Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000678392
Ethics application status
Approved
Date submitted
8/05/2017
Date registered
12/05/2017
Date last updated
12/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Magnetic Resonance Spectroscopy of Post Traumatic Stress Disorder.
Scientific title
Magnetic Resonance Spectroscopy to Document Alterations to Neurochemistry Associated with Post Traumatic Stress Disorder.
Secondary ID [1] 291876 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Traumatic Stress Disorder 303169 0
Condition category
Condition code
Mental Health 302632 302632 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Volunteers who decide to participants will need to sign and return the Consent Form prior to the commencement of the following sequential study procedures:

Telephone Screen
Upon receipt of a signed Consent Form the participants will be contacted by the research nurse who will conduct a telephone screen to check your initial eligibility for the study. This telephone screen will be carried out at a time convenient to you and will take approximately 30 minutes.

During this telephone screen the research nurse will ask you questions relating to your current medications, previous history of any mental health condition, previous history of injuries to your head or neck and past medical history.

Online Survey
If the research nurse confirms that you meet the initial eligibility to continue in the study you will be asked to complete an online survey. This survey will be sent by email to you for you to complete. Your name will not appear on the survey it will be replaced with a unique participant number. This survey will ask you more in-depth questions about your previous medical history including any history of depression and/or anxiety, any drug and alcohol use, previous head injury and/or pain. You will be asked to complete the survey on your own and it is expected to take you approximately 30 minutes.

The research nurse or study psychologist will contact you soon after you have completed the online survey to discuss any queries or concerns that may have arisen for you as a result.

Psychological Assessment
If you are confirmed to be eligible to continue to participate in the psychological assessment, an appointment will be made for you with the study’s clinical psychologist. In this study the researchers prefer this assessment to be carried out face-to-face, However, we recognise that this may not possible for all participants because of the distance they are from the study site. For participants who are unable to attend a face-to-face interview, which will be conducted in the Clinical Research Facility at the Princess Alexandra Hospital, than the clinical psychologist will conduct this assessment via Skype or telephone at an appointed time.

The clinical psychologist will perform the psychological assessment using a structured interview process which includes the completion of questionnaires. The WebNeuro cognitive assessment that will be required to be complete online assesses your motor tapping, choice reaction time, verbal memory-recall and digit span. This assessment takes approximately 30 – 60 minutes to complete.

If you are confirmed to be unsuitable to continue participation in the study during this assessment then the clinical psychologist will inform you of this either during or after your assessment. If you require further clinical follow up or require ongoing psychological support, the study psychologist will provide a written referral to your local doctor or alternatively refer you to the public mental health care system closest to you.

Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy
If you are confirmed to be eligible to proceed on to have the imaging of your brain then the research nurse will arrange an appointment visit for you at one of the following facilities:

- Herston Imaging Research Facility, Royal Brisbane and Women’s Hospital campus, Bowen Bridge Road, Herston
- Princess Alexandra Hospital Medical Imaging Department, Ipswich Road, Woolloongabba
- Hunter Medical Research Institute Imaging Centre, John Hunter Hospital campus Newcastle, Lookout Road, Newcastle

During your visit to the imaging facility you will be required to undergo two non-invasive imaging procedures with a clinical scanner used for routine testing. Your two scan procedures will be done in a single visit on the same day with a short break in between.

For the 1st MRS scan you will be require to lie in the scanner for approximately 40 minutes. During this scan images of your brain and information on its chemistry will be obtained.

The 2nd MRI scan is a functional MRI and will assess the blood flow in different areas of your brain. This scan will take approximately 45 minutes. These are additional MR scans which you would not be undergoing unless you were part of the study.
Intervention code [1] 297995 0
Diagnosis / Prognosis
Comparator / control treatment
A healthy control group will be used throughout this study. Healthy controls are volunteers who do not meet criteria for Post Traumatic Stress Disorder.
Control group
Active

Outcomes
Primary outcome [1] 302024 0
To explore the possibility of neurochemical markers of confirmed PTSD using Magnetic Resonance Spectroscopy.
Timepoint [1] 302024 0
You will be booked in for your MRI/MRS imaging at the earliest convenience. Imaging is completed within four weeks of your enrolment into the study. There is no requirement for any follow up imaging.
Secondary outcome [1] 334675 0
To ascertain the differences in neurochemistry between individuals with confirmed PTSD and healthy controls using Magnetic Resonance Spectroscopy.
Timepoint [1] 334675 0
Data Analysis will be completed within a 3 year timeframe.

Eligibility
Key inclusion criteria
PTSD Cohort - Inclusion Criteria
-Diagnosis of PTSD made according to the DSM-V

Healthy Control Cohort - Inclusion Criteria
-N previous diagnosis of PTSD
-No history of psychiatric illness
-No chronic medical conditions
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Current substance use disorder.
-Lifetime history of substance dependence.
-Current diagnosis of Major Depressive Disorder, Schizophrenia, Psychosis or Bipolar disorder.
-History of childhood trauma such as abuse
-Previous history of head injury or loss of consciousness (significance of this will depend on when the injuries occurred – will be assessed with questionnaire).
-Use of benzodiazepines; anticonvulsants; mood stabilisers within the last 4 weeks of MR scan.
-Contraindication to MRI scanning including shrapnel or any mental implants.
-Current pregnancy.
-History of meningitis.
-History of a chronic serious medical condition.
-History of chronic inflammatory disease.
-Structural brain injury or abnormality.
-Neurological disorders.
-High dependency on medical care.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
30 PTSD participants are required with 30 age and gender matched healthy controls.

Analysis of biochemical markers will be achieved via measuring chemical peaks on the Magnetic Resonance Spectroscopy images and compared with healthy controls.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
30/11/2016
Date of last participant enrolment
Anticipated
1/03/2018
Actual
Date of last data collection
Anticipated
1/03/2018
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 7942 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 7943 0
John Hunter Hospital - New Lambton
Recruitment hospital [3] 7944 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 15912 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 15913 0
2305 - New Lambton
Recruitment postcode(s) [3] 15914 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 296377 0
Government body
Name [1] 296377 0
Australian Department of Defence
Country [1] 296377 0
Australia
Primary sponsor type
Other
Name
Translational Research Institute
Address
36 Kent St
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 295323 0
None
Name [1] 295323 0
Address [1] 295323 0
Country [1] 295323 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297614 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 297614 0
Ethics committee country [1] 297614 0
Date submitted for ethics approval [1] 297614 0
13/07/2016
Approval date [1] 297614 0
27/10/2016
Ethics approval number [1] 297614 0
HREC/16/QPAH/522
Ethics committee name [2] 297615 0
Australian Defence Research Ethics Committee
Ethics committee address [2] 297615 0
Ethics committee country [2] 297615 0
Date submitted for ethics approval [2] 297615 0
Approval date [2] 297615 0
10/07/2014
Ethics approval number [2] 297615 0
Protocol 732-16

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1701 1701 0 0
/AnzctrAttachments/372884-Clean PICF_MRS of PTSD 5 0_Oct 2016.pdf (Participant information/consent)
Attachments [2] 1702 1702 0 0
/AnzctrAttachments/372884-Clean_PICF_MRS of PTSD_BI_MTBI 11.0_Feb 17.pdf (Participant information/consent)
Attachments [3] 1703 1703 0 0
/AnzctrAttachments/372884-Metro South HREC Approval 26_11_15.pdf (Ethics approval)
Attachments [4] 1704 1704 0 0
/AnzctrAttachments/372884-Clean_Protocol_MRS 2.0 June 2016.pdf (Protocol)
Attachments [5] 1705 1705 0 0
/AnzctrAttachments/372884-ADHREC Approval Letter_14071 732-13 Approval.pdf

Contacts
Principal investigator
Name 74594 0
Prof Carolyn Mountford
Address 74594 0
Translational Research Institute
36 Kent Street
Woolloongabba QLD 4102
Country 74594 0
Australia
Phone 74594 0
+61734437000
Fax 74594 0
Email 74594 0
[email protected]
Contact person for public queries
Name 74595 0
Lisa Rich
Address 74595 0
R-Wing
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba QLD 4102
Country 74595 0
Australia
Phone 74595 0
+61731769002
Fax 74595 0
Email 74595 0
[email protected]
Contact person for scientific queries
Name 74596 0
Graham Galloway
Address 74596 0
Translational Research Institute
36 Kent Street
Woolloongabba QLD 4102
Country 74596 0
Australia
Phone 74596 0
+61734437000
Fax 74596 0
Email 74596 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.