 5 days p.w., this is OK – it’s up to you. As long as you’re using it for at least 10 mins per day, 5 days p.w.

After participants are randomised into an app group, they will be given specific information about the app, including download instructions.

All apps have websites with further information and evidence for their effectiveness published in peer-reviewed journals as follows:

1. Destressify: Lee, R. A., & Jung, M. E. (2018).
https://www.destressify.com/

Summary of instructions given to participants: Destressify was developed in the United States and is based on a technique called mindfulness, with a focus on reducing stress. When you first open Destressify, there is the option of watching a 12-minute video about “what is stress?”. It is not essential that you watch this. If you want to skip this video, tap on the “Get Started” button. You will need to create an account by providing an e-mail address, password, and other information. Follow the instructions to do this. If you’re concerned about your data, read the privacy policy at https://www.destressify.com/privacy/ . When you have finished creating your profile, you are given the option to either “View My Plan” or “View Practices”. The View My Plan option opens the core plan of mindfulness exercises that have already been selected for you. The View Practices option allows you to create your own plan. We recommend choosing the core plan and following their suggestions. After tapping on View My Plan, you can immediately begin your first mindfulness activity. In the Menu, tap on the button “Practices” to read information on the different types of activities available in the app.

2. MoodMission: Bakker, D., Kazantzis, N., Rickwood, D., & Rikkard, N. (2018).
http://moodmission.com/

Summary of instructions given to participants: MoodMission was developed in Australia by a team of psychologists and mental health researchers at Monash University, and uses a technique called cognitive-behaviour therapy (CBT). You will need to create an account by providing an e-mail address and password. Follow the instructions when you open the app for the first time after downloading it, and take the time to answer the questionnaire – it helps the app choose appropriate activities for you. If you’re concerned about your data, read the privacy policy at http://moodmission.com/privacy. MoodMission works by asking you questions about how you are feeling, and suggests all types of activities in response to how you answer the questions. MoodMission does not make you do just one thing, but always provides different options. If you do not like any of the listed options, you have the opportunity to ask MoodMission to suggest others. At the bottom right of screen is the “Expeditions” button. Tap on this to find suggested programs for overcoming specific fears e.g. fear of public speaking, fear of flying etc.

3. Smiling Mind: Flett, J. A. M., Hayne, H., Riordan, B. C., Thompson, L. M., & Conner, T. S. (2018).
https://www.smilingmind.com.au/

Summary of instructions given to participants: Smiling Mind was developed in Australia by mental health and meditation experts and is based on a technique called mindfulness, with a meditation focus. You will need to create an account by providing an e-mail address and password. Follow the instructions when you open the app for the first time after downloading it. If you’re concerned about your data, read the privacy policy at https://www.smilingmind.com.au/privacy-policy . After you have created an account, tap on the “All Programs” tab at the top right of screen. This will give you a list of all the programs available within the app. We recommend that you use the “Adult Programs” to start with because this consists of the greatest variety of activities. Once in “Adult Programs”, feel free to scroll down the page and start using any of the programs by tapping on it. (Our recommendation is to start at the top first, and then work your way down through the programs.)

4. MindShift: Paul, A. M., & Fleming, C. J. E. (2019).
https://anxietycanada.com/resources/mindshift-cbt/

Summary of instructions given to participants: MindShift was developed in Canada by a not-for-profit mental health support organisation and uses a technique called cognitive-behaviour therapy (CBT). Although its focus is anxiety, the techniques can be applied to depression as well. You will need to create an account by providing an e-mail address, password, and other information. If you’re concerned about your data, read the privacy policy at: https://anxietycanada.com/mindshift-cbt-privacy-policy/ . After you have created an account, the app opens to its home screen. The Home screen allows you to choose how you are feeling today, and what type of anxiety you suffer from. Tapping on a type of anxiety takes you to information about that type of worry. When you scroll down the anxiety screen, the app allows you to select categories within that type of anxiety which lists some of the more common unhelpful thoughts associated with it. We recommend that you start by scrolling down the home page until you come to “Tools”. Tap on the button, “Healthy Thinking”, then tap on “Thought Journal”, and then tap on “Add New +”. This will get you started using one of the main functions of the app: coming up with more helpful thoughts when you are feeling anxious and/or depressed due to thinking negatively.

5. SuperBetter: Roepke, A. M., Jaffee, S. R., Riffle, O. M., McGonigal, J., Broome, R., & Maxwell, B. (2015).
https://www.superbetter.com/

Summary of instructions given to participants: SuperBetter was developed in the United States by game designer Jane McGonigal and researchers at Stanford University and the University of Pennsylvania. It uses techniques from positive psychology and neuroscience (neuroplasticity). You will need to create an account by providing an e-mail address and password. Follow the instructions when you open the app for the first time after downloading it, and take the time to answer the questions – it helps the app choose appropriate activities for you. If you’re concerned about your data, read the privacy policy at https://www.superbetter.com/terms. A good place to start with SuperBetter is to tap on the “More” button at the bottom right of screen, then tap on “FAQ”, and read the entire FAQ section. It provides an excellent background to how SuperBetter works and will get you ready to start “playing” immediately. SuperBetter uses the idea of playing a video game and works by getting you to complete “quests”. Quests are activities designed to get you closer to achieving your specific goals. “Power-ups” are smaller activities designed to make you feel better and improve your mood quickly. After you have read the FAQ section, we recommend that you tap on the “SB To do” button at the bottom centre of screen, then tap the “Do 3 Quests” banner, then tap the “Hero, Start Here!” button.

* Daily SUDS ratings provided by participants will be monitored by the lead researcher who is an experienced clinical psychologist. If low ratings indicate a risk of harm, the researcher will contact the participant. If a participant provides no rating for 7 days, the researcher will attempt to contact the participant.
* As is normal in this type of research, the pre-intervention phase is designed to establish a baseline set of readings for the participant. The 3-week post-intervention phase is to allow readings of participants' distress levels following the official intervention period in order to determine if there are increases in distress or if intervention readings are maintained. This is also to allow the statistical procedure of time-series analysis. The final 6-month period does not require the participants to do anything.
Intervention code [1] 315408 0
Treatment: Devices
Intervention code [2] 315409 0
Treatment: Other
Intervention code [3] 315410 0
Behaviour
Comparator / control treatment
No control group. The aim of this research is not to compare apps by trying to find if one is more effective than the other. However, we wish to leave open the possibility of indicating if one or more of the apps are not effective compared to any other apps that are.
Control group
Active

Outcomes
Primary outcome [1] 321209 0
% change in depression score for both the Depression Anxiety Stress Scale (DASS-21) and the Outcome Questionnaire (OQ-45). A daily Subjective Units of Distress (SUDS) rating will be obtained that will also provide a measure of depression for comparison with the other outcome measures. Level of clinical significance in % change will be calculated using the framework suggested by Jacobson & Truax (1991), and Jacobson et al. (1999). These will result in a composite primary outcome of depression level for each participant.
Timepoint [1] 321209 0
There are five timepoints in total: Commencement, then a minimum of 3 weeks to Pre-Intervention, then 10 weeks to Post-Intervention, then 3-Week Follow-Up, and 6-Month Follow-up. Analyses will be conducted from one timepoint to the next, as well as an overall measure from Commencement to 6-Month Follow-Up, which is the primary timepoint. It is this final analysis that is of most interest from Commencement to 6-Month Follow-Up because this will provide an indication of the long-term effects of the intervention.
Primary outcome [2] 321210 0
% change in anxiety score for both the Depression Anxiety Stress Scale (DASS-42) and the Outcome Questionnaire (OQ-45). A daily Subjective Units of Distress (SUDS) rating will be obtained that will also provide a measure of anxiety for comparison with the other outcome measures. Level of clinical significance in % change will be calculated using the framework suggested by Jacobson & Truax (1991), and Jacobson et al. (1999). These will result in a composite primary outcome of anxiety level for each participant.
Timepoint [2] 321210 0
There are five timepoints in total: Commencement, then a minimum of 3 weeks to Pre-Intervention, then 10 weeks to Post-Intervention, then 3-Week Follow-Up, and 6-Month Follow-up. Analyses will be conducted from one timepoint to the next, as well as an overall measure from Commencement to 6-Month Follow-Up, which is the primary timepoint. It is this final analysis that is of most interest from Commencement to 6-Month Follow-Up because this will provide an indication of the long-term effects of the intervention.
Secondary outcome [1] 374321 0
% change in stress score for both the Depression Anxiety Stress Scale (DASS-42) and the Outcome Questionnaire (OQ-45). A daily Subjective Units of Distress (SUDS) rating will be obtained that will also provide a measure of stress for comparison with the other outcome measures. Level of clinical significance in % change will be calculated using the framework suggested by Jacobson & Truax (1991), and Jacobson et al. (1999). These will result in a composite secondary outcome of stress level for each participant.
Timepoint [1] 374321 0
There are five timepoints in total: Commencement, then a minimum of 3 weeks to Pre-Intervention, then 10 weeks to Post-Intervention, then 3-Week Follow-Up, and 6-Month Follow-up. Analyses will be conducted from one timepoint to the next, as well as an overall measure from Commencement to 6-Month Follow-Up. It is this final analysis that is of most interest from Commencement to 6-Month Follow-Up because this will provide an indication of the long-term effects of the intervention.
Secondary outcome [2] 374691 0
Each participant will assess the overall quality and impressions of the app they used by completing a Mobile Application Rating Scale (MARS).
Timepoint [2] 374691 0
This will occur at the completion of the Intervention phase.

Eligibility
Key inclusion criteria
Inclusion criteria: Must be over 18 years of age. Must have a smartphone or tablet device capable of downloading the app, and able to send daily Subjective Units of Distress (SUDS) ratings to the Student Researcher. Must be experiencing mild to moderate symptoms of anxiety and/or depression, according to a self-report inventory and verified by the Student Researcher (who is an experienced Clinical Psychologist).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: Must not be suffering from severe anxiety or depression. Must not have a diagnosis of psychosis, or other complex mental illness.

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)
The randomisation process will occur without intervention from the researcher by using a computer program (Research Randomizer) to randomly assign participants to an app.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (Research Randomizer).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This research is using a multiple baseline across-subjects design. As well as using visual interpretation of statistical graphs over time, clinical significance will be calculated using the framework proposed by Jacobson & Truax (1991) and Jacobson et al. (1999). A time series analysis will also be calculated using the "R" statistical software package. Minimum participant numbers do not apply using this research design, however, we have decided to use at least five participants in each intervention because Barlow et al. (2009) has indicated if 3-5 replications of a single case design produce similar results, then this is a reliable indication of the intervention's capabilities with other individuals who share similar characteristics to those of the study's participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/10/2019
Actual
2/12/2019
Date of last participant enrolment
Anticipated
1/12/2019
Actual
29/01/2020
Date of last data collection
Anticipated
30/09/2020
Actual
2/12/2020
Sample size
Target
25
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 27685 0
2351 - University Of New England

Funding & Sponsors
Funding source category [1] 303673 0
University
Name [1] 303673 0
University of New England
Country [1] 303673 0
Australia
Primary sponsor type
University
Name
University of New England
Address
University of New England
Armidale, NSW, 2351
Country
Australia
Secondary sponsor category [1] 303777 0
Individual
Name [1] 303777 0
Jamie Marshall
Address [1] 303777 0
School of Psychology
Faculty of Medicine and Health
University of New England
Armidale NSW 2351
Country [1] 303777 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304195 0
University of New England Human Research Ethics Committee
Ethics committee address [1] 304195 0
University of New England
Armidale, NSW, 2351
Ethics committee country [1] 304195 0
Australia
Date submitted for ethics approval [1] 304195 0
02/09/2019
Approval date [1] 304195 0
01/11/2019
Ethics approval number [1] 304195 0
Approval Number HE19-186

Summary
Brief summary
Only a small proportion of available mental health apps have any research backing up claims of efficacy. The present research will use a methodology that will provide timely results using a rigorous scientific process in a manner that can potentially offer valuable information prior to running larger randomised controlled trials, and/or enrich the results of larger randomised controlled trials. This research will also add to the paucity of independent research that currently exists in this area, something that has been called for in the literature. This research is important, because the advent of efficacious mental health apps has the following potential benefits: portability and accessibility (having immediate access to help any time); a convenient way of doing homework activities from face-to-face sessions; ability to set reminders for any number of things, e.g. taking medication; people on waiting lists for face-to-face services may be able to get help via a mobile app; increased anonymity; improved access to treatment for people in rural and remote areas; access difficult to reach groups such as teenagers; and reduce the burden on primary care health services.

Research questions/aims/objectives/hypothesis:
1. Do the apps in this study provide clinically significant improvements in symptoms of anxiety and/or depression?
2. What individual characteristics of participants influence the results in this regard?
3. Are there any characteristics of the apps themselves that may influence the results?

We will examine a total of five mental health apps for their effectiveness in reducing symptoms of anxiety and/or depression. All apps have published evidence of their effectiveness in peer-reviewed journals, and all five are freely and publicly available in the major app stores for both iOS and Android devices.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96110 0
Prof Debra Dunstan
Address 96110 0
Head of School
School of Psychology
Faculty of Medicine and Health
University of New England
Armidale, NSW, 2351
Country 96110 0
Australia
Phone 96110 0
+61 2 6773 3764
Fax 96110 0
Email 96110 0
ddunstan@une.edu.au
Contact person for public queries
Name 96111 0
Jamie Marshall
Address 96111 0
PhD Candidate
School of Psychology
Faculty of Medicine and Health
University of New England
Armidale, NSW, 2351
Country 96111 0
Australia
Phone 96111 0
+61 412 575 185
Fax 96111 0
Email 96111 0
j.marsh21@myune.edu.au
Contact person for scientific queries
Name 96112 0
Jamie Marshall
Address 96112 0
PhD Candidate
School of Psychology
Faculty of Medicine and Health
University of New England
Armidale, NSW, 2351
Country 96112 0
Australia
Phone 96112 0
+61 412 575 185
Fax 96112 0
Email 96112 0
jmarsh21@myune.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification, will be available to researchers who are conducting meta-analyses and replication studies. This will occur only after these researchers' identities and affiliations have been verified.
When will data be available (start and end dates)?
After publication of any article that reports on results from this research. This is likely to occur around the 1st September 2020 at the earliest. There is no end date.
Available to whom?
Data collected during the trial, after de-identification, will be available to researchers only after these researchers' identities and affiliations have been verified. Only the researchers directly involved in this research will have initial access to the password-protected data, who will then forward on data if the above criteria is met.
Available for what types of analyses?
Meta-analyses and replication studies by individuals whose identity and affiliation is verified.
How or where can data be obtained?
By contacting the corresponding researcher, Mr Jamie Marshall.
E-mail: jmarsh21@myune.edu.au
Postal Address:
School of Psychology
Faculty of Medicine and Health
University of New England
Armidale NSW 2351


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4376Study protocol  jmarsh21@myune.edu.au
4377Informed consent form  jmarsh21@myune.edu.au
4378Clinical study report  jmarsh21@myune.edu.au
4379Ethical approval  jmarsh21@myune.edu.au
4380Analytic code  jmarsh21@myune.edu.au
4381Statistical analysis plan  jmarsh21@myune.edu.au



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.