A randomised controlled trial of therapist-assisted online psychological therapies for post-traumatic stress disorder

ISRCTN	ISRCTN16806208
DOI	https://doi.org/10.1186/ISRCTN16806208
Integrated Research Application System (IRAS)	224759
Protocol serial number	REC 13041, IRAS 224759, Protocol Version 2, 25th November 2018, 200796/Z/16/Z
Sponsor	University of Oxford
Funder	Wellcome Trust

Submission date: 15/12/2017
Registration date: 05/01/2018
Last edited: 03/04/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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 Poppy Green, poppy.green@psy.ox.ac.uk

Contact information

Miss Poppy Green
Public

Oxford Centre for Anxiety Disorders and Trauma
University of Oxford
Paradise Square
Oxford
OX1 1TW
United Kingdom

Phone	+44 (0)1865 281867
Email	poppy.green@psy.ox.ac.uk

Prof Anke Ehlers
Scientific

Oxford Centre for Anxiety Disorders and Trauma
University of Oxford
Paradise Square
Oxford
OX1 1TW
United Kingdom

ORCID ID	0000-0002-8742-0192

Study information

Primary study design	Interventional
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomiSed controlled Trial of therapist-assisted Online Psychological therapies for Post-Traumatic Stress Disorder
Study acronym	STOP-PTSD
Study objectives	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(s)	West Midlands - Black Country Research Ethics Committee, ref: 17/WM/0441
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	217
Total final enrolment	217
Key inclusion criteria	1. Aged 18 years 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
Key exclusion criteria	1. History of psychosis 2. Current substance dependence 3. Current borderline personality disorder 4. Acute serious suicide risk
Date of first enrolment	15/01/2018
Date of final enrolment	31/03/2020

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

University of Oxford

Centre for Anxiety Disorders and Trauma
Paradise Square
Oxford
OX1 1TW
United Kingdom

Institute for Psychiatry, Psychology and Neuroscience, King's College London

De Crespigny Park
London
SE5 8AF
United Kingdom

Oxford Health NHS Foundation Trust

Oxford
OX3 7JX
United Kingdom

South London and Maudsley NHS Foundation Trust

BR3 3BX
United Kingdom

Sussex Partnership NHS Foundation Trust

BN13 3EP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/08/2023	24/07/2023	Yes	No
Protocol article		23/04/2020	11/08/2022	Yes	No
HRA research summary			28/06/2023	No	No
Other publications	Economic evaluation	26/03/2024	03/04/2024	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Preprint results		22/03/2023	30/03/2023	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

03/04/2024: Publication reference added.
24/07/2023: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
30/03/2023: The following changes were made to the trial record:
1. The contact was changed.
2. A link to preprint results was added.
11/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
23/09/2020: Internal review.
07/05/2020: The recruitment end date was changed from 21/04/2020 to 31/03/2020.
23/04/2020: The recruitment end date was changed from 30/06/2020 to 21/04/2020.
05/12/2019: The recruitment end date has been changed from 30/09/2020 to 30/06/2020.
06/11/2019: IPD sharing statement added.
05/11/2019: The following changes were made to the trial record:
1. Contact details, secondary outcome measures and inclusion criteria were updated.
2. Protocol Version changed from Protocol Version 1, 9th November 2017 to Protocol Version 2, 25th November 2018.
3. The target number of participants was changed from 175 to 217.