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

NCT ID: NCT00912613

Last Updated: 2009-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post-Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Discussion with nurse

Brief discussion with ICU follow-up nurse about the patients' critical illness

Group Type NO_INTERVENTION

No interventions assigned to this group

ICU Diary

Receipt of ICU Diary at 1 month post critical illness

Group Type EXPERIMENTAL

ICU Diary

Intervention Type OTHER

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

Interventions

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ICU Diary

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St Helens & Knowsley Teaching Hospitals NHS Trust

OTHER

Sponsor Role collaborator

Vrinnevishuset, Sweden

UNKNOWN

Sponsor Role collaborator

Università degli Studi di Ferrara

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role collaborator

Hospital Pedro Hispano

OTHER

Sponsor Role collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

General Hospital of Santo António

OTHER

Sponsor Role collaborator

University of Liverpool

OTHER

Sponsor Role lead

Responsible Party

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School of Clinical Science, University of Liverpool, Liverpool, UK

Principal Investigators

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Richard D Griffiths, MD

Role: PRINCIPAL_INVESTIGATOR

University of Liverpool

References

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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.

Reference Type DERIVED
PMID: 20843344 (View on PubMed)

Other Identifiers

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06/Q1502/127

Identifier Type: -

Identifier Source: org_study_id

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