Information Sheet for Participants

Enrolment for this trial was completed in 2009, however, the Information Sheet for participants is given below for your interest. A list of sources of help and information can be found here.

Thank you for considering this invitation to take part in this study. Please read this Information Sheet carefully before deciding whether or not to participate. If you decide to participate we thank you. If you decide not to take part there will be no disadvantage to you of any kind and we thank you for considering our request. This trial should not be considered to be a substitute for professional advice for treatment for depression or anxiety.

In order to decide whether you should agree to be part of this study, you should understand enough of its risks and benefits to make an informed judgment. This process is known as informed consent.

This Information Sheet gives you information about the research study. Once you understand the study, and if you wish to participate, you will be asked to access the study web site and electronically sign an Informed Consent Form. A copy of this form will be available for your records. A diagram is available to help you understand this process.

Aim of the Study

A proven web-based self-help programme for depression is being tested for New Zealand conditions in this study. The programme includes: cognitive behaviour therapy and information about depression. The programme is designed to help people with symptoms of depression by providing relevant information and/or working through a number of exercises on the internet. To 'test' how well this programme works, a trial will be undertaken with at least 700 people.

If you agree to participate in this trial you will be directed to the study's web site and asked to read further information about the study, complete a set of 'screening' questions, carefully consider the Consent Form, and sign the Consent Form online. You will be able to print copies of these documents for your own records.

Screening Process

To ensure the study has the mix of people needed, those who are interested in participating are taken through what is called a 'screening process'. You will answer a number of questions which will identify whether the programme we have developed might help you.

Once you have signed the Consent Form, you will be given a unique identification number to take part in this study.

Then you will be directed to complete a set of Census questions and a separate set of questions on depression. In addition we would also like you to complete questions on anxiety, alcohol use, self-harm, and quality of life. All this will be done on the internet.

Later you will be randomly (that is by chance) assigned to one of three groups on the internet. Each of the three groups will complete slightly different exercises online over four weeks, which are described below.

We will also ask you a brief set of questions on your views about taking part in such studies.

The Online Exercises for the Three Groups

Cognitive Behaviour Therapy Group

You will be asked to complete three web-based modules related to your feelings, thoughts, and relationships. These modules involve completing a number of 'homework exercises', an assessment, an interactive game and feedback form. They focus on the development of coping skills for trigger events and situations. You will complete a different module each week for three weeks and review the material in the fourth week.

Depression Literacy Group

You will be provided with information about symptoms of depression, sources of help, information about medical, psychological and alternative/lifestyle treatments for depression and its prevention. You will be directed to read different information each week for three weeks and review the material in the fourth week.

Health Coach Group

You will answer online open-ended questions on physical and artistic activities, hobbies and educational activities, social support, relationships, financial management, work stress and relationships, health, nutrition and alcohol intake over three weeks and review the material in the fourth week.

Gathering Information

Trained interviewers will make weekly online contact with you over the four weeks to answer queries and monitor progress.

You will complete the above online exercises over four weeks. After this at intervals of 5 weeks, 6 months, 12 months, 18 months and 24 months you will be contacted online to answer questions on depression, related mental health, and quality of life in recent times. These questions will be completed within a week and will require you to spend between 30 and 60 minutes online. At 12 months some people in the Cognitive Behaviour Therapy group may receive a 'booster' session.

After the study has been evaluated at the end of 24 months, participants in the Health Coach Group will have an opportunity to complete either of the Depression Literacy or Cognitive Behaviour Therapy programmes.

Reporting

The results of the study will be published and summaries will be available to you on request and posted on the study web site http://www.otago.ac.nz/rid. No individuals will be identified. If you wish to have your own individual results, these will be made available to you after we receive a signed letter of request from you. Updates on the study are also expected to be posted on the study web site and we encourage you to visit the study web site regularly.

Security of Data and Confidentiality

The raw data collected will be securely stored in both electronic media and paper forms and accessible only to members of the research group, members of the University of Otago Web Office and server administrators.

All participants' data will be identified only by a unique identification number and kept strictly confidential.

At the end of the study any personal information will be destroyed immediately except that, as required by the University's research policy, any raw data on which the results of the study depend will be retained in secure storage for five years, after which it will be destroyed.

What You Might Get Out of It

You may find that taking part in this trial provides you with information or techniques that you may find helpful in your daily life for managing your mental health and well-being.

Your Rights

Please be aware that you may decide not to take part in this study without any disadvantage to yourself of any kind.

As well, you may withdraw from taking part in this study at any time and without any disadvantage to yourself of any kind. You will not be asked to give a reason for withdrawing if you do not want to.

Any Questions?

We want to make sure you understand the study and so if you have any questions about this study, either now or in the future, please feel free to contact us at our study's email address: RIDauto@ipru.otago.ac.nz.

If you have any questions or concerns about your rights as a participant in this research study you can contact an independent health and disability advocate. This is a free service provided under the Health and Disability Commissioner Act.

 

Nationwide Health and Disability Advocacy Service

Free Phone; 0800 555 050
Free Fax:  0800 2787 7678 (0800 2 SUPPORT)
Email: advocacy@hdc.org.nz

Research Group Members

Dr Shyamala Nada-Raja, Professor Rob McGee, Professor John Langley, Dr Dannette Marie, Professor Helen Christensen, Professor Andrew Mackinnon (from the University of Otago, Te Runanga o Nga Maata Waka, Christchurch, and the Australian National University, Canberra).

 

This project has been reviewed and approved by the Multi-Region Ethics Committee, reference no. MEC/07/05/066 and the Australian National University's Human Research Ethics Committee, protocol number 2007/2295.

University of Otago Recovery via the Internet from Depression Research Study