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Patterns of PTSD in Adult Patients After Intensive Care

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ClinicalTrials.gov Identifier: NCT03915977
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
Hillerod Hospital, Denmark
Information provided by (Responsible Party):
Holbaek Sygehus

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

Condition or disease Intervention/treatment
Intensive Care Unit Syndrome Behavioral: Post ICU recovery program

Detailed 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 386 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Patterns of PTSD Over Time in Adult Intensive Care Patients - Observations From the RAPIT Trial
Actual Study Start Date : December 2, 2012
Actual Primary Completion Date : December 1, 2015
Actual Study Completion Date : December 1, 2015

Intervention Details:
  • Behavioral: Post ICU recovery program
    Standardized follow up program


Primary Outcome Measures :
  1. Post traumatic stress disorder (PTSD) [ Time Frame: 12 months ]
    Harvard Trauma Questionnaire, Range 18-72


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Intensive care patients (survivors)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915977


Locations
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Denmark
Holbæk Hospital
Holbæk, Sjælland, Denmark, 4300
Sponsors and Collaborators
Holbaek Sygehus
Hillerod Hospital, Denmark
Investigators
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Study Director: Janet F Jensen Holbaek Sygehus and Hillerod Hospital
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Holbaek Sygehus
ClinicalTrials.gov Identifier: NCT03915977    
Other Study ID Numbers: 18-000080
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: December 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No