None listed
Conditions
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.
Interventions
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,
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.
Sponsors
The George Institute for Global Health
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed