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Trial registered on ANZCTR


Registration number
ACTRN12619001038189
Ethics application status
Approved
Date submitted
17/06/2019
Date registered
22/07/2019
Date last updated
22/07/2019
Date data sharing statement initially provided
22/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title

Post-Traumatic Stress Disorder (PTSD) in Survivors of Cardiac Arrest and in their Primary Caregiver: Sub-study of the TTM2 Trial
Scientific title


Post-Traumatic Stress Disorder (PTSD) in Survivors of Cardiac Arrest and in their Primary Caregiver. Assessment of PTSD symptoms will be undertaken using the Post-Traumatic Stress Disorder Checklist-Five (PCL-5).
Secondary ID [1] 298488 0
none
Universal Trial Number (UTN)
Trial acronym


TTM2: PTSD Sub-study
Linked study record
NCT02908308

The TTM2 PTSD Sub-study is registered under TTM2 Trial. However, the sub-study primary and secondary objectives are not addressed by the parent study. The stand-alone protocol for the sub-study addresses the sub-study specific management oversight, research question, objectives, operational requirements, specific ethical considerations, and data management.

Health condition
Health condition(s) or problem(s) studied:
Post-traumatic stress disorder 313140 0
Cardiac arrest 313459 0
Condition category
Condition code
Mental Health 311616 311616 0 0
Other mental health disorders
Cardiovascular 311890 311890 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The TTM2 trial is a phase III, multi-centre, randomised control clinical trial in resuscitated cardiac arrest patients admitted to the intensive care unit to investigate whether targeted temperature management to 33 degrees improves survival and neurological outcome at 6-months compared to a strategy of targeting normothermia and avoiding fever above 37.7 degrees.
All participants that have been included in the TTM2 trial in participating cities of the PTSD sub-study (Bristol in United Kingdom, Lund in Sweden, Brisbane, Melbourne and Sydney in Australia) are invited to attend a follow-up clinic at 6 and 24-months. At these follow-up visits, trained, blinded assessors will perform structured interviews and will administer tests to the participant focusing on cognitive function, quality of life, return to work and cardiovascular risk factors. At the end of the scheduled follow-up visits, the participant and the primary relative/friend/caregiver will be asked to participate in the PTSD sub-study which they will be required to complete a self-reported Post-Traumatic Stress Disorder Checklist (PCL-5), which is a 20-item screening tool for assessment of PTSD. The PCL-5 takes 5-10 minutes to complete.
Intervention code [1] 314884 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320315 0
Outcome- Proportion of participants and primary caregivers meeting the mild, moderate, severe and extreme Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) categories for PTSD symptoms.
Timepoint [1] 320315 0
All participants that have been included in the TTM2 trial are invited to attend a follow-up clinic at 6 and 24-months after their OOHC. At the end of the scheduled 6 and 24-month follow-up visits for the parent study, the participant and the primary relative/friend/caregiver will be asked to participate in the PTSD sub-study which they will be required to complete a self-reported Post-Traumatic Stress Disorder Checklist (PCL-5).
Secondary outcome [1] 371219 0

Secondary and exploratory objectives include:
Differences in PTSD rates in primary caregivers who performed, witnessed, or visited the patient in ICU.
At the 6-month scheduled follow-up visit the outcome assessor will screen the primary care giver using the study inclusion criteria and if the primary care giver meets all inclusion criteria and agrees to participation then the outcome assessor will ask the primary care giver to complete the PCL-5 (self-reported 20 item ) checklist.
.
Timepoint [1] 371219 0
6 and 24-months
Secondary outcome [2] 372209 0
Differences in PTSD rates in participants whom had witnessed versus unwitnessed cardiac arrest. PTSD will be asssessed using the PCL-5 self reported by participants.
The PCL-5 will be completed at the scheduled follow-up visits.
Timepoint [2] 372209 0
6 and 24 months
Secondary outcome [3] 372210 0
Exploratory analysis of pre-Arrest function, prior cardiac history or cardiac arrest on PTSD rates in participants using data already captured on the data collection form from the parent study.
Timepoint [3] 372210 0
6 and 24 months
Secondary outcome [4] 372211 0
Exploratory analyses of GOSE score (high vs low) and PTSD rates
Timepoint [4] 372211 0
6 and 24 months
Secondary outcome [5] 372212 0
Associations between EQ-5D-5L anxiety and depression scores and PTSD rates
Timepoint [5] 372212 0
6 and 24 months

Eligibility
Key inclusion criteria
All participants that have been included in the TTM2 study who attend the 6-months follow-up for the main study are eligible for inclusion in the PTSD study.
The primary carer of the participant is also eligible if they meet the following criteria:
1. Witnessed the cardiac arrest OR visited the participant at least once in the ICU
2. AND Lives with the participant OR whom has weekly (or more frequent contact (in person or over the telephone) with the participant
3. AND attends the 6-month visit with the participant

Currently Australia, Sweden and UK have ethical approval to conduct this sub-study. Other countries that are participating in the parent study are invited to participate in the PTSD sub-study however this is dependent on resources.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who do not wish or decline consent to be followed-up as part of the TTM2 trial.
Primary caregiver who does not consent to be part of the follow-up process or who are not in close contact with the TTM2 trial participant as the inclusion criteria specifies.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Descriptive statistics (Number/Proportions) of patients meeting mild (0-20), moderate (20-40), severe (40-60), extreme (60-80) cutoffs will be reported.
Baseline characteristics of the participants will be reported. Comparison over time from 6-months to 24-months will be conducted. Comparisons between witnessing cardiac arrest or performing life support compared with not witnessing or performing CPR will be conducted for the primary caregiver.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 13927 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 13928 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 13929 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [4] 13930 0
Concord Repatriation Hospital - Concord
Recruitment hospital [5] 13931 0
St George Hospital - Kogarah
Recruitment hospital [6] 13932 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 13933 0
The Alfred - Prahran
Recruitment hospital [8] 13934 0
The Northern Hospital - Epping
Recruitment hospital [9] 13935 0
John Hunter Hospital - New Lambton
Recruitment hospital [10] 13936 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [11] 13937 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 26699 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 26697 0
2065 - St Leonards
Recruitment postcode(s) [3] 26700 0
2139 - Concord
Recruitment postcode(s) [4] 26698 0
2170 - Liverpool
Recruitment postcode(s) [5] 26701 0
2217 - Kogarah
Recruitment postcode(s) [6] 26705 0
2305 - New Lambton
Recruitment postcode(s) [7] 26707 0
2747 - Kingswood
Recruitment postcode(s) [8] 26703 0
3004 - Prahran
Recruitment postcode(s) [9] 26704 0
3076 - Epping
Recruitment postcode(s) [10] 26706 0
3084 - Heidelberg
Recruitment postcode(s) [11] 26702 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 21575 0
Sweden
State/province [1] 21575 0
Lund
Country [2] 21601 0
United Kingdom
State/province [2] 21601 0
Bristsol

Funding & Sponsors
Funding source category [1] 302966 0
Other
Name [1] 302966 0
The George Institute for Global Health
Address [1] 302966 0
1 King Street Newtown, NSW, 2042, Australia
Country [1] 302966 0
Australia
Primary sponsor type
Other
Name
The George Institute for Global Health
Address
1 King Street Newtown, NSW, 2042, Australia
Country
Australia
Secondary sponsor category [1] 303205 0
None
Name [1] 303205 0
None
Address [1] 303205 0
None
Country [1] 303205 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303520 0
'Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 303520 0
Camperdown, NSW, 2050
Ethics committee country [1] 303520 0
Australia
Date submitted for ethics approval [1] 303520 0
07/08/2018
Approval date [1] 303520 0
17/08/2018
Ethics approval number [1] 303520 0

Summary
Brief summary
Study Synopsis
Background: Post-Traumatic Stress Disorder (PTSD) is a mental illness that develops in some individuals following a traumatic event. PTSD can cause significant distress, poor function and detrimental health outcomes for patients as well as their primary relative/friend or carer and has been estimated to be prevalent in more than a third of both patients and relatives, though reported prevalence is highly variable.
Objective: Quantify the burden of PTSD in survivors of out-of-hospital cardiac arrest (OHCA) and in their primary caregiver at 6 and 24-months and determine changes over time in PTSD rates.
Method: This is a sub-study of the TTM2 Trial. All participants that have been included in the TTM2 trial who attend the 6-months follow-up for the main study are eligible for inclusion in the PTSD study. The primary carer of the participant is also eligible if they meet the following criteria: Witnessed the cardiac arrest OR visited the participant at least once in the ICU AND lives with the participant OR whom has weekly or more frequent contact (in person or over the telephone) with the participant AND attends the 6-months visit with the participant.
The participant and their primary caregiver will be asked to complete a self-administered 20-item questionnaire (Post-traumatic stress CheckList-5 (PCL-5)).
Outcome: Proportion of participants and primary caregivers meeting the mild, moderate, severe and extreme Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) categories for PTSD symptoms. Changes over time of PTSD rates at 6-months vs 24-months will also be reported.
Trial website
Parent study website- ttm2trial.org
Trial related presentations / publications
See website
Public notes
Nil

Contacts
Principal investigator
Name 93950 0
Dr Naomi Hammond
Address 93950 0
Senior Research Fellow and Operational Lead, Division of Critical Care
The George Institute for Global Health
1 King Street, Newtown, NSW, 2042
Country 93950 0
Australia
Phone 93950 0
+61 (0) 2 8052 4352
Fax 93950 0
Email 93950 0
nhammond@georgeinstitute.org.au
Contact person for public queries
Name 93951 0
Dr Naomi Hammond
Address 93951 0
Senior Research Fellow and Operational Lead, Division of Critical Care
The George Institute for Global Health
1 King Street, Newtown, NSW, 2042
Country 93951 0
Australia
Phone 93951 0
+61 (0) 2 8052 4352
Fax 93951 0
Email 93951 0
nhammond@georgeinstitute.org.au
Contact person for scientific queries
Name 93952 0
Dr Naomi Hammond
Address 93952 0
Senior Research Fellow and Operational Lead, Division of Critical Care
The George Institute for Global Health
1 King Street, Newtown, NSW, 2042
Country 93952 0
Australia
Phone 93952 0
+61 (0) 2 8052 4352
Fax 93952 0
Email 93952 0
nhammond@georgeinstitute.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The sub-study database sharing will be governed by the approving ethics committee. The main study data sharing policies and those outlined by The George Institute for Global Health.
What supporting documents are/will be available?
No other documents available
Summary results
No Results