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Completed

NCT Number: NCT03915977

Patterns of PTSD in Adult Patients After Intensive Care

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Holbæk Hospital

Holbæk, Region Sjælland, 4300, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Post ICU recovery program

Behavioral

Standardized follow up program

Primary outcomes

  1. Post traumatic stress disorder (PTSD)

    Time frame: 12 months

    Harvard Trauma Questionnaire, Range 18-72

Secondary outcomes

  1. Anxiety

    Time frame: 12 months

    Hospital Anxiety and Depression Scale (HADS) covering anxiety (7 items) Range: 0-21

  2. Anxiety

    Time frame: 3 months

    Hospital Anxiety and Depression Scale (HADS) covering anxiety (7 items) Range: 0-21

  3. Depression

    Time frame: 12 months

    Hospital Anxiety and Depression Scale (HADS) covering Depression (7 items) Range: 0-21

  4. Depression

    Time frame: 3 months

    Hospital Anxiety and Depression Scale (HADS) covering depression (7 items) Range: 0-21

  5. PTSD

    Time frame: Baseline

    Harvard Trauma Questionnaire, Range 18-72

  6. PTSD

    Time frame: 3 months

    Harvard Trauma Questionnaire, Range 18-72

  7. PTSD

    Time frame: Over time at baseline, 3 and 12 months

    Change score using Harvard Trauma Questionnaire, Range 18-72

  8. Anxiety

    Time frame: Over time at 3 and 12 months

    Change score Using Hospital Anxiety and Depression Scale (HADS) covering anxiety (7 items) Range: 0-21

  9. Depression

    Time frame: Over time at 3 months and 12 months

    Change score using Hospital Anxiety and Depression Scale (HADS) covering depression (7 items) Range: 0-21

Sponsors and collaborators

Lead sponsor

Holbaek Sygehus

Other

Collaborators

  • Hillerod Hospital, Denmark

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 16, 2019
Registry last updated
Aug 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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