Condition category
Mental and Behavioural Disorders
Date applied
22/07/2005
Date assigned
22/07/2005
Last edited
25/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Other

Trial 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

Phase

Not Applicable

Drug names

Primary outcome measures

Severity of Posttraumatic Stress Disorder (independent assessments and self-report).

Secondary outcome measures

1. Depression
2. Anxiety
3. Disability
4. Quality of life

Overall trial start date

01/11/2003

Overall trial end date

31/03/2008

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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
United Kingdom
g.dale@iop.kcl.ac.uk

Sponsor type

University/education

Website

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24480899

Publication citations

  1. Results

    Ehlers A, Hackmann A, Grey N, Wild J, Liness S, Albert I, Deale A, Stott R, Clark DM, A randomized controlled trial of 7-day intensive and standard weekly cognitive therapy for PTSD and emotion-focused supportive therapy., Am J Psychiatry, 2014, 171, 3, 294-304, doi: 10.1176/appi.ajp.2013.13040552.

Additional files

Editorial Notes