Screening

Welcome!

Please read the information statement about the myNewWay study below. If you would like to participate, click NEXT PAGE at the bottom of the information statement and select "I agree" on the next page when asked for your consent. After this, you'll complete a 20-minute survey to confirm your eligibility for the study.

ONLINE PARTICIPANT INFORMATION STATEMENT AND CONSENT FORM

1. What is the research study about?

You are invited to take part in this research study. The research study will evaluate the effects of a new smartphone app, myNewWay, developed by the Black Dog Institute for improving anxiety symptoms, in two formats: a blended care format where the app is used together with psychological therapy sessions, and a self-guided format where the app is used without mental health professional support.

2. Who is conducting this research?

The study is being carried out by the following researchers from the Black Dog Institute and UNSW Sydney.

Professor Jill Newby (Chief Investigator)
Associate Professor Alexis Whitton
Dr Melissa Black
Dr Rosemaree Miller
Dr Kayla Steele
Dr Ann Martin
Emily Upton
Justin Catania
Alisha Shaikh
Monique Holden
Kate Maston

Research Funder: This research is being funded by the Black Dog Institute and the National Health and Medical Research Council of Australia.

3. Inclusion/Exclusion Criteria

Before you decide to participate in this research study, we need to ensure that it is ok for you to take part. The research study is looking to recruit people who meet all the following criteria:

Score above 10 on the Distress Questionnaire 5-item (DQ-5; part of the screening questionnaire);
Meet diagnostic criteria for a DSM-5 Anxiety Disorder;
18 years or over;
Currently residing in Australia;
Fluent in English;
Have a mobile number and email address;
Owns a smartphone device with a supported operating system (Apple: iOS 13 released 1999 or newer; Android: 7.0 released 2016 or newer);
Either not currently taking medication for anxiety and/or depression OR are on a stable dose of medications for anxiety and/or depression (no new medications or changes in the past 8 weeks).

Participants who meet one or more of the following criteria will be excluded from the study:

Under 18 years of age (as this study is focused on evaluating a program for adults);
Acutely suicidal (as alternative support options may be more helpful);
Experiencing a psychotic disorder (as alternative support options may be more helpful);
You are currently receiving psychological therapy.

4. Do I have to take part in this research study?

Participation in this research study is voluntary. If you do not want to participate, you do not have to. If you decide to take part and change your mind, you can withdraw from the study at any stage. If you decide you want to take part in the research study, you will be asked to:

Read the information statement carefully (ask questions if necessary);
Complete the consent form online if you decide to participate in the study;
Download a copy of this form to keep.

5. What does participation in this research require, and are there any risks involved?

If you agree to participate, you will be asked to complete the following research procedures:

Screening procedures:

Online screening questionnaire: A screening questionnaire asking about your study eligibility, mental health, demographics and technology use. Completing the screening questionnaire will take approximately 30 minutes and will be administered to you on an online platform. If the screening questionnaire shows that you meet the criteria for inclusion, then you will proceed to the phone interview. If the screening questionnaire shows that you cannot be part of the research project, a webpage will notify you of your exclusion and include the research team contact details for further information and the details of support services if you are feeling distressed.

Phone interview: The research team will contact you to book a time and date to complete a 30-minute phone interview with a member of the research team and supervised by a clinical psychologist or clinical psychology registrar. The interviewer will confirm your eligibility for the study using information provided during your screening questionnaire and ask questions about your mental health. If the phone interview confirms your study eligibility, the psychologist will let the research team know, and the research team will send you the first online survey. If the phone interview shows that you cannot be part of the research project, the psychologist will notify you about the reasons why and provide the details of support services if you are feeling distressed.

During the online screening questionnaire and the phone interview, you will be informed that you need to provide the contact details of your general practitioner. The research team will keep these details in a password-protected file and only contact the general practitioner in the event of an emergency (e.g., suicidal crisis). The research team will also encourage you to discuss the study with your general practitioner, and they can provide a support letter outlining the details of the study for you to give to your general practitioner upon request.

Study procedures

Online surveys: Online surveys will be administered four to five times, depending on the group you are randomly assigned to for the study. Each survey should take between 20 to 30 minutes to complete. You will receive up to three follow-up SMS and email reminders to complete each survey. The first online survey will include questions about your mental health and mental health treatment. At the end of the first survey, you will be randomised to one of three groups (blended care, self-guided, usual care control group; more information below).

If you are allocated to the blended care or self-guided group, you will be asked to complete surveys 6, 12 and 24 weeks after completing the first study survey. If you are allocated to the control group, you will be asked to complete surveys 6, 12, 18 and 24 weeks after completing the first study survey.

Randomisation: The aim of the research is to compare the outcomes of using the myNewWay app alongside therapy and the usual care control group. To ensure that each participant has an equal chance of being placed in any group, a computer will randomly allocate each participant into a group, like the flip of a coin, at the end of the first online study survey. Once randomised, participants will be allocated to one of three groups:

Treatment group 1 (Blended care): This group will receive access to the myNewWay app for the whole duration of the study (24 weeks) and complete up to 10 therapy sessions with a psychologist during the first 12 weeks of the study.
Treatment group 2 (Self-guided): This group will receive access to the myNewWay app for the whole study duration (24 weeks).
Usual care control group: This group will receive access to the myNewWay app after 12 weeks (after completing the third study survey).

An overview of the differences in research procedures that you will be asked to complete in the three groups is described in the table below.

Blended Care Group	Self-guided Group	Usual Care Control Group
Therapy sessions: 10 sessions over 12 weeks	Therapy sessions: No sessions	Therapy sessions: No sessions
myNewWay app: Access for the entire study (24 weeks)	myNewWay app: Access for the entire study (24 weeks)	myNewWay app: Accessafter the third survey (12 weeks)
Online surveys: Four (baseline, 6-week, 12-week, 24-week)	Online surveys: Four (baseline, 6-week, 12-week, 24-week)	Online surveys: Five (baseline, 6-week, 12-week, 18-week, 24-week)

Intervention: The myNewWay app, which is used to support the treatment of anxiety and depression, will be used in this research. The research team designed the app through an extensive consultation process with Australians with a lived and living experience of anxiety and/or depression. myNewWay was also evaluated in a previous clinical trial and was found to be safe and useful when used in combination with therapy delivered by a psychologist.

If you need help with the myNewWay app during the trial, you can email the research team at the study address (mynewway@blackdog.org.au). Emails are checked at least once during business days, and the research team will aim to respond to your email in 1-2 business days.

Questionnaire responses: Your responses on the surveys will be monitored by the research team during business hours, overseen by a senior psychologist. If your scores indicate signs of worsening symptoms or suicidal thinking to warrant a concern about your safety, a psychologist in the research team will arrange a check-in call with you.

Optional post-treatment interview: After the 12-week survey, up to 20 participants will be randomly selected from Blended Care and Self-guided groups (10 per group) to participate in a one-off optional online Zoom interview (30-60 minutes). The purpose of this interview will be to obtain in-depth feedback about the myNewWay program. If you are selected, the research team will send you an email invitation after you complete the 12-week survey.

Additional Costs and Reimbursement: There are no costs associated with participating in this research project. However, you will receive electronic gift cards via the GiftPay store (which can only be used in Australia) to reimburse you for the time and effort to complete study surveys; the amount allocated is estimated at $20/hour, pro rata. All participants will receive a maximum of $40 gift cards for survey completion. If Blended Care or Self-Guided participants agree to complete a post-treatment interview after the 12-week survey, they will also receive an additional $20 e-gift card. An overview of the gift vouchers received by participants is described in the table below.

	Blended Care Group	Self-guided Group	Usual Care Control Group
12-week survey	$20 gift voucher	$20 gift voucher	$20 gift voucher
18-week survey	N/A	N/A	$10 gift voucher
24-week survey	$20 gift voucher	$20 gift voucher	$10 gift voucher
Sub-Total	$40	$40	$40
Optional post-treatment interview	$20 gift voucher	$20 gift voucher	N/A

Psychological Distress: You may feel that some of the questions we ask during the study are stressful or upsetting. If you do not wish to answer a question, you may skip it and go to the next question or stop immediately. If you become upset or distressed due to participating in the research project, the research team can arrange for counselling or other appropriate support. Alternatively, several free contactable counselling and support services are included in section 9.

If at any point you are considering psychological therapy outside of the research study, you may contact the research team to discuss options and decide the best course of action for your mental health. If you decide to discontinue your study participation to engage with psychological therapy outside of the study, this will not affect your relationship with the researchers or the Black Dog Institute.

6. What are the possible benefits of taking part?

We cannot guarantee or promise that you will receive any benefits from this research; however, a possible benefit may include improvements in depression and/or anxiety in two ways. First, all participants will receive access to the myNewWay smartphone app, which is currently not publicly available. The app is specifically designed to help people with symptoms of anxiety and depression, and includes content informed by Cognitive Behavioural Therapy, a first-line treatment for anxiety. Second, participants allocated to the blended care group will also receive 10 sessions of Cognitive Behavioural Therapy from a registered psychologist.

7. What are the alternatives to taking part in the research?

You do not have to take part in this research project. Other options are available, including:

Visiting your GP for a referral to a mental health professional, such as a psychologist
Black Dog Institute offers digital tools for your mental health that can be found on the Digital tools & apps page of their website

The psychologist who completes your phone interview will discuss these options with you before you decide whether to take part in this research project. You can also discuss the options with your local GP or mental health professional. The main way this study differs from other treatments for anxiety is that it tests a model of care where digital tools and therapy delivered by a psychologist are “blended” together, rather than delivered or used separately.

8. What will happen to information about me?

You will be asked to consent to participate in the research online. By clicking the ‘I agree’ button on the consent webpage, you consent to the research team collecting and using your information for the research study. The research team will store the data you provide for this research project for a minimum of 15 years after the research results are published. The information about you will be stored in a re-identifiable format where any identifiers such as your name, address, or date of birth will be replaced with a unique code.

You will be asked to provide your consent for the research team to share or use the information collected from you in future research that will be an extension of, or closely related to, the original project. Your information will only be shared in a format that will not identify you. Information collected from you in an electronic format stored on a UNSW password protected OneDrive only accessible to the approved research investigators.

Audio recordings will be stored on a UNSW password protected OneDrive only accessible to the approved research investigators and will be made available to a professional transcription service. Recordings will only be made available after a confidentiality agreement has been signed.

The information you provide is personal information for the purposes of the Privacy and Personal Information Protection Act 1998 (NSW). You have the right of access to personal information held about you by the University, the right to request correction and amendment of it, and the right to make a complaint about a breach of the Information Protection Principles as contained in the PPIP Act. Further information on how the University protects personal information is available in the UNSW Privacy Management Plan.

9. How and when will I find out what the results of the research study are?

The research team intend to publish and report the results of the research in a range of publications, presentations and on the Black Dog Institute website. All information will be published in a way that will not identify you. If you want to receive a copy of the results, you can let the research team know by entering your email into the consent form (online PISCF only). We will only use these details to send you the research results.

10. What if I want to withdraw from the research study?

If you do consent to participate, you may withdraw at any time. You can do so by completing the ‘Withdrawal of Consent Form’, which is provided at the end of the PDF version of this document, and emailing this to mynewway@blackdog.org.au, or you can contact the research team and tell them you no longer want to participate. Your decision not to participate or to withdraw from the study will not affect your relationship with UNSW Sydney or Black Dog Institute. If you decide to leave the research study, the researchers will not collect additional information from you. You can request that any identifiable information about you be withdrawn from the research project.

11. What if I have a complaint or any concerns about the research study and will I receive compensation if suffer any injuries or have complications?

If you suffer any complications because of this research project, you should contact the study team as soon as possible and you will be assisted with arranging appropriate mental health treatment. If you are eligible for Medicare, you can receive any mental health treatment required to treat the complication, free of charge, as a public patient in any Australian public hospital.

Complaints Contact
If you have a complaint regarding any aspect of the study or the way it is being conducted, please contact the UNSW Human Ethics Coordinator:

Position: UNSW Human Research Ethics Coordinator

Telephone: + 61 2 9385 6222

Email: humanethics@unsw.edu.au

HC Reference Number: iRECS8609

12. What should I do if I have further questions about my involvement in the research study?
The person you may need to contact will depend on the nature of your query. If you require further information regarding this study or if you have any problems which may be related to your involvement in the study, you can contact the following member/s of the research team:

Trial Coordinator
Name: Dr Rosemaree Miller

Position: Senior Project Officer

Telephone: (02) 9065 9354

Email: rosemaree.miller@blackdog.org.au

Chief Investigator
Name: Professor Jill Newby

Position: Professor & NHMRC investigator

Telephone: (02) 9065 9108

Email: j.newby@unsw.edu.au

Support Services Contact Details

If at any stage during the study, you become distressed or require additional support from someone not involved in the research, please call:

Name/Organisation: Beyond Blue

Telephone: 1300 224 636

Webchat: https://www.beyondblue.org.au/get-support/talk-to-a-counsellor/chat

Name/Organisation: Lifeline Australia