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
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
-
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.