Patterns of PTSD in Adult Patients After Intensive Care

Status Completed

Clinical Trial Summary

This study aims to describe adult patients' patterns of Post-traumatic stress disorder (PTSD) at discharge, 3, and 12 months after intensive care.

Clinical Trial Description

The present study is a secondary analysis of the RAPIT-trial study treating data from patients on Post-traumatic stress disorder (PTDS) (Jensen et al., 2016).

Design Observational study based on data from the RAPIT trial that is a non-blinded, multicentre, parallel-group RCT conducted between December 2012-2015, at 10 intensive care units (ICUs) in four out of five regions in Denmark.

Participants Patients were consecutively recruited during the first 18 months of the study. We included Danish-speaking adults (≥18 years) who received mechanically ventilated ≥48 hours and did not meet the baseline criteria of dementia. We excluded delirious patients unable to give informed consent at randomization, or patients, who were enrolled in other studies. A total of 386 adult patients were randomized to standard care (SC) plus a nurse-led intensive care recovery program or standard care alone after ICU discharge (190 intervention, 196 SC).

Outcomes In this study, we will describe variations in patients, who experience symptoms of PTSD at ICU-discharge, 3 and 12 months after intensive care based on the data collection in the RAPIT-trial (Jensen et al., 2016). We will report trial participants' symptoms of PTSD at baseline, three months and twelve months after Intensive care using the Harvard Trauma Questionnaire (HTQ) supplemented with descriptions of patients' experiences of PTSD. Symptoms of anxiety and depression were collected at 3 and 12 months, and utilization of healthcare services including mortality were obtained from hospital charts combined with self-reported data from patients. We will use descriptive statistical methods to analyze data.

Symptoms of PTSD by HTQ-IV consisted of 17 items covering three core symptoms corresponding to DSM-IV criteria for PTSD: re-experience (5 items), avoidance (7 items), and arousal (5 items). This was supplemented by four additional items: one functional and three related to stress. We used a total score, and a cut-off of ≥40 is categorized as "positive PTSD". Symptoms of anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS) covering two dimensions: anxiety (7 items) and depression (7 items); subscale scores were 0-21 with higher scores reflecting greater psychological distress. ;

Study Design

Related Conditions & MeSH terms

Intensive Care Unit Syndrome

Clinical Trial Details

NCT number	NCT03915977
Study type	Observational [Patient Registry]
Source	Holbaek Sygehus
Contact
Status	Completed
Phase
Start date	December 2, 2012
Completion date	December 1, 2015

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.