Psychological treatments of post-traumatic stress disorder

ISRCTN	ISRCTN48524925
DOI	https://doi.org/10.1186/ISRCTN48524925
Protocol serial number	069777
Sponsor	King's College London (UK)
Funder	The Wellcome Trust (UK) (grant ref: 069777)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised controlled trial of weekly and intensive cognitive therapy for post-traumatic stress disorder and supportive therapy
Study objectives	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)
Health condition(s) or problem(s) studied	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(s)	Severity of Posttraumatic Stress Disorder (independent assessments and self-report).
Key secondary outcome measure(s)	1. Depression 2. Anxiety 3. Disability 4. Quality of life
Completion date	31/03/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Key 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
Key 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
Date of first enrolment	01/11/2003
Date of final enrolment	31/03/2008

King's College London

London
SE5 8AF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2014		Yes	No