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Intensive Care Unit (ICU) Diaries as a Therapeutic Intervention for Post Traumatic Stress Disorder (PTSD) Following Critical Illness (RACHEL II)

This study has been completed.
Sponsor:
Collaborators:
St Helens & Knowsley Teaching Hospitals NHS Trust
Vrinnevishuset, Sweden
Università degli Studi di Ferrara
University of Copenhagen
Haukeland University Hospital
Hospital Pedro Hispano, Portugal
Sahlgrenska University Hospital, Sweden
Geral de Sabto Hospital, Portugal
Information provided by:
University of Liverpool
ClinicalTrials.gov Identifier:
NCT00912613
First received: June 1, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Post-Traumatic Stress Disorder
 Other: ICU Diary

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ICU Diaries as a Therapeutic Intervention for Post Traumatic Stress Disorder Following Critical Illness

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Liverpool:

Primary Outcome Measures:
  • Diagnosis of Post Traumatic Stress Disorder [ Time Frame: 3 months post critical illness ] [ Designated as safety issue: No ]

Enrollment: 352
Study Start Date: July 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Discussion with nurse
Brief discussion with ICU follow-up nurse about the patients' critical illness
Experimental: ICU Diary
Receipt of ICU Diary at 1 month post critical illness
 Other: ICU Diary
ICU Diary containing daily information of patients condition and treatment with appropriate photographs

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912613

Sponsors and Collaborators
University of Liverpool
St Helens & Knowsley Teaching Hospitals NHS Trust
Vrinnevishuset, Sweden
Università degli Studi di Ferrara
University of Copenhagen
Haukeland University Hospital
Hospital Pedro Hispano, Portugal
Sahlgrenska University Hospital, Sweden
Geral de Sabto Hospital, Portugal
Investigators
Principal Investigator: Richard D Griffiths, MD University of Liverpool
  More Information

No publications provided by University of Liverpool

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Professor Richard David Griffiths, School of Clinical Science, University of Liverpool, Liverpool, UK
ClinicalTrials.gov Identifier: NCT00912613     History of Changes
Other Study ID Numbers: 06/Q1502/127
Study First Received: June 1, 2009
Last Updated: June 1, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Liverpool:
Critical illness
ICU Diaries
Post Traumatic Stress Disorder
Incidence

Additional relevant MeSH terms:
Critical Illness
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Disease Attributes
 Pathologic Processes
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013