ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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

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]

Nil known

Universal Trial Number (UTN)

U1111-1244-3329

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anxiety

Depression

Condition category

Condition code

Mental Health

Anxiety

Mental Health

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]

Treatment: Devices

Intervention code [2]

Treatment: Other

Intervention code [3]

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]

% 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]

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]

% 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]

Secondary outcome [1]

% 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]

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]

Each participant will assess the overall quality and impressions of the app they used by completing a Mobile Application Rating Scale (MARS).

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2351 - University Of New England

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of New England

Address [1]

University of New England
Armidale, NSW, 2351

Country [1]

Australia

Primary sponsor type

University

Name

University of New England

Address

University of New England
Armidale, NSW, 2351

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Jamie Marshall

Address [1]

School of Psychology
Faculty of Medicine and Health
University of New England
Armidale NSW 2351

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of New England Human Research Ethics Committee

Ethics committee address [1]

University of New England
Armidale, NSW, 2351

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/09/2019

Approval date [1]

01/11/2019

Ethics approval number [1]

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

Prof Debra Dunstan

Address

Head of School
School of Psychology
Faculty of Medicine and Health
University of New England
Armidale, NSW, 2351

Country

Australia

Phone

+61 2 6773 3764

Fax

ddunstan@une.edu.au

Contact person for public queries

Name

Jamie Marshall

Address

PhD Candidate
School of Psychology
Faculty of Medicine and Health
University of New England
Armidale, NSW, 2351

Country

Australia

Phone

+61 412 575 185

Fax

j.marsh21@myune.edu.au

Contact person for scientific queries

Name

Jamie Marshall

Address

PhD Candidate
School of Psychology
Faculty of Medicine and Health
University of New England
Armidale, NSW, 2351

Country

Australia

Phone

+61 412 575 185

Fax

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.	Type	Email
4376	Study protocol	jmarsh21@myune.edu.au
4377	Informed consent form	jmarsh21@myune.edu.au
4378	Clinical study report	jmarsh21@myune.edu.au
4379	Ethical approval	jmarsh21@myune.edu.au
4380	Analytic code	jmarsh21@myune.edu.au
4381	Statistical analysis plan	jmarsh21@myune.edu.au

Results publications and other study-related documents

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