You are invited to take part in a research study involving a brief psychological treatment for depression called Cognitive Behaviour Therapy (CBT). The purpose of the study is to examine certain processes of therapy which may increase its positive benefits. The study will involve 70 individuals between the age of 18 and 65 years, recruited within the greater Auckland area. Like yourself, these individuals will currently be experiencing a major depressive episode for the first time. Before you consent to be part of this study, please read the following. Ask as many questions as you need to be sure that you understand what taking part will involve. The decision to take part is entirely your choice.
If you provide written consent to be involved, you will receive a comprehensive psychological assessment, then a 20 session protocol of CBT for depression over a 16 week period. Treatment will be individualised based on your specific needs and goals, and provided by advanced clinical psychology trainees under close supervision. Consistent with prior research on CBT for depression, sessions will be scheduled twice a week for the first 4 weeks and then weekly for the next 12 weeks. Follow-up sessions will occur at 2 months and 6 months after treatment has ended. Participants will be asked to complete some assessment questionnaires to determine treatment gains, and also asked to provide informal feedback on the CBT they received. Your total time commitment (assessment, therapy sessions, questionnaires, and follow-up) is estimated to be about 30 hours, plus travel to and from the Centre for Psychology. Therapy will be provided by clinical psychology doctoral/masters students trained in delivering this protocol.
How will the study benefit you? It is expected that new information, which may benefit
you or others, will be obtained by this study. Furthermore, it is very likely that the comprehensive psychological assessment and therapy offered as part of this study will improve your condition, although this cannot be guaranteed. These services will be provided free of charge. Due to funding limitations, you will be responsible for your own travel costs to and from the Centre for Psychology in Albany. Parking will be provided free of charge.
Who is unable to take part? Participants will need to be proficient in reading, writing,
nervous system. They must not meet diagnostic criteria for substance abuse, psychosis, or borderline personality disorder. Lastly, they must be able to be managed safely with outpatient psychotherapy.
If you do agree to take part, you are free to withdraw from the study at any time without having to give a reason. This will in no way affect your continuing health care, as you will be referred to an appropriate provider to further assist your specific needs. Participation in this study will be stopped should any harmful effects appear or if an appropriate medical professional feels it is not in your best interest to continue. You may be taken out of the study if you need treatment that is not allowed during this study, or if the study is cancelled. You will be asked to check with your study therapist before taking any other treatment; this includes anything from the supermarket, pharmacy or health shop.
Will my information remain confidential? Participating in this study will involve having
your therapy sessions videotaped (and transferred to DVD discs) in order for the researchers to monitor the therapy protocol. All information collected about you during the study, including the recorded sessions, will be kept strictly confidential and only accessed by those researchers and clinical supervisors directly involved in the study. The only time in which confidentiality is breached is in the event that you express an intention to harm either yourself or somebody else, in which case a crisis team would become involved. No material which could personally identify you will be used in any reports on this study. All assessment information and clinical notes will be kept in individual files stored in a locked clinical records room, with files coded with anonymous identification numbers. Files will be stored in a separate location from both the identifying information and the DVD archive.
The information collected will be used for the research project and for publication in academic journals. All participants will be offered a summary of the findings at the conclusion of the study. This will include details of any publication arrangements that have been made. Please note that there is likely to be a delay between data collection and publication.
In the unlikely event of a physical injury as a result of your participation in this study, you may be covered by ACC under the Injury Prevention, Rehabilitation and Compensation Act. ACC cover is not automatic and your case will need to be assessed by ACC according to the provisions of the 2002 Injury Prevention Rehabilitation and Compensation Act. If your claim is accepted by ACC, you still might not get any compensation. This depends on a number of factors such as whether you are an earner or non-earner. ACC usually provides only partial reimbursement of costs and expenses and there may be no lump sum compensation payable. There is no cover for mental injury unless it is a result of physical injury. If you have ACC cover; generally this will affect your right to sue the investigators. If you have any questions about ACC, contact your nearest ACC office or the investigator.
If at any time you have questions or concerns about this study, you are welcome to contact: Dr. Nikolaos Kazantzis (who now has an academic office at La Trobe University), phone:
Auckland (09) 8898292, or email: [email protected]
If you have any questions about any issues pertaining to Maori in this study, regardless of your own ethnicity, you are welcome to contact Kaumatua koro Turoa, via the School of
If you have any queries or concerns regarding 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 & Disability Commissioner Act:
Telephone (NZ wide): 0800 555 050
Free Fax (NZ wide): 0800 2787 7678 (0800 2 SUPPORT) Email: [email protected]