Participant Information Statement
  • University of Newcastle
  • Aspen Medical
  • Defence Health
  • NIER
  • CBMHR
  • NHMRC
  • Ironside Recruitment

SHADE

The SHADE Project

An internet-delivered, evidenced-based treatment program for mental health and alcohol use in contemporary Veterans.

The SHADE project is run by the Centre for Brain and Mental Health Research (CBMHR) at the University of Newcastle in conjunction with the NHMRC Centre for Research Excellence in Mental Health and Substance Use (CREMS).

The SHADE project has been designed to help us work out what level of treatment works best for contemporary veterans with symptoms of depression and hazardous alcohol use. What we know from the research already is that more does not necessarily equal better, and that people in different age groups and situations do better with different types (face-to-face versus internet delivered) and lengths (fewer or greater number of sessions) of treatment. The SHADE project is aiming to test the effectiveness of an innovative, internet delivered evidence-based psychological treatment for improving depression and hazardous alcohol use (SHADE) with the addition of a social networking component (BreathingSpace).

Part of the data collected from this study will contribute to a PhD thesis being undertaken by Mr Jake Jubelin at the University of Newcastle, who is being supervised by Associate Professors Frances Kay-Lambkin and Carole James, and Ms Katrina Streatfeild, also at the University of Newcastle, who is being supervised by Associate Professor Frances kay-Lambkin and Dr Sally Hunt.

What is involved?

To start with, we would like you to complete an online assessment which asks about your experiences (both past and current) with alcohol and/or other drug use and your experiences with depression. We would also like to ask you some basic demographic information, information about what health services you use and some general information about your quality of life. Answering these questions the first time is likely to take around an hour, at a time convenient to you. We will also ask you for information on how to contact you over the course of the study and we will ask you to provide the name, address and telephone number of someone we can call if you move and who you agree will be able to tell us your new contact details.

Once the initial assessment is completed, you will be randomly allocated to either:

  • SHADE: a group that has access for 12 weeks to a 10-session program of web-based intervention (SHADE) for hazardous alcohol use and depressed mood.
  • SHADE + BreathingSpace: a group that and has access for 12 weeks to a 10-session program of web-based intervention (SHADE) for hazardous alcohol use and depressed mood and has access for the same 12 weeks to a purpose built social networking site (BreathingSpace).

Given this is a research project, you will not be able to choose which treatment group you are allocated to.

The 10-session program of web-based intervention for hazardous alcohol use and depressed mood (SHADE) consists of information and interactive components, including case vignettes and in-session exercises which you can access via the internet on a computer or your phone. It will give you tips for reducing alcohol consumption and for improving your mood. This treatment program covers the relationship between alcohol and depression and aims to teach you to cope with your desire to drink, how to recognise and avoid high-risk situations for drinking, and how to plan alternative ways of coping with those situations where you usually drink. There are ten treatment modules that we encourage you to complete at a rate of one module per week. However, you will have access to the program and be able to review the material and information for a 12-week period. The treatment uses cognitive behaviour therapy (CBT) and motivational interviewing techniques. CBT is an evidence-based psychological treatment that targets problematic patterns of thinking, feeling and behaving that may be associated with an increase in drinking and depression symptoms. We hope to learn whether this new treatment program is able to assist young people who experience depression and binge drinking reduce their drinking and improve their mood.

The social networking site (BreathingSpace) will be similar to a Facebook group (except that it will be anonymous) enabling people to post their thoughts, messages of support, update their status, tell their stories, share self-assessment results, and report on progress related to their mood and alcohol use (successes and challenges). Only people in the research project allocated to this condition will have access to this site.

Your consent will be sought for a follow-up internet delivered assessment scheduled to occur at the conclusion of the 12 weeks access to SHADE, where you will be asked similar questions to the initial assessment. After 12 weeks you will also have the option to be interviewed over the phone by a member of the research team. This interview will ask about your experience of online e-mental health in general and about the SHADE and BreathingSpace applications in particular.

The results of each of these assessments will be recorded against your unique ‘participant number’ that has been allocated to you for the project. No personally identifying information will be linked with your participant number (as indicated in the ‘How will we use your information’ section below).

How will we use your information?

Any information that is obtained in connection with this study and that can be identified with you will remain confidential and will be disclosed only with your permission, except as required by law and departmental policy. If you give us your consent to participate in the study, we plan to discuss/publish the results at Scientific Conferences and in peer reviewed scientific journals. In any publication, information will be provided in such a way that you cannot be identified.

The person interviewing you, the person coordinating the project, and a research team involving people from the Centre for Brain and Mental Health Research (the University of Newcastle) will have access to your information.

At the start of the project, you will be given a numeric ‘participant’ number. All information that you provide for this project will only be identified by this number. Your name, address etc. information will be removed from this information. Your personal information will be accessed, used and stored in accordance with Commonwealth Privacy Laws and the NSW Health Records and Information Privacy Act 2002. Your answers to questions will be transmitted over a secure connection similar to that used for online banking. While it is possible to decode these messages, it is highly unlikely.

You will be given the option to receive an email summarising your own results from the assessment and/or summary feedback on the overall results of the project when they become available. At no time will your individual results be released to anyone other than you. There will be a section on the Consent Form asking you about your preference for receiving feedback should you wish to participate in the study.

Risks and Discomforts

There is some risk that modifying alcohol use will be associated with withdrawal symptoms and an exacerbation of symptoms of depression. In fact, if your alcohol use if high there are also some medical risks, and we advise seeking medical advice before making any changes to your current alcohol use. However, these symptoms will be monitored throughout your study participation via the completion of your online monthly self-monitoring of depression symptoms and alcohol use. In an effort to avoid an increase in your alcohol or any depression symptoms, information will be provided to you outlining how and where to obtain further support. The research clinicians associated with the project will also monitor your progress on a regular basis.

If you are in a crisis situation or need immediate assistance please use the Lifeline telephone counselling service, Ph: 131114; http://www.lifeline.org.au/. Lifeline offers online support and counselling, so please access their website if you prefer this option.

If you are concerned about feelings or thoughts of suicide, a 24-hour service is available to help. The website for more information is: http://www.suicidecallbackservice.org.au/ or Ph: 1300 659 467. This organisation also provides a call back service, offering crisis counselling to people at risk of suicide, carers for someone who is suicidal, and those bereaved by suicide.

Below are some other online resources that you may find helpful:

For concerns about your drinking, please consult your doctor or local community health service. Alcohol or other drug helplines are also currently available in the following states and territories.

  • Australian Capital Territory
    24-hour Alcohol and Drug Telephone Line
    (02) 6207 9977
  • New South Wales
    Alcohol and Drug Information Service
    (02) 9361 8000
    1800 422 599 (rural)
  • Northern Territory
    Alcohol and Drug Information Service
    1800 131 350 (NT only)
    Darwin (08) 8922 8399
    Alice Springs (08) 8951 7580
  • Queensland
    Alcohol and Drug Information Service
    1800 177 833 (24-hour, Queensland only)
  • South Australia
    Alcohol and Drug Information Service
    1300 131 340 (SA only)
    Adelaide (08) 8363 8618
  • Tasmania
    24-hour Alcohol and Drug Information Service
    1800 811 994
  • Victoria
    DirectLine 1800 888 236
    DrugInfo 1300 858 584
    Family Drug Helpline 1300 660 068 (VIC only)
    Youth Drugs and Alcohol Advice 1800 458 685
  • Western Australia
    Alcohol and Drug Information Service
    (08) 9442 5000
    1800 198 024 (rural WA only)
    Parent Drug Information Service
    (08) 9442 5050
    1800 653 203 (rural WA only)

If you would like to contact the SHADE Project team at any stage, please do so via email: info@vshade.com.au. Your email will be answered within 72 hours. If you prefer to be contacted by telephone, please provide your preferred phone number in your email to the team, and a SHADE team member will telephone you within 72 hours of receipt of your email message. For emergency situations (e.g. concerns about suicidality), or for assistance at any time of the day or night, please phone the Lifeline support service on 13 11 14 or the Suicide Call Back Service on 1300 659 467.

Termination of involvement in the project

Whether or not you take part in the project, your relationship with the University of Newcastle and/or the organisation who invited you to participate in the study will be unaffected. If you decide to take part in this project, you can withdraw from the study at any time without giving a reason. Should you decide to discontinue your participation in the project at any time, you may do so by notifying a member of the research staff. If you decide to withdraw from the study, it will not affect your future relationship with the University of Newcastle.

Your answers will be completely confidential and any personal details, which may identify you in any way, will not be passed to the Department of Veterans' Affairs. Your answers will not in any way affect any pension, benefits or health services which you are entitled to from DVA, or to which you may become entitled in the future. If you wish, you can discontinue your participation in this study at any time.

If you decide to withdraw from the project, you have the option of also withdrawing all data relating to you. An exception to this is in the case of an adverse event, or a serious adverse event, where the data needs to be retained for regulatory reporting.

We cannot and do not promise that you will receive any benefits from this project.

You will be given a copy of this form to keep.

We would also like to ask you whether we may contact you over the next five years about further research projects. If you agree to be contacted, this does not mean that you have to take part in any future studies. You can decide that at the time. During the consent process, you will have the opportunity to agree or disagree with this option, without it affecting your participation in the current study or your relationship with the University of Newcastle.

If you have any questions at any time or would like to request a summary of results, please contact me directly by email Email: frances.kaylambkin@newcastle.edu.au.

signature

A/Prof Frances Kay-Lambkin
Psychologist
Senior Research Fellow
The University of Newcastle

Research Team

The research team for this project includes:

  • A/Prof Carole James, The University of Newcastle
  • Dr Jane Rich, The University of Newcastle
  • Dr John Shepherd, Next Practice Health
  • Dr Doug Randell, Aspen Medical
  • Dr Sally Hunt, The University of Newcastle
  • Dr Ross Tynan, Hunter Institute of Mental Health
  • Ms Jenny Geddes, The University of Newcastle
  • Ms Kathryn Woodcock, Black Dog Institute
  • Mr Jake Jubelin, The University of Newcastle
  • Ms Katrina Streatfeild, PhD Candidate, The University of Newcastle

Complaints

In the first instance, a complaint about this study should be directed to A/Prof Frances Kay-Lambkin as the Principal Researcher of the project. Frances can be contacted by email: frances.kaylambkin@newcastle.edu.au or by phone: (02) 49216023. If the situation remains unresolved, the complaint should be directed to the University of Newcastle Human Research Ethics Committee within the University of Newcastle via The Senior Human Research Ethics Officer: human-ethics@newcastle.edu.au or Ph: (02) 49216333. Complaints may also be directed to the Chair of the DVA HREC via:

DVA HREC Secretariat
Department of Veterans’ Affairs
PO Box 9998
CANBERRA ACT 2600
ethics.committee@dva.gov.au

Any complaint you make will be investigated promptly and you will be informed of the outcomes. Your decision whether or not to participate will not prejudice your future relations with The University of Newcastle. If you decide to participate, you are free to withdraw your consent and to discontinue participation at any time without prejudice.