|
ISRCTN
|
ISRCTN48524925
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Psychological treatments of post-traumatic stress disorder
|
|
Scientific title
|
A randomised controlled trial of weekly and intensive cognitive therapy for post-traumatic stress disorder and supportive therapy
|
|
Acronym
|
N/A
|
|
Serial number at source
|
069777
|
|
Study hypothesis
|
To compare the efficacy of cognitive therapy for Post-Traumatic Stress Disorder (PTSD), delivered either in weekly sessions or as a one-week intensive treatment, with supportive therapy and a wait list.
|
|
Lay summary
|
Not provided at time of registration
|
|
Ethics approval
|
1. The South London and Maudsley NHS Trust/Institute of Psychiatry Ethical Committee (Research) (ref: 197/03)
2. Oxfordshire Psychiatric Research Ethics Committee (ref: O03.038)
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Post-traumatic stress disorder (PTSD)
|
|
Participants - inclusion criteria
|
1. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of PTSD following discrete traumatic events in adulthood
2. PTSD is main problem
3. 18 to 65 years old, either sex
|
|
Participants - exclusion criteria
|
1. Borderline personality disorder
2. Psychosis
3. Current substance dependence
4. Ongoing severe threat (e.g. still living with perpetrator)
5. Treatment cannot be conducted without the aid of an interpreter
6. Not willing to accept random allocation
|
|
Anticipated start date
|
01/11/2003
|
|
Anticipated end date
|
31/03/2008
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
120
|
|
Interventions
|
Four conditions (N = 30 patients with PTSD each):
1. Weekly cognitive therapy for PTSD (12 weekly sessions and up to three monthly booster sessions)
2. Intensive cognitive therapy for PTSD, matched for therapist time
3. Supportive therapy, matched for therapist time
4. 14-week wait list
Second site is Oxford University, Department of Psychiatry.
|
|
Primary outcome measure(s)
|
Severity of Posttraumatic Stress Disorder (independent assessments and self-report).
|
|
Secondary outcome measure(s)
|
1. Depression
2. Anxiety
3. Disability
4. Quality of life
|
|
Sources of funding
|
The Wellcome Trust (UK) (grant ref: 069777)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Prof
Anke
Ehlers
|
|
Address
|
King's College London
Institute of Psychiatry
Department of Psychology, PO77
De Crespigny Park
|
|
City/town
|
London
|
|
Zip/Postcode
|
SE5 8AF
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7848 5033
|
|
Fax
|
+44 (0)20 7848 0591
|
|
Email
|
a.ehlers@iop.kcl.ac.uk
|
|
Sponsor
|
King's College London (UK)
|
|
Address
|
Institute of Psychiatry
De Crespigny Park
|
|
City/town
|
London
|
|
Zip/Postcode
|
SE5 8AF
|
|
Country
|
United Kingdom
|
|
Email
|
g.dale@iop.kcl.ac.uk
|
|
Date applied
|
22/07/2005
|
|
Last edited
|
10/11/2011
|
|
Date ISRCTN assigned
|
22/07/2005
|
