Psychological Stress in intensive care survivors

Not Applicable

Completed

• Conditions: Post Traumatic Stress Disorder (PTSD); Anxiety; Depression; Mental Health - Other mental health disorders; Mental Health - Anxiety; Mental Health - Depression

• Registration Number: ACTRN12615000880549
• Lead Sponsor: Sumeet Rai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-24
• Study Completion: 2019-07-31
• Last Update Posted: 16 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 327

Inclusion Criteria

A) Intubated ICU survivor:
* Age 18 years and older
* Able to consent
* Intubated and mechanically ventilated for more than 24 hours AND ICU stay for more than 72 hours

B) Non intubated ICU survivor:

* Age 18 years and older
* Able to consent
* Not been intubated during current ICU stay
* Received inotropic/vasopressor support and/or non invasive ventilation during ICU stay
* ICU stay for less than 72 hours

Family Members
* Family member (spouse/partner/next of kin/lives with patient normally) of patients with above criteria
* Age 18 years and older

Exclusion Criteria

Common criteria
* Background psychiatric history (schizo affective disorders, chronic PTSD)
* Non English Speaking Background (screening tests are validated in English)
* Imminent death/palliative care patient (exclusion as a result of unlikely follow up at 2 months)

ICU patient survivors (additional criteria)
* Suspected acute primary brain lesion that may result in global impairment of conscious level or cognition, such as traumatic brain injury, intracranial haemorrhage, stroke, or hypoxic brain injury.
* Unable to give informed consent prior to hospital discharge.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of PTSD in ICU survivors[At 3 and 12 months using Post Traumatic Stress Scale (PTSS 14) and Revised Impact of Event Scale (IES-R)];Incidence of Depression and Anxiety in ICU survivors[At 3 and 12 months using a 21 point Depression Anxiety Stress Scale (DASS 21)];Incidence of PTSD in family members of ICU survivors[At 3 and 12 months using revised Impact of Event Sale (IES-R)]

Secondary Outcome Measures

Name	Time	Method
Association between presence of delirium in ICU and psychological outcomes of ICU survivors [Reviewing patient records for incidence of delirium using either a positive Confusion Assessment Method for ICU (CAM-ICU) and/or newer antipsychotic use during ICU admission and comparing with the PTSS-14 and DASS-21 scores at 3 and 12 months];Composite outcome: Severity of illness of patient and effect on psychological stress in ICU survivors and their family members[Reviewing patient data for Admission diagnosis, APACHE III scores, length of ventilation, etc AND comparing with extent of psychological stress in survivors and family members at 3 and 12 months using above mentioned tools like PTSS-14, DASS21, IES-R];Primary outcome 4: Incidence of Depression and Anxiety in family members of ICU survivors[At 3 and 12 months using DASS -21 tool]