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Completed

NCT Number: NCT00912613

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

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Key information

Conditions

Post-traumatic Stress Disorder Critical Illness Disease Attributes Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICU diary

Other

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

Primary outcomes

  1. Diagnosis of Post Traumatic Stress Disorder

    Time frame: 3 months post critical illness

Sponsors and collaborators

Lead sponsor

University of Liverpool

Other

Collaborators

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

Registry information

Official study title

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

Acronym: RACHEL II

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 3, 2009
Registry last updated
Jun 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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