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
Secondary identifying numbers 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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesTo 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) studiedPost-traumatic Stress Disorder
InterventionPatients 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 typeOther
Primary outcome measureThe 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 measuresNo secondary outcome measures
Overall study start date01/08/2003
Completion date01/03/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants60
Key inclusion criteria1. 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 criteria1. 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 enrolment01/08/2003
Date of final enrolment01/03/2006

Locations

Countries of recruitment

  • United Kingdom

Study participating centre

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

Sponsor information

The Northern Ireland Centre for Trauma and Transformation (UK)
Research organisation

c/o Mr David Bolton
2 Retreat Close
Killyclogher Road
Omagh
BT79 OHW
United Kingdom

Phone +44 (0)28 8225 1500
Email info@nictt.org
Website http://www.nictt.org

Funders

Funder type

Research organisation

The Northern Ireland Office (UK)

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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