Condition category
Mental and Behavioural Disorders
Date applied
12/10/2010
Date assigned
22/10/2010
Last edited
07/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Recent research indicates that posttraumatic stress disorder can be treated effectively. The study compares two forms of a psychological treatment for posttraumatic stress disorder named Cognitive Therapy for PTSD. There is already evidence that this treatment is effective, but we do not know what way of delivering the treatment is the most effective and most acceptable to patients.

Who can participate?
Adults suffering from posttraumatic stress disorder as a result of traumas in adulthood (e.g., assault, accidents, disaster) who can regularly attend treatment sessions either in South London or Oxford.

What does the study involve?
Participants will receive one of the two forms of psychological treatment for posttraumatic stress disorder that are being compared in the study. No drugs are involved in the treatment. Two thirds of the participants will start treatment right away. The remaining third will wait 3 months before starting treatment, and will then receive one of the forms of psychological treatment. The decision about which treatment participants receive and when they start treatment will be made by chance.
In the first three months of treatment, participants receive either up to 12 weekly sessions with a therapist or up to 6 sessions with a therapist and 6 home sessions where they work through the therapy materials at their own pace. In the following three months, they receive either up to 3 or up to 2 further sessions with the therapist. Before and after treatment (or waiting for treatment), participants complete a number of assessments to monitor their improvement. They are interviewed and asked to fill in a number of questionnaires before, midway through and after the first three months of treatment, and three months, six months, one year and two years later.

What are the possible benefits and risks of participating?
All participants will receive an effective psychological treatment. The treatment involves talking and writing about the participants' memories of their trauma, and participants may experience short-term distress when confronting their memories. The discussion of the traumatic experience will be handled with sensitivity. Previous results showed that the treatment is well tolerated.

Where is the study run from?
1. Centre for Anxiety Disorders and Trauma, South London and Maudsley NHS Foundation Trust, London in collaboration with the Institute of Psychiatry, King's College London.
2. Oxford Centre for Anxiety Disorders and Trauma, University of Oxford

When is the study starting and how long is it expected to run for?
Recruitment started October 2010. Anticipated end of recruitment: July 2013.

Who is funding the study?
The Wellcome Trust (UK).

Who is the main contact?
Jennifer Readings
jennifer.readings@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Anke Ehlers

ORCID ID

Contact details

Psychology PO77
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

069777

Study information

Scientific title

A randomised controlled trial of brief self-study assisted and standard cognitive therapy for posttraumatic stress disorder

Acronym

CTPTSD

Study hypothesis

Brief self-study assisted cognitive therapy for posttraumatic stress disorder (PTSD) is effective.

Ethics approval

South East London Research Ethics Committee (REC) 4, 07/09/2010, ref: 10/H0807/38

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Posttraumatic stress disorder

Intervention

1. Brief self-study assisted cognitive therapy for PTSD: up to 12 weekly sessions over 13 weeks, plus up to 3 sessions over next 3 months, last follow-up 2 years after end of weekly sessions
2. Standard cognitive therapy for PTSD: up to 6 sessions over 13 weeks, plus up to 2 sessions over next 3 months, follow-up 2 years after 13 week assessment
3. Wait list: 13 weeks wait, then random allocation to either standard or brief CT

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Measured at initial assessment and 13, 26, 39, 65 and 117 weeks:
1. Clinician-Administered PTSD Scale (CAPS)
2. Posttraumatic Diagnostic Scale (PDS)
3. Percent meeting DSM-IV criteria for PTSD

Secondary outcome measures

Measured at initial assessment and 13, 26, 39, 65 and 117 weeks:
1. Beck Depression Inventory
2. Beck Anxiety Inventory
3. Work and Social Adjustment Scale
4. Endicott Quality of Life Scale
5. Client Satisfaction Questionnaire

Overall trial start date

07/09/2010

Overall trial end date

30/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of PTSD
2. Current PTSD is linked to 1 to 2 discrete traumas
3. PTSD is the main mental health problem requiring treatment
4. Willing to accept random allocation
5. Aged 18 years and above, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant exclusion criteria

1. Current substance dependence
2. Immediate suicide risk
3. Borderline personality disorder requiring treatment in its own right
4. History of psychosis
5. No memory for the trauma
6. Unable to conduct the therapy in English
7. Serious ongoing threat (e.g. still living with perpetrator)

Recruitment start date

01/10/2010

Recruitment end date

01/07/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Psychiatry
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

Institute of Psychiatry, Kings College London (UK)

Sponsor details

c/o Jennifer Liebscher
Research and Development Office
In collaboration with Centre for Anxiety Disorders and Trauma
South London and Maudsley NHS Foundation Trust
Room W 1.08
De Crespigny Park
London
SE5 8AF
United Kingdom

Sponsor type

University/education

Website

http://www.iop.kcl.ac.uk/departments/?locator=26

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes

07/10/2016: The overall trial end date was changed from 31/10/2015 to 30/05/2016.