Patterns of PTSD in Adult Patients After Intensive Care

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

Detailed Description
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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.

Official Title
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Patterns of PTSD Over Time in Adult Intensive Care Patients - Observations From the RAPIT Trial

Conditions
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Intensive Care Unit Syndrome

Intervention / Treatment
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* Behavioral: Post ICU recovery program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Non-invasive or invasive ventilation ≥ 48 hours ( Non-ivasive ventilation (NIV) from current guidelines) Undiagnosed dementia Exclusion Criteria: Delirium at randomization (positive CAM-ICU score) Participations in scientific projects which include patient interviews Not speaking or understanding danish.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Post ICU recovery program|Standardized follow up program|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post traumatic stress disorder (PTSD) | Harvard Trauma Questionnaire, Range 18-72 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Hospital Anxiety and Depression Scale (HADS) covering anxiety (7 items) Range: 0-21 | 12 months | 
| Anxiety | Hospital Anxiety and Depression Scale (HADS) covering anxiety (7 items) Range: 0-21 | 3 months | 
| Depression | Hospital Anxiety and Depression Scale (HADS) covering Depression (7 items) Range: 0-21 | 12 months | 
| Depression | Hospital Anxiety and Depression Scale (HADS) covering depression (7 items) Range: 0-21 | 3 months | 
| PTSD | Harvard Trauma Questionnaire, Range 18-72 | Baseline | 
| PTSD | Harvard Trauma Questionnaire, Range 18-72 | 3 months | 
| PTSD | Change score using Harvard Trauma Questionnaire, Range 18-72 | Over time at baseline, 3 and 12 months | 
| Anxiety | Change score Using Hospital Anxiety and Depression Scale (HADS) covering anxiety (7 items) Range: 0-21 | Over time at 3 and 12 months | 
| Depression | Change score using Hospital Anxiety and Depression Scale (HADS) covering depression (7 items) Range: 0-21 | Over time at 3 months and 12 months |