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ISRCTN
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ISRCTN16228473
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of cognitive therapy for post-traumatic stress disorder related to civil conflict in Northern Ireland
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Scientific title
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Acronym
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N/A
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Serial number at source
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037158 and 069777
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Study hypothesis
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To determine whether cognitive therapy is an effective treatment for Post-Traumatic Stress Disorder (PTSD) resulting from civil conflict.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Post-traumatic Stress Disorder
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/08/2003
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Anticipated end date
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01/03/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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60
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Interventions
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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.
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Primary outcome measure(s)
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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)
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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1. The Northern Ireland Office (UK)
2. The Wellcome Trust (UK) (refs: 037158 and 069777)
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Trial website
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Publications
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Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17495988
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Contact name
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Mr
Michael
Duffy
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Address
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The Northern Ireland Centre for Trauma and Transformation
2 Retreat Close
Killyclogher Road
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City/town
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Omagh
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Zip/Postcode
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BT79 OHW
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Country
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United Kingdom
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Tel
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+44 (0)28 8225 1500
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Fax
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+44 (0)28 8225 5899
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Email
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michaelduffy@nictt.org
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Sponsor
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The Northern Ireland Centre for Trauma and Transformation (UK)
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Address
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c/o Mr David Bolton
2 Retreat Close
Killyclogher Road
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City/town
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Omagh
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Zip/Postcode
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BT79 OHW
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Country
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United Kingdom
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Tel
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+44 (0)28 8225 1500
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Fax
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+44 (0)28 8225 5899
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Email
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info@nictt.org
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Sponsor website:
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http://www.nictt.org
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Date applied
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30/03/2006
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Last edited
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04/08/2008
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Date ISRCTN assigned
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30/03/2006
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