Condition category
Mental and Behavioural Disorders
Date applied
30/03/2006
Date assigned
30/03/2006
Last edited
20/12/2012
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

Mr Michael Duffy

ORCID ID

Contact details

The Northern Ireland Centre for Trauma and Transformation
2 Retreat Close
Killyclogher Road
Omagh
BT79 OHW
United Kingdom
+44 (0)28 8225 1500
michael.duffy@qub.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

037158 and 069777

Study information

Scientific title

Acronym

Study hypothesis

To determine whether cognitive therapy is an effective treatment for Post-Traumatic Stress Disorder (PTSD) resulting from civil conflict.

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

Treatment

Patient information sheet

Condition

Post-traumatic Stress Disorder

Intervention

Patients suffering from PTSD who are referred to the Northern Ireland Centre for Trauma and Transformation (NICTT) in Omagh are invited to participate in the trial. Patients who agree to be included are initially randomly allocated to:
1. Immediate cognitive therapy
2. A 12 week wait-list control condition, followed by cognitive therapy

The treatment programme is the same as that used in NICTT's recently published audit of cognitive therapy in the treatment of PTSD following the 15th August 1998 car bomb in Omagh (Gillespie, Duffy, Hackman & Clark, 2002, Behaviour Research and Therapy, 40, 345-357). Patients allocated to immediate cognitive therapy receive up to 12 weekly sessions in 12 weeks, followed by a review.

Further treatment sessions are provided, if appropriate. Patients initially allocated to the wait list condition receive no treatment in the first 12 weeks but are then offered the same course of treatment. The main assessments are at pre-treatment/wait, 12 weeks, post-treatment and three and 12 month post-treatment follow-up.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome measures for the trial are:
1. The Post-traumatic Diagnosis Scale (PDS: Foa et al, 1997, Psychological Assessment, 9, 445-451)
2. The Beck Depression Inventory (BDI: Beck et al, 1979, Cognitive Therapy for Depression, Guilford Press, New York)
3. The Sheehan Disability Scale (SDS: Sheehan, 1983)

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/08/2003

Overall trial end date

01/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (American Psychiatric Association, 1994) criteria for PTSD
2. Have experienced trauma in the context of civil conflict in Northern Ireland or elsewhere
3. PTSD considered to be the patient's main problem
4. Age 18 to 70 years
5. Willing to accept random allocation

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

1. Unable to travel to Northern Ireland Centre for Trauma and Transformation (NICTT) for regular treatment sessions
2. PTSD mainly related to childhood sexual abuse
3. Other severe psychiatric or physical disorder that requires immediate treatment in its own right

Recruitment start date

01/08/2003

Recruitment end date

01/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Northern Ireland Centre for Trauma and Transformation
Omagh
BT79 OHW
United Kingdom

Sponsor information

Organisation

The Northern Ireland Centre for Trauma and Transformation (UK)

Sponsor details

c/o Mr David Bolton
2 Retreat Close
Killyclogher Road
Omagh
BT79 OHW
United Kingdom
+44 (0)28 8225 1500
info@nictt.org

Sponsor type

Research organisation

Website

http://www.nictt.org

Funders

Funder type

Research organisation

Funder name

The Northern Ireland Office (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Wellcome Trust (UK) (refs: 037158 and 069777)

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

1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17495988

Publication citations

  1. Results

    Duffy M, Gillespie K, Clark DM, Post-traumatic stress disorder in the context of terrorism and other civil conflict in Northern Ireland: randomised controlled trial., BMJ, 2007, 334, 7604, 1147, doi: 10.1136/bmj.39021.846852.BE.

Additional files

Editorial Notes