Back to resultsIntensive Care Unit (ICU) Diaries as a Therapeutic Intervention for Post Traumatic Stress Disorder (PTSD) Following Critical Illness (RACHEL II)
Primary Purpose
Post-Traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ICU Diary
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring Critical illness, ICU Diaries, Post Traumatic Stress Disorder, Incidence
Eligibility Criteria
Inclusion Criteria:
- Patients staying on the ICU for at least 72 hours (with greater than 24 hours of artificial ventilation)
Exclusion Criteria:
- ICU stay < 72 hours
- Too confused for informed consent
- Pre-existing psychotic illness
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Discussion with nurse
ICU Diary
Arm Description
Brief discussion with ICU follow-up nurse about the patients' critical illness
Receipt of ICU Diary at 1 month post critical illness
Outcomes
Primary Outcome Measures
Diagnosis of Post Traumatic Stress Disorder
Secondary Outcome Measures
Full Information
NCT ID
NCT00912613
First Posted
June 1, 2009
Last Updated
June 1, 2009
Sponsor
University of Liverpool
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, Sweden, General Hospital of Santo António
1. Study Identification
Unique Protocol Identification Number
NCT00912613
Brief Title
Intensive Care Unit (ICU) Diaries as a Therapeutic Intervention for Post Traumatic Stress Disorder (PTSD) Following Critical Illness
Acronym
RACHEL II
Official Title
ICU Diaries as a Therapeutic Intervention for Post Traumatic Stress Disorder Following Critical Illness
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Liverpool
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, Sweden, General Hospital of Santo António
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
Critical illness, ICU Diaries, Post Traumatic Stress Disorder, Incidence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
352 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Discussion with nurse
Arm Type
No Intervention
Arm Description
Brief discussion with ICU follow-up nurse about the patients' critical illness
Arm Title
ICU Diary
Arm Type
Experimental
Arm Description
Receipt of ICU Diary at 1 month post critical illness
Intervention Type
Other
Intervention Name(s)
ICU Diary
Intervention Description
ICU Diary containing daily information of patients condition and treatment with appropriate photographs
Primary Outcome Measure Information:
Title
Diagnosis of Post Traumatic Stress Disorder
Time Frame
3 months post critical illness
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients staying on the ICU for at least 72 hours (with greater than 24 hours of artificial ventilation)
Exclusion Criteria:
ICU stay < 72 hours
Too confused for informed consent
Pre-existing psychotic illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard D Griffiths, MD
Organizational Affiliation
University of Liverpool
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
20843344
Citation
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.
Results Reference
derived
Learn more about this trial
Intensive Care Unit (ICU) Diaries as a Therapeutic Intervention for Post Traumatic Stress Disorder (PTSD) Following Critical Illness
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