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

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.

Study Overview

• Status: Completed
• Conditions: Post-Traumatic Stress Disorder
• Intervention / Treatment: Other: ICU Diary

• Study Type: Interventional
• Enrollment (Actual): 352
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnosis of Post Traumatic Stress Disorder	3 months post critical illness

Collaborators and Investigators

• Sponsor: University of Liverpool
• Collaborators: University of Copenhagen; Università degli Studi di Ferrara; Sahlgrenska University Hospital, Sweden; Haukeland University Hospital; Hospital Pedro Hispano; St Helens & Knowsley Teaching Hospitals NHS Trust; General Hospital of Santo António; Vrinnevishuset, Sweden
• Investigators: Principal Investigator: Richard D Griffiths, MD, University of Liverpool

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: June 1, 2009
• First Submitted That Met QC Criteria: June 1, 2009
• First Posted (Estimate): June 3, 2009

Study Record Updates

• Last Update Posted (Estimate): June 3, 2009
• Last Update Submitted That Met QC Criteria: June 1, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: Critical illness; Incidence; Post Traumatic Stress Disorder; ICU Diaries
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease Attributes; Trauma and Stressor Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Critical Illness
• Other Study ID Numbers: 06/Q1502/127