Intensive Care Unit SyndromeNCT03915977
Patterns of PTSD in Adult Patients After Intensive Care
An observational study of Intensive Care Unit Syndrome, run by Holbaek Sygehus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Syndrome
- What is being tested?
- Post ICU recovery program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 386 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Dec 2012to 1 Dec 2015
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intensive care patients (survivors)
Who may be able to join
- Age ≥ 18 years
- Non-invasive or invasive ventilation ≥ 48 hours ( Non-ivasive ventilation (NIV) from current guidelines)
- Undiagnosed dementia
Who cannot join
- Delirium at randomization (positive CAM-ICU score)
- Participations in scientific projects which include patient interviews
- Not speaking or understanding danish.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patterns of PTSD Over Time in Adult Intensive Care Patients - Observations From the RAPIT Trial
This study aims to describe adult patients' patterns of Post-traumatic stress disorder (PTSD) at discharge, 3, and 12 months after intensive care.
Read the 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.
- Conditions
- Intensive Care Unit Syndrome
- Being tested
- Post ICU recovery program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post ICU recovery programBehavioural
Standardized follow up program
What is being measured
The primary outcome is the main question the study is designed to answer.
Post traumatic stress disorder (PTSD)
Harvard Trauma Questionnaire, Range 18-72
Measured: 12 months
Secondary outcomes (9)
Anxiety
Hospital Anxiety and Depression Scale (HADS) covering anxiety (7 items) Range: 0-21
Measured: 12 months
Anxiety
Hospital Anxiety and Depression Scale (HADS) covering anxiety (7 items) Range: 0-21
Measured: 3 months
Depression
Hospital Anxiety and Depression Scale (HADS) covering Depression (7 items) Range: 0-21
Measured: 12 months
Depression
Hospital Anxiety and Depression Scale (HADS) covering depression (7 items) Range: 0-21
Measured: 3 months
PTSD
Harvard Trauma Questionnaire, Range 18-72
Measured: Baseline
PTSD
Harvard Trauma Questionnaire, Range 18-72
Measured: 3 months
PTSD
Change score using Harvard Trauma Questionnaire, Range 18-72
Measured: 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
Measured: Over time at 3 and 12 months
Depression
Change score using Hospital Anxiety and Depression Scale (HADS) covering depression (7 items) Range: 0-21
Measured: Over time at 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start2 Dec 2012
- Primary completion1 Dec 2015
- Study completion1 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 386 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Holbaek Sygehus
- Sponsor type
- University, hospital or other
- Collaborators
- Hillerod Hospital, Denmark
- Responsible party
- Sponsor
- Investigators
- Janet F Jensen, Study director, Holbaek Sygehus and Hillerod Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915977
- Sponsor's protocol ID
- 18-000080
- Status last verified
- Dec 2012
- First submitted
- 12 Apr 2019
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jensen JF, Overgaard D, Bestle MH, Christensen DF, Rattray J, Egerod I. Intervention fidelity in postintensive care follow-up consultations at ten sites in the RAPIT-trial: A mixed-methods evaluation. J Adv Nurs. 2019 Apr;75(4):862-875. doi: 10.1111/jan.13949. Epub 2019 Feb 12.
PubMed 30644124Jensen JF, Egerod I, Bestle MH, Christensen DF, Elklit A, Hansen RL, Knudsen H, Grode LB, Overgaard D. A recovery program to improve quality of life, sense of coherence and psychological health in ICU survivors: a multicenter randomized controlled trial, the RAPIT study. Intensive Care Med. 2016 Nov;42(11):1733-1743. doi: 10.1007/s00134-016-4522-1. Epub 2016 Sep 30.
PubMed 27695894
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of PTSD Over Time in Adult Intensive Care Patients - Observations From the RAPIT Trial
- ClinicalTrials.gov ID
- NCT03915977
- Acronym / sponsor ID
- 18-000080
- Conditions
- Intensive Care Unit Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Holbaek SygehusUniversity, hospital or other
- Collaborators
- Hillerod Hospital, Denmark
- Study start
- 2 Dec 2012 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 1 Dec 2015 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care patients (survivors)
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Non-invasive or invasive ventilation ≥ 48 hours ( Non-ivasive ventilation (NIV) from current guidelines)
- Undiagnosed dementia
Key exclusion criteria (3 listed)
- Delirium at randomization (positive CAM-ICU score)
- Participations in scientific projects which include patient interviews
- Not speaking or understanding danish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post ICU recovery programStandardized follow up program | Behavioural | – |
Primary outcome
Post traumatic stress disorder (PTSD)
Time frame: 12 months
Harvard Trauma Questionnaire, Range 18-72
9 secondary outcomes
Anxiety
Time frame: 12 months
Anxiety
Time frame: 3 months
Depression
Time frame: 12 months
Depression
Time frame: 3 months
PTSD
Time frame: Baseline
PTSD
Time frame: 3 months
PTSD
Time frame: Over time at baseline, 3 and 12 months
Anxiety
Time frame: Over time at 3 and 12 months
Depression
Time frame: Over time at 3 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Background: PubMed 30644124Jensen JF, Overgaard D, Bestle MH, Christensen DF, Rattray J, Egerod I. Intervention fidelity in postintensive care follow-up consultations at ten sites in the RAPIT-trial: A mixed-methods evaluation. J Adv Nurs. 2019 Apr;75(4):862-875. doi: 10.1111/jan.13949. Epub 2019 Feb 12.
- Results publication: PubMed 27695894Jensen JF, Egerod I, Bestle MH, Christensen DF, Elklit A, Hansen RL, Knudsen H, Grode LB, Overgaard D. A recovery program to improve quality of life, sense of coherence and psychological health in ICU survivors: a multicenter randomized controlled trial, the RAPIT study. Intensive Care Med. 2016 Nov;42(11):1733-1743. doi: 10.1007/s00134-016-4522-1. Epub 2016 Sep 30.
- Homepage for project collaboratorsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet F Jensen study director
Holbaek Sygehus and Hillerod Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit Syndrome, run by Holbaek Sygehus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post traumatic stress disorder (PTSD) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03915977, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019; AzTrials last refreshed its copy on 8 Nov 2026.