Contact information
Type
Scientific
Contact name
Prof Anke Ehlers
ORCID ID
Contact details
King's College London
Institute of Psychiatry
Department of Psychology
PO77
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 5033
a.ehlers@iop.kcl.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
069777
Study information
Scientific title
A randomised controlled trial of weekly and intensive cognitive therapy for post-traumatic stress disorder and supportive therapy
Acronym
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.
Ethics approval(s)
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Condition
Post-traumatic stress disorder (PTSD)
Intervention
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.
Intervention type
Other
Primary outcome measure
Severity of Posttraumatic Stress Disorder (independent assessments and self-report).
Secondary outcome measures
1. Depression
2. Anxiety
3. Disability
4. Quality of life
Overall study start date
01/11/2003
Overall study end date
31/03/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
120
Participant 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
Recruitment start date
01/11/2003
Recruitment end date
31/03/2008
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
King's College London
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
United Kingdom
g.dale@iop.kcl.ac.uk
Sponsor type
University/education
Website
ROR
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 069777)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2014 | Yes | No |