A randomised controlled trial of cognitive therapy for post-traumatic stress disorder related to civil conflict in Northern Ireland

ISRCTN	ISRCTN16228473
DOI	https://doi.org/10.1186/ISRCTN16228473
Protocol serial number	037158 and 069777
Sponsor	The Northern Ireland Centre for Trauma and Transformation (UK)
Funders	The Northern Ireland Office (UK), The Wellcome Trust (UK) (refs: 037158 and 069777)

Submission date: 30/03/2006
Registration date: 30/03/2006
Last edited: 20/12/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Michael Duffy
Scientific

The Northern Ireland Centre for Trauma and Transformation
2 Retreat Close
Killyclogher Road
Omagh
BT79 OHW
United Kingdom

Phone	+44 (0)28 8225 1500
Email	michael.duffy@qub.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To determine whether cognitive therapy is an effective treatment for Post-Traumatic Stress Disorder (PTSD) resulting from civil conflict.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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)
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/03/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	60
Key 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
Key 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
Date of first enrolment	01/08/2003
Date of final enrolment	01/03/2006

Locations

Countries of recruitment

United Kingdom

Study participating centre

The Northern Ireland Centre for Trauma and Transformation

Omagh
BT79 OHW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	02/06/2007		Yes	No