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A randomised controlled trial of cognitive therapy for post-traumatic stress disorder related to civil conflict in Northern Ireland
ISRCTN ISRCTN16228473
DOI 10.1186/ISRCTN16228473
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised controlled trial of cognitive therapy for post-traumatic stress disorder related to civil conflict in Northern Ireland
Scientific title
Acronym N/A
Serial number at source 037158 and 069777
Study hypothesis To determine whether cognitive therapy is an effective treatment for Post-Traumatic Stress Disorder (PTSD) resulting from civil conflict.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Post-traumatic Stress Disorder
Participants - 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
Participants - 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
Anticipated start date 01/08/2003
Anticipated end date 01/03/2006
Status of trial Completed
Patient information material
Target number of participants 60
Interventions 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.
Primary outcome measure(s) 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 measure(s) No secondary outcome measures
Sources of funding 1. The Northern Ireland Office (UK)
2. The Wellcome Trust (UK) (refs: 037158 and 069777)
Trial website
Publications 1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17495988
Contact name Mr  Michael  Duffy
  Address The Northern Ireland Centre for Trauma and Transformation
2 Retreat Close
Killyclogher Road
  City/town Omagh
  Zip/Postcode BT79 OHW
  Country United Kingdom
  Tel +44 (0)28 8225 1500
  Fax +44 (0)28 8225 5899
  Email michael.duffy@qub.ac.uk
Sponsor The Northern Ireland Centre for Trauma and Transformation (UK)
  Address c/o Mr David Bolton
2 Retreat Close
Killyclogher Road
  City/town Omagh
  Zip/Postcode BT79 OHW
  Country United Kingdom
  Tel +44 (0)28 8225 1500
  Fax +44 (0)28 8225 5899
  Email info@nictt.org
  Sponsor website: http://www.nictt.org
Date applied 30/03/2006
Last edited 20/12/2012
Date ISRCTN assigned 30/03/2006
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