A randomised controlled trial of cognitive therapy for post-traumatic stress disorder related to civil conflict in Northern Ireland
ISRCTN | ISRCTN16228473 |
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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
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 |
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michael.duffy@qub.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 | 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 study start date | 01/08/2003 |
Completion date | 01/03/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Not Specified |
Target number of participants | 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
BT79 OHW
United Kingdom
Sponsor information
The Northern Ireland Centre for Trauma and Transformation (UK)
Research organisation
Research organisation
c/o Mr David Bolton
2 Retreat Close
Killyclogher Road
Omagh
BT79 OHW
United Kingdom
Phone | +44 (0)28 8225 1500 |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 02/06/2007 | Yes | No |