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

NCT00912613 | Completed DMC

• 1 other identifier: 06/Q1502/127
• Study Type: interventional
• Target: 352
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post-Traumatic Stress Disorder

Keywords

Critical illness; ICU Diaries; Post Traumatic Stress Disorder; Incidence

Outcome Measures

Primary Outcomes (1)

• Diagnosis of Post Traumatic Stress Disorder

  3 months post critical illness

Study Arms (2)

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

Other: ICU Diary

Interventions

ICU Diary OTHER

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

ICU Diary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients staying on the ICU for at least 72 hours (with greater than 24 hours of artificial ventilation)

You may not qualify if:

• ICU stay \< 72 hours
• Too confused for informed consent
• Pre-existing psychotic illness

Sponsors & Collaborators

• University of Liverpool: lead
• St Helens & Knowsley Teaching Hospitals NHS Trust: collaborator
• Vrinnevishuset, Sweden: collaborator
• Università degli Studi di Ferrara: collaborator
• University of Copenhagen: collaborator
• Haukeland University Hospital: collaborator
• Hospital Pedro Hispano: collaborator
• Sahlgrenska University Hospital: collaborator
• General Hospital of Santo António: collaborator

Related Publications (1)

• 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.

  PMID: 20843344 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Critical Illness

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard D Griffiths, MD

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 3, 2009
• Study Start: July 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 3, 2009

Record last verified: 2009-06