Randomised controlled trial of brief cognitive therapy for posttraumatic stress disorder (PTSD)
| ISRCTN | ISRCTN30480505 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30480505 |
| Secondary identifying numbers | 069777 |
- Submission date
- 12/10/2010
- Registration date
- 22/10/2010
- Last edited
- 04/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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 (UK)
2. Oxford Centre for Anxiety Disorders and Trauma, University of Oxford (UK)
When is the study starting and how long is it expected to run for?
September 2010 to May 2016
Who is funding the study?
Wellcome Trust (UK)
Who is the main contact?
Jennifer Readings
jennifer.readings@kcl.ac.uk
Contact information
Scientific
Centre for Anxiety Disorders and Trauma
University of Oxford
The Old Rectory
Paradise Square
Oxford
OX1 1TW
United Kingdom
 ORCID ID |
0000-0002-8742-0192 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomised controlled trial of brief self-study assisted and standard cognitive therapy for posttraumatic stress disorder |
| Study acronym | CTPTSD |
| Study objectives | Brief self-study assisted cognitive therapy for posttraumatic stress disorder (PTSD) is effective. |
| Ethics approval(s) | South East London Research Ethics Committee (REC) 4, 07/09/2010, ref: 10/H0807/38 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 07/09/2010 |
| Completion date | 30/05/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 90 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/10/2010 |
| Date of final enrolment | 01/07/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SE5 8AF
United Kingdom
Sponsor information
University/education
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
England
United Kingdom
| Website | http://www.iop.kcl.ac.uk/departments/?locator=26 |
|---|---|
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Charity
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/05/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
07/10/2016: The overall trial end date was changed from 31/10/2015 to 30/05/2016.
