Post-Traumatic Stress DisorderRACHEL IINCT00912613
Intensive Care Unit (ICU) Diaries as a Therapeutic Intervention for Post Traumatic Stress Disorder (PTSD) Following Critical Illness
A study testing ICU Diary in people with Post-Traumatic Stress Disorder, run by University of Liverpool.
Trial summary
The incidence of PTSD post ICU varies from unit to unit, however a significant number of patients have been shown to develop this disorder. Many patients do not recall their stay in ICU properly and yet can clearly recall nightmares, hallucinations or paranoid delusions, which may be very frightening for the patient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- ICU Diary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Dec 2008
- Phase
- Interventional
- 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
Who may be able to join
- Patients staying on the ICU for at least 72 hours (with greater than 24 hours of artificial ventilation)
Who cannot join
- ICU stay < 72 hours
- Too confused for informed consent
- Pre-existing psychotic illness
About this study
Official title: ICU Diaries as a Therapeutic Intervention for Post Traumatic Stress Disorder Following Critical Illness
The incidence of PTSD post ICU varies from unit to unit, however a significant number of patients have been shown to develop this disorder. Many patients do not recall their stay in ICU properly and yet can clearly recall nightmares, hallucinations or paranoid delusions, which may be very frightening for the patient to recall at a later stage. As yet, no interventional studies have had an impact on the development of PTSD in this population of patients. However, a recent observational multi-centre study suggested that those patients receiving a diary of their time in ICU had lower levels of symptoms of PTSD than those who did not. These results need to be verified in the form of a randomized study.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- ICU Diary
- Keywords
- Critical illness, ICU Diaries, Post Traumatic Stress Disorder, Incidence
- Medical subject headings
- Stress Disorders, Post-Traumatic, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU DiaryOther
ICU Diary containing daily information of patients condition and treatment with appropriate photographs
| Study group | Role | What they receive |
|---|---|---|
| Discussion with nurse | No intervention | Brief discussion with ICU follow-up nurse about the patients' critical illness |
| ICU Diary | Experimental | Receipt of ICU Diary at 1 month post critical illness Receives: Other: ICU Diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of Post Traumatic Stress Disorder
Measured: 3 months post critical illness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startJul 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- St Helens & Knowsley Teaching Hospitals NHS Trust, Vrinnevishuset, Sweden, Università degli Studi di Ferrara, University of Copenhagen, Haukeland University Hospital, Hospital Pedro Hispano, Sahlgrenska University Hospital, General Hospital of Santo António
- Investigators
- Richard D Griffiths, MD, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912613
- Sponsor's protocol ID
- 06/Q1502/127
- Acronym
- RACHEL II
- Status last verified
- Jun 2009
- First submitted
- 1 Jun 2009
- Last updated
- 3 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jones C, Backman C, Capuzzo M, Egerod I, Flaatten H, Granja C, Rylander C, Griffiths RD; RACHEL group. Intensive care diaries reduce new onset post traumatic stress disorder following critical illness: a randomised, controlled trial. Crit Care. 2010;14(5):R168. doi: 10.1186/cc9260. Epub 2010 Sep 15.
PubMed 20843344
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICU Diaries as a Therapeutic Intervention for Post Traumatic Stress Disorder Following Critical Illness
- ClinicalTrials.gov ID
- NCT00912613
- Acronym / sponsor ID
- RACHEL II / 06/Q1502/127
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Critical illness, ICU Diaries, Post Traumatic Stress Disorder, Incidence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- St Helens & Knowsley Teaching Hospitals NHS Trust, Vrinnevishuset, Sweden, Università degli Studi di Ferrara, University of Copenhagen, Haukeland University Hospital, Hospital Pedro Hispano, Sahlgrenska University Hospital, General Hospital of Santo António
- Study start
- Jul 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 3 Jun 2009 (estimated)
- 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.
The incidence of PTSD post ICU varies from unit to unit, however a significant number of patients have been shown to develop this disorder. Many patients do not recall their stay in ICU properly and yet can clearly recall nightmares, hallucinations or paranoid delusions, which may be very frightening for the patient to recall at a later stage. As yet, no interventional studies have had an impact on the development of PTSD in this population of patients. However, a recent observational multi-centre study suggested that those patients receiving a diary of their time in ICU had lower levels of symptoms of PTSD than those who did not. These results need to be verified in the form of a randomized study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Discussion with nurse | No intervention | –Brief discussion with ICU follow-up nurse about the patients' critical illness |
| ICU Diary | Experimental | Other: ICU DiaryReceipt of ICU Diary at 1 month post critical illness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients staying on the ICU for at least 72 hours (with greater than 24 hours of artificial ventilation)
Key exclusion criteria (3 listed)
- ICU stay < 72 hours
- Too confused for informed consent
- Pre-existing psychotic illness
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 |
|---|---|---|
| ICU DiaryICU Diary containing daily information of patients condition and treatment with appropriate photographs | Other | ICU Diary |
Primary outcome
Diagnosis of Post Traumatic Stress Disorder
Time frame: 3 months post critical illness
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 3 Jun 2009.
- Derived from this study: PubMed 20843344Jones C, Backman C, Capuzzo M, Egerod I, Flaatten H, Granja C, Rylander C, Griffiths RD; RACHEL group. Intensive care diaries reduce new onset post traumatic stress disorder following critical illness: a randomised, controlled trial. Crit Care. 2010;14(5):R168. doi: 10.1186/cc9260. Epub 2010 Sep 15.
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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.
Richard D Griffiths, MD principal investigator
University of Liverpool
Questions about this trial
What is this clinical trial studying?
A study testing ICU Diary in people with Post-Traumatic Stress Disorder, run by University of Liverpool.
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 1 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 3 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Diagnosis of Post Traumatic Stress Disorder (time frame: 3 months post critical illness). 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 NCT00912613, which also lists 1 linked publication.
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 3 Jun 2009.