Condition category
Mental and Behavioural Disorders
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
15/07/2009
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

Miss Catherine Scholes

ORCID ID

Contact details

Clinical Psychology
114 St Anthony Road
Sheffield
S10 1SG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0071137440

Study information

Scientific title

Acronym

Study hypothesis

The aims of the study are:
1. To assess the relationship between giving self-help information to traumatic injury patients with symptoms of Acute Stress Disorder (with or without acute dissociation) and subsequent symptom severity.
2. To identify potential predictors of those patients who will benefit from self-help information.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Mental and Behavioural Disorders: Acute stress disorders

Intervention

The study will employ a between-groups repeated measures design to assess psychological sequelae and quality of life for individuals experiencing symptoms of Acute Stress Disorder (ASD) following attendance at Accident and Emergency after a traumatic event.
There will be three different groups:
Group 1- the Information group - will consist of patients with symptoms of Acute Stress Disorder who receive the self-help booklet within one month of their traumatic injury;
Group 2 - the Waiting List Control group - will consist of patients with symptoms of Acute Stress Disorder who receive the self-help booklet at the end of the study period;
Group 3 - the non-ASD Control Group- will consist of patients without symptoms of Acute Stress Disorder who receive the self-help booklet at the end of the study period.
These groups will be assessed at three points in time (within one month of the trauma, three months posttrauma and six months posttrauma).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2003

Overall trial end date

30/09/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Two Acute Stress Disorder groups
1.1 Accident and Emergency patients involved in road traffic accidents, assaults and occupational injuries of at least moderate severity between the months of July 2003 and January 2004.
1.2 meet the cut-off criteria for Acute Stress Disorder symptomatology (with or without dissociation)
1.3 consent to participate in the study
1.4 between the ages of 18 and 65.
2. Non-Acute Stress Disorder control group
2.1 patients who have had an accident of at least moderate severity
2.2 do not meet the cut-off criteria for Acute Stress Disorder symptomatology

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. suffering from a psychotic illness
2. learning disability
3. head injury
4. illiterate or do not speak English

Recruitment start date

01/08/2003

Recruitment end date

30/09/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Psychology
Sheffield
S10 1SG
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Research council

Funder name

Sheffield Health and Social Research Consortium (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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17662689

Publication citations

  1. Results

    Scholes C, Turpin G, Mason S, A randomised controlled trial to assess the effectiveness of providing self-help information to people with symptoms of acute stress disorder following a traumatic injury., Behav Res Ther, 2007, 45, 11, 2527-2536, doi: 10.1016/j.brat.2007.06.009.

Additional files

Editorial Notes