Plain English Summary
Background and study aims
Post-traumatic stress disorder (PTSD) is an anxiety disorder caused by very stressful, frightening or distressing events. Research shows that PTSD can be treated effectively with psychological treatments. However, many patients with PTSD are currently unable to access effective psychological treatments for a range of reasons, such as shortage of therapists, living too far away from treatment centres, or being unable to attend therapy during usual working hours. Given the large number of people suffering from PTSD, it is desirable to develop more efficient forms of treatment delivery that can be widely accessed, and online treatment delivery appears to be a promising alternative to face-to-face therapy. There is already some evidence that therapist-assisted online psychological treatments are effective in PTSD. The aim of this study is to compare two forms of therapist-supported internet-based psychological therapy for PTSD. The online therapies are based on effective face-to-face therapies (cognitive therapy, stress management therapy). Both treatments are compared with a wait-list to control for the natural recovery that is sometimes seen in PTSD.
Who can participate?
Patients aged 18 or above who suffer from PTSD resulting from traumatic events experienced in adulthood
What does the study involve?
Participants’ symptoms of PTSD, depression, anxiety and functioning are assessed and they are randomly allocated to receive either one of the two internet-delivered psychological therapies immediately or after a delay of 13 weeks. The assessments are repeated at 6 weeks, the end of therapy/waiting, and 3, 6 and 12 months after the end of therapy. Therapy involves completing therapy modules online and assignments over 3 months, with guidance via messages and weekly phone calls with an experienced psychological therapist. An evaluation of the process of how symptoms change is treatment is also undertaken by collecting weekly questionnaires and by interviewing participants regarding their experiences.
What are the possible benefits and risks of participating?
All participants receive internet-delivered psychological therapy with support from a therapist for their PTSD. A team that specialises in the treatment of this disorder delivers the treatment and closely monitors progress. There is a 14% chance that participants are randomly selected to wait for 13 weeks before starting treatment. Some people may experience a temporary increase in distress as a result of remembering the trauma during treatment, but this is usually short-lived.
Where is the study run from?
1. University of Oxford (UK)
2. Institute for Psychiatry, Psychology and Neuroscience, King's College London (UK)
3. Oxford Health NHS Foundation Trust (UK)
4. South London and Maudsley NHS Foundation Trust (UK)
5. Sussex Partnership NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
January 2017 to December 2021
Who is funding the study?
Wellcome Trust (UK)
Who is the main contact?
Miss Rachel Maddox
rachel.maddox@psy.ox.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Miss Rachel Maddox
ORCID ID
Contact details
Oxford Centre for Anxiety Disorders and Trauma
University of Oxford
Paradise Square
Oxford
OX1 1TW
United Kingdom
+44 (0)1865 281867
rachel.maddox@psy.ox.ac.uk
Type
Scientific
Additional contact
Prof Anke Ehlers
ORCID ID
http://orcid.org/0000-0002-8742-0192
Contact details
Oxford Centre for Anxiety Disorders and Trauma
University of Oxford
Paradise Square
Oxford
OX1 1TW
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
REC: 13041; IRAS: 224759; Protocol Version 2, 25th November 2018
Study information
Scientific title
A randomiSed controlled Trial of therapist-assisted Online Psychological therapies for Post-Traumatic Stress Disorder
Acronym
STOP-PTSD
Study hypothesis
Is internet-delivered cognitive therapy for PTSD more efficacious than internet-delivered stress-management for PTSD, i.e. does it lead to greater improvement in PTSD symptoms?
Ethics approval
West Midlands - Black Country Research Ethics Committee, 17/WM/0441
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Post-traumatic stress disorder
Intervention
Participants’ symptoms of PTSD, depression, anxiety and functioning are assessed and they are randomised (minimisation with a random component) at a 3:3:1 ratio to either:
1. Internet-delivered cognitive therapy for PTSD (iCT-PTSD)
2. Internet-delivered stress-management for PTSD (iStress)
3. 13-week waitlist
The assessments are repeated at 6 weeks, the end of therapy/waiting, and 3, 6 and 12 months after the end of therapy. Therapy involves completing therapy modules online and assignments over 3 months, with guidance via messages and weekly phone calls with an experienced psychological therapists. An evaluation of the process of how symptoms change is treatment is also undertaken by collecting weekly questionnaires and by interviewing participants regarding their experiences.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
PTSD symptoms measured with PTSD Symptom Checklist 5 at baseline, 6, 13 weeks after random allocation (with follow-ups at 26, 39 and 65 weeks), and weekly during treatment
Secondary outcome measures
1. Assessor ratings of PTSD symptoms, assessed with the Clinician Administered PTSD Scale for DSM 5 (CAPS-5) at baseline and 13 weeks after random allocation (with follow-ups at 26, 39 and 65 weeks).
2. Other symptom measures assessed at baseline, 6, 13 weeks after random allocation (with follow-ups at 26, 39 and 65 weeks), and weekly during treatment:
2.1. Depression, assessed with the Patient Health Questionnaire (PHQ-9)
2.2. Anxiety, assessed with the Generalized Anxiety Disorder Scale 7-items (GAD-7)
2.3. Disability, assessed with the Work and Social Adjustment Scale (WSAS)
2.4. Sleep problems, assessed with the Insomnia Sleep Index (ISI)
2.5 Well-being, assessed with the WHO-Five Wellbeing-Scale (added 05/11/2019)
2.6. Quality of life, assessed with the Endicott Quality of Life Scale (added 05/11/2019)
3. Health economics measures (Euroqol EQ-5D-5L12, iMTA Productivity Cost Questionnaire (PCQ), Endicott Quality of Life Scale (QoL), Client Service Receipt Inventory (CSRI), employment status and state benefits), assessed at baseline, 13, 26 and 39 weeks
4. Process measures assessed at baseline, 6, 13, 26, 39 weeks after random allocation (and some weekly during treatment):
4.1. Excessively negative appraisals, assessed with the Posttraumatic Cognitions Inventory (PTCI), short version
4.2. Disjointed memories, assessed with the Trauma Memory Questionnaire (MQ), short version
4.3. Unhelpful strategies to deal with intrusive memories, assessed with the Response to Intrusion Questionnaire (RIQ)
4.4. Safety behaviours, assessed with the short version Safety Behaviours Questionnaire (SBQ)
4.5. Dissociation, assessed with the short version State-Trait Dissociation Questionnaire (TSDQ)
4.6. Self-efficacy, assessed with the short version Generalized Self Efficacy Scale (GSES)
Other process measures:
1. Therapeutic alliance, assessed using the Working Alliance Inventory (WAI) at weeks 2 and 6
2. Patient satisfaction and comments on their experience with online therapy, assessed using Online Treatment Experience Interview at week 13
Overall trial start date
01/01/2017
Overall trial end date
31/12/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 and above
2. Diagnosis of Posttraumatic Stress Disorder (as assessed with the Structured Clinical Interview for DSM-5)
3. The current reexperiencing symptoms are linked to one or two discrete traumatic events experienced in adulthood.
Updated 05/11/2019: Their current reexperiencing symptoms are linked to one or two discrete traumatic events that they experienced in adulthood or adolescence, or several traumatic episodes during a longer period of high threat (e.g., domestic abuse, war zone experiences)
4. PTSD is the main psychological problem needing treatment
5. Willing and able to provide informed consent
6. Able to read and write in English
7. Access to internet
8. Willing to be randomly allocated to one of the psychological treatments or wait
9. If taking psychotropic medication, the dose must be stable for at least 1 month before randomisation
10. If currently receiving psychological therapy for PTSD, this treatment must have ended before randomisation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
217
Participant exclusion criteria
1. History of psychosis
2. Current substance dependence
3. Current borderline personality disorder
4. Acute serious suicide risk
Recruitment start date
15/01/2018
Recruitment end date
30/06/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Oxford
Centre for Anxiety Disorders and Trauma
Paradise Square
Oxford
OX1 1TW
United Kingdom
Trial participating centre
Institute for Psychiatry, Psychology and Neuroscience, King's College London
De Crespigny Park
London
SE5 8AF
United Kingdom
Trial participating centre
Oxford Health NHS Foundation Trust
Oxford
OX3 7JX
United Kingdom
Trial participating centre
South London and Maudsley NHS Foundation Trust
BR3 3BX
United Kingdom
Trial participating centre
Sussex Partnership NHS Foundation Trust
BN13 3EP
United Kingdom
Funders
Funder type
Research organisation
Funder name
Wellcome Trust
Alternative name(s)
Wellcome
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The results will be published in peer-reviewed scientific journals with open access, as per Wellcome Trust policy
IPD sharing statement
Given the sensitive nature of the study data, participants will be asked for optional consent to share their anonymised data with other researchers. For participants who consent to data-sharing, anonymised data will be available upon request from Prof. Anke Ehlers (anke.ehlers@psy.ox.ac.uk), after publication of the results of the trial and process analyses so that they can be used for meta-analyses or specified additional analyses.
Intention to publish date
31/12/2023
Participant level data
Available on request
Basic results (scientific)
Publication list