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

Post-Traumatic Stress Disorder Clinical Trial

— RACHEL II  

Official title:

ICU Diaries as a Therapeutic Intervention for Post Traumatic Stress Disorder Following Critical Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00912613
• Other study ID #: 06/Q1502/127
• Status: Completed
• Phase: N/A
• First received: June 1, 2009
• Last updated: June 1, 2009
• Start date: July 2007
• Est. completion date: December 2008

Study information

• Verified date: June 2009
• Source: University of Liverpool
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• ICU Diary
ICU Diary containing daily information of patients condition and treatment with appropriate photographs

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
University of Liverpool	Geral de Sabto Hospital, Portugal, Haukeland University Hospital, Hospital Pedro Hispano, Sahlgrenska University Hospital, Sweden, St Helens & Knowsley Teaching Hospitals NHS Trust, Università degli Studi di Ferrara, University of Copenhagen, Vrinnevishuset, Sweden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of Post Traumatic Stress Disorder		3 months post critical illness	No