Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000429651
Ethics application status
Approved
Date submitted
31/03/2014
Date registered
17/04/2014
Date last updated
22/12/2021
Date data sharing statement initially provided
22/12/2021
Date results information initially provided
22/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Study of the Physical Health and Genetics of Post-Traumatic Stress Disorder (PTSD).
Scientific title
A Cross-Sectional, Case-Control Study of the Physical Health Status of Vietnam Veterans with and without Post-Traumatic Stress Disorder (PTSD) and Investigation of Genetics of PTSD.
Secondary ID [1] 284187 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
PTSD-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-Traumatic Stress Disorder 291282 0
Condition category
Condition code
Mental Health 291637 291637 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
This is an observational study investigating the physical health status of Vietnam veterans with and without Post-traumatic Stress Disorder and investigation of genetics of PTSD. The observation period is 6 weeks.
Intervention code [1] 289123 0
Not applicable
Comparator / control treatment
There is no treatment involved with this study. The control group will include Vietnam Veterans who do not have PTSD.
Control group
Active

Outcomes
Primary outcome [1] 291818 0
Clinician-Administered PTSD Scale (CAPS)
Timepoint [1] 291818 0
Following informed consent.
Secondary outcome [1] 307607 0
Coronary Artery Calcium (CAC) Score.
Timepoint [1] 307607 0
Within 6 weeks of informed consent.
Secondary outcome [2] 307888 0
Blood albumin level (g/L)
Timepoint [2] 307888 0
Within 6 weeks of informed consent.
Secondary outcome [3] 307889 0
Liver FibroScan score
Timepoint [3] 307889 0
Within 6 weeks of informed consent.
Secondary outcome [4] 307890 0
The G allele of single nucleotide polymorphism (SNP) rs386231 in the nitric oxide synthase1 adaptor protein (NOS1AP) gene.
Timepoint [4] 307890 0
Within 6 weeks of informed consent.

Eligibility
Key inclusion criteria
1. Australian males who served as members of the Australian Defence Force in Vietnam during the Vietnam War (irrespective of potential diagnosis of PTSD, or lack thereof).
2. Participants must have read and signed the Participant Information Sheet and signed the Informed Consent Form (PISICF).
3. Participants must be willing to attend GMRF-GPH for all appointments.
4. Participants must be willing to undergo medical and psychological history and clinical examination and test procedures as outlined in the PISICF.
5. Participants must reside sufficiently close to GPH to attend for the required study assessments.
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous diagnosis of schizophrenia or bipolar disorder

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Case control
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/02/2014
Actual
28/02/2014
Date of last participant enrolment
Anticipated
31/03/2015
Actual
20/07/2015
Date of last data collection
Anticipated
Actual
22/07/2015
Sample size
Target
300
Accrual to date
Final
311
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2159 0
Greenslopes Private Hospital - Greenslopes

Funding & Sponsors
Funding source category [1] 288810 0
Charities/Societies/Foundations
Name [1] 288810 0
Returned Services League (RSL) Queensland
Country [1] 288810 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Returned Services League (RSL) Queensland
Address
283 St Pauls Terrace
Fortitude Valley QLD 4006
Country
Australia
Secondary sponsor category [1] 287578 0
None
Name [1] 287578 0
Address [1] 287578 0
Country [1] 287578 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290656 0
Greenslopes Research Ethics Committee
Ethics committee address [1] 290656 0
Greenslopes Private Hospital
121 Newdegate Street
Greenslopes QLD 4120
Ethics committee country [1] 290656 0
Australia
Date submitted for ethics approval [1] 290656 0
26/09/2013
Approval date [1] 290656 0
13/11/2013
Ethics approval number [1] 290656 0
13/53
Ethics committee name [2] 310085 0
Department of Defense and Veterans' Affairs Human Research Ethics Committee
Ethics committee address [2] 310085 0
CP3-7-038 Campbell Park Offices
PO Box 7911
Canberra BC ACT 2610
Ethics committee country [2] 310085 0
Australia
Date submitted for ethics approval [2] 310085 0
12/02/2014
Approval date [2] 310085 0
30/05/2014
Ethics approval number [2] 310085 0
E014/002

Summary
Brief summary
The proposed research aims to complete a comprehensive assessment of the physical health of Vietnam Veterans with and without posttraumatic stress disorder (PTSD) to improve the understanding of the illnesses associated with PTSD. Assessment of organ function in each group will be carried out to provide information regarding which conditions are associated with PTSD and how these relate and are inter-related. Mechanisms by which these proposed associations may be explained will be explored. This will include investigation of mechanisms which have been proposed as causing physical health damage in PTSD. These include dysregulation of the hypothalamic pituitary axis (HPA), chronic activation of the sympathetic nervous system and chronic inflammation. In addition, neurogenetic and epigenetic studies will be included to identify the genes and their genetic and epigenetic variants that contribute to the susceptibility to either PTSD or to physical damage associated with PTSD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46642 0
Prof Darrell Crawford
Address 46642 0
School of Medicine
The University of Queensland
Herston Road
Herston QLD 4029
Country 46642 0
Australia
Phone 46642 0
+61 7 3365 5316
Fax 46642 0
Email 46642 0
[email protected]
Contact person for public queries
Name 46643 0
Prof Darrel Crawford
Address 46643 0
School of Medicine, The University of Queensland, Herston Road, Herston, QLD, 4029
Country 46643 0
Australia
Phone 46643 0
+61 7 3365 5316
Fax 46643 0
Email 46643 0
[email protected]
Contact person for scientific queries
Name 46644 0
Prof Darrel Crawford
Address 46644 0
School of Medicine, The University of Queensland, Herston Road, Herston, QLD, 4029
Country 46644 0
Australia
Phone 46644 0
+61 7 3365 5316
Fax 46644 0
Email 46644 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
TBC


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Bruenig D, Lurie J, Morris CP, Harvey W, Lawford B... [More Details]
Study results articleYes McLeay SC, Harvey WM, Romaniuk MN, Crawford DH, Co... [More Details]
Study results articleYes Bruenig D, Mehta D, Morris CP, Harvey W, Lawford B... [More Details]
Study results articleYes Bruenig D, Mehta D, Morris CP, Lawford B, Harvey W... [More Details]
Study results articleYes Bruenig D, Morris CP, Mehta D, Harvey W, Lawford B... [More Details]
Study results articleYes Mehta D, Bruenig D, Carrillo-Roa T, Lawford B, Har... [More Details]
Study results articleYes Akosile W, Young R, Lawford B, Voisey J, Colquhoun... [More Details]
Study results articleYes Mehta, D., Bruenig, D., Lawford, B., Harvey, W., C... [More Details]
Study results articleYes Baird T, McLeay S, Harvey W, Theal R, Law D, O’Sul... [More Details]
Study results articleYes Theal R, Tay VXP, Hickman I. Conflicting relations... [More Details]
Study results articleYes Baird T, Theal R, Gleeson S, McLeay S, O’Sullivan ... [More Details]
Study results articleYes Mehta, D., Voisey, J., Bruenig, D., Harvey, W., Mo... [More Details]
Study results articleYes Akosile, W., Voisey, J., Lawford, B., Colquhounc, ... [More Details]
Study results articleYes Theal R., McLeay S., Gleeson S., Lowrie F., and R.... [More Details]
Study results articleYes DNA methylation from germline cells in veterans wi... [More Details]
Study results articleYes Differential BDNF methylation in combat exposed ve... [More Details]
Study results articleYes Gilmour J, & Romaniuk M. Factor structure of postt... [More Details]
Study results articleYes Theal, R., et al., Psychotropic polypharmacy in Au... [More Details]

Documents added automatically
No additional documents have been identified.