Psychological treatments of post-traumatic stress disorder

ISRCTN ISRCTN48524925
DOI https://doi.org/10.1186/ISRCTN48524925
Secondary identifying numbers 069777
Submission date
22/07/2005
Registration date
22/07/2005
Last edited
25/04/2014
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

Prof Anke Ehlers
Scientific

King's College London
Institute of Psychiatry
Department of Psychology, PO77
De Crespigny Park
London
SE5 8AF
United Kingdom

Phone +44 (0)20 7848 5033
Email a.ehlers@iop.kcl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleA randomised controlled trial of weekly and intensive cognitive therapy for post-traumatic stress disorder and supportive therapy
Study objectivesTo 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)
Health condition(s) or problem(s) studiedPost-traumatic stress disorder (PTSD)
InterventionFour 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 typeOther
Primary outcome measureSeverity of Posttraumatic Stress Disorder (independent assessments and self-report).
Secondary outcome measures1. Depression
2. Anxiety
3. Disability
4. Quality of life
Overall study start date01/11/2003
Completion date31/03/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants120
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/11/2003
Date of final enrolment31/03/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

King's College London
London
SE5 8AF
United Kingdom

Sponsor information

King's College London (UK)
University/education

Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
United Kingdom

Email g.dale@iop.kcl.ac.uk
ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

Charity

The Wellcome Trust (UK) (grant ref: 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 01/03/2014 Yes No