Condition category
Mental and Behavioural Disorders
Date applied
21/05/2010
Date assigned
21/05/2010
Last edited
27/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jacobus Preller

ORCID ID

Contact details

Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
jacobus.preller@addenbrookes.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7987

Study information

Scientific title

A randomised controlled pilot study of the effectiveness of recreating a coherent narrative of events using novel developments in cognitive and behaviour therapy for the treatment of post-traumatic stress disorder in survivors of intensive care treatment

Acronym

Study hypothesis

A single-centre randomised single-blind controlled pilot study evaluating the efficacy of a brief psychological intervention for the treatment of intensive care unit (ICU) survivors with post-traumatic stress disorder (PTSD), based on novel developments in cognitive behavioural therapy (CBT) and narrative exposure therapy (NET). The study will create and implement a psychotherapeutic intervention to address the problem of fragmented and delusional memories, by creating a coherent narrative of events, which would allow the ICU survivor to process their ICU experience. The different components of the intervention proposed have been validated as an effective intervention in studies on PTSD (CBT).

Ethics approval

Essex 2 Research Ethics Committee, 05/07/2007, ref: 07/Q0302/20

Study design

Single-centre observational treatment case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please contact jacobus.preller@addenbrookes.nhs.uk to request a patient information sheet

Condition

Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Critical Care

Intervention

We plan to screen all patients discharged from ICU for symptoms of PTSD using questionnaires and to follow them up four weeks after discharge. After screening, patients with symptoms of PTSD would be randomly allocated to receive a brief specialised CBT-based intervention or normal aftercare.

The non-intervention arm ceases at the 4-week follow-up stage. The intervention arm using cognitive behavioural therapy has the treatment occurring at between 3 and 6 months and final follow-up to measure outcome of treatment occurring at 12 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

PTSD measurement questionnaires, measured at 3, 6, and 12 months after discharge

Secondary outcome measures

Assessed and analysed at the conclusion of the study:
1. Determine the incidence of PTSD
2. Develop a prediction score that can be used to identify the patients at risk of PTSD

Overall trial start date

01/01/2010

Overall trial end date

01/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients must be admitted to ICU for more than 24 hours
2. Patients must be older than 16 years
3. Patient must have physical and mental capacity to comprehend questions
4. The patient must be able to understand and communicate adequately in English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 200

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/01/2010

Recruitment end date

01/01/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Addenbrooke's Hospital (UK)

Sponsor details

Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html

Funders

Funder type

Research council

Funder name

Addenbrooke's Charitable Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Arthritis Research Campaign (ARC) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes