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

Not Applicable

• Conditions: Post-traumatic stress disorder; Cardiac arrest; Mental Health - Other mental health disorders; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12619001038189
• Lead Sponsor: The George Institute for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-22
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>[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).]