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Project: Using transcranial magnetic stimulation to treat postpartum depression

Project number: 28202

Dr Shane Costello
Faculty of Education
Monash University
Email: shane.costello@monash.edu

Ms Maddison Huddle
Master of Educational and Developmental Psychology
Doctor of Philosophy Candidate
Email: maddison.huddle@monash.edu

Why were you invited for this research?

Nearly 20% of women experience postpartum depression (or also known as postnatal depression; PPD) within the first three months after delivering their baby. Psychotherapy is typically the first treatment option for women with PPD, however it is often not effective, particularly so for severe cases. You were invited to participate in this research because your General Practitioner believes you may be experiencing PPD, and feels that TMS would be a suitable treatment option for you.

What does the research involve?

This study seeks to investigate the use of TMS in treating depression for women in the postpartum period. Participants will have an initial assessment with their treating psychiatrist to explain the TMS process. Participants will then undergo 30 TMS treatments, which will take a total of six weeks (typically one treatment per weekday). At every tenth treatment, participants will complete self-report and clinician-rated measures, and will have a review meeting with their treating psychiatrist. Participants progress will be observed by completing the following psychological inventories throughout the course of their TMS treatment:

  • Beck Depression Inventory (BDI)
  • Hamilton Anxiety Rating Scale (HAM-A)
  • Clinician Outcomes in Routine Evaluation (CORE-OM)
  • Edinburgh Postnatal Depression Scale (EPDS)
  • Quality of Life Scale (QOLS)

Participants will have a review meeting two weeks after their final treatment to review their progress, and also undertake periodic reviews over several months. Participants do not need a treating psychiatrist prior to being involved in the research project. A psychiatrist from the NeuroCentrix team will be allocated to each participant. Free childminding service will be provided to participants if needed.

Consenting to participate in the project and withdrawing from the research

Participants will have an initial assessment with a treating psychiatrist. During that meeting the participant will receive a consent form that outlines the study and explains the process of TMS treatment, which will be explained to them by the psychiatrist. On the day the participant is scheduled to commence TMS treatment, they will receive another copy of the consent form, which will be explained to them by the TMS clinician and confirm that the participant understands the study and treatment process before starting TMS treatment.

Participants have the right to stop being a part of the research study at any time without explanation, however participants data will be required to be stored for a minimum of seven years at NeuroCentrix Research Institute in accordance with the Heath Records Act 2001 (Vic). If the participants have any questions as a result of reading this explanatory statement, they are able to contact the research team for more information.

Possible risks to participants

Participants may experience some localised discomfort (such as headache or mild skin irritation) when receiving transcranial magnetic stimulation (TMS). More severe adverse effects are exceptionally rare, and these risks will be discussed by the consultant psychiatrists with participants prior to commencement to ensure informed consent.

TMS has already been demonstrated to be safe and effective for treating depression, and is approved by the Therapeutic Goods Administration for the treatment of depression. Recently TMS has also been approved for use under the Medicare benefits schedule. Participants will be under the clinical care of psychiatrists and psychologists, and will have access to all therapeutic and psychopharmacological alternatives as required.

Benefit to participants

The benefits to the participants in the current study is that they will receive a course of transcranial magnetic stimulation (TMS) under the care of a multidisciplinary team of psychiatrists and psychologists. There will be no cost for participant’s involvement in the research project. All TMS treatments will be free, and psychiatrist appointments will be bulkbilled under Medicare.

Confidentiality

Identifiable clinical records will be stored securely at NeuroCentrix patient management system, in accordance with the Heath Records Act 2001 (Vic). Monash University will have access to coded clinical notes of the participants.

Storage of data

Data collected will be stored in accordance with Monash University Regulations, for a minimum of five years. All data will be kept on a password protected University computer and it will only be accessed by the researchers. At the end of this period and when no longer required, data will be destroyed through the deletion of electronic data files. Records stored at NeuroCentrix will be retained for a minimum of seven years in accordance with the Heath Records Act 2001 (Vic), and will be securely deleted when no longer required to be stored.

Use of data for other purposes

If the opportunity for further projects arises, only aggregate de-identified data will be used for such projects and only where ethics approval has been granted.

Results

Findings of this study may be submitted for publication in professional publications, academic journals or conferences. Given the anonymous nature of the data, individual participants will not be identifiable in such publications. A summary of the study results can be provided to participants at the completion of the research project. Participants are to email Dr Shane Costello or Maddison Huddle if they would like to obtain a summary of the research results.

Disclosure of interest

Professor David Barton has a direct financial interest in NeuroCentrix TMS Pty. Ltd trading as NeuroCentrix TMS (NeuroCentrix), namely as a director and shareholder of NeuroCentrix. Accordingly, Professor David Barton is to be regarded as holding a personal financial interest in any transactions or arrangements you make with NeuroCentrix including the participation in TMS as conducted by NeuroCentrix.

Complaints

Should you have any concerns or complaints about the conduct of the project, you are welcome to contact the Executive Officer, Monash University Human Research Ethics (MUHREC):

Executive Officer
Monash University Human Research Ethics Committee (MUHREC)
Room 111, Chancellery Building E,
24 Sports Walk, Clayton Campus
Research Office
Monash University VIC 3800

Tel: +61 3 9905 2052

Email: muhrec@monash.edu

Fax: +61 3 9905 3831

Please contact the following counselling services if you are in need of support.

  • Lifeline: 13 11 14
  • Beyond Blue: 1300 224 636
  • PANDA National Helpline: 1300 726 306

Thank you,

Dr Shane Costello and Maddison Huddle