A randomised controlled trial of therapist-assisted online psychological therapies for post-traumatic stress disorder
| ISRCTN | ISRCTN16806208 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16806208 |
| IRAS number | 224759 |
| Secondary identifying numbers | REC 13041, IRAS 224759, Protocol Version 2, 25th November 2018, 200796/Z/16/Z |
- 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
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
Public
Oxford Centre for Anxiety Disorders and Trauma
University of Oxford
Paradise Square
Oxford
OX1 1TW
United Kingdom
| Phone | +44 (0)1865 281867 |
|---|---|
| poppy.green@psy.ox.ac.uk |
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
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a 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 | 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 study start date | 01/01/2017 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centres
Paradise Square
Oxford
OX1 1TW
United Kingdom
London
SE5 8AF
United Kingdom
OX3 7JX
United Kingdom
United Kingdom
United Kingdom
Sponsor information
University/education
Clinical Trials and Research Goverance
Joint Research Office
Block 60
Churchill Hospital
Headington
Oxford
OX3 7LE
England
United Kingdom
"ROR" |
https://ror.org/052gg0110 |
|---|
Funders
Funder type
Research organisation
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results will be published in peer-reviewed scientific journals with open access, as per Wellcome Trust policy |
| 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? |
|---|---|---|---|---|---|
| Protocol article | 23/04/2020 | 11/08/2022 | Yes | No | |
| Preprint results | 22/03/2023 | 30/03/2023 | No | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 01/08/2023 | 24/07/2023 | Yes | No | |
| Other publications | Economic evaluation | 26/03/2024 | 03/04/2024 | Yes | No |
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.
