Implementing internet-based cognitive therapy for post-traumatic stress disorder in NHS Improving Access to Psychological Therapies services
| ISRCTN | ISRCTN12462559 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12462559 |
| IRAS number | 292312 |
| Secondary identifying numbers | Version 2 23/02/2021, IRAS 292312, WT 200796/Z/16/Z, CPMS 49338 |
- Submission date
- 05/09/2021
- Registration date
- 13/09/2021
- Last edited
- 01/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Posttraumatic stress disorder (PTSD) can develop after a range of traumatic events such as interpersonal violence, accidents, disaster or war zone experiences. Cognitive therapy for PTSD (CT-PTSD) is an effective treatment for this condition. A therapist-assisted internet-delivered version of this treatment (iCT-PTSD) has also been found to be acceptable to patients and effective in research studies. Patients complete online treatment modules that cover all components of CT-PTSD at a time and place convenient to them. A therapist guides them remotely through the treatment and supports them through messages and phone calls.
The aim of this study is to investigate how effective iCT-PTSD is in routine clinical care and who benefits from it. The clinical outcomes of patients treated with iCT-PTSD will be assessed and compared to those previously observed in the services.
Who can participate?
1. People with posttraumatic stress disorder who receive treatment at one of the participating Improving Access to Psychological Therapies (IAPT) NHS services and agree to participate in the study
2. About 30 therapists from participating IAPT NHS services
What does the study involve?
For participating patients, the study involves completing the iCT-PTSD treatment programme online with the support of messages and phone calls with an IAPT therapist. It also involves completing questionnaires about symptoms, thoughts and ways of coping, and satisfaction with treatment.
Participating therapists will be trained to guide and support patients with PTSD in completing the iCT-PTSD treatment programme. They will then treat patients with PTSD with iCT-PTSD and receive supervision. At the end of the study, therapists complete a questionnaire and a focus group on their experience with delivering the treatment.
What are the possible benefits and risks of participating?
All participating patients will receive internet-based psychological therapy for PTSD with support from an IAPT therapist who has received specialist training and supervision. Undertaking treatment for PTSD can be challenging. Like in-person therapy, iCT-PTSD encourages participants to reflect on their difficulties in order to understand how PTSD works, and supports participants in tackling situations that they may have previously avoided. While doing this may temporarily increase distress, facing these challenges is an important step towards overcoming PTSD.
Where is the study run from?
The University of Oxford (UK)
When is the study starting and how long is it expected to run for?
April 2016 to December 2022
Who is funding the study?
The Wellcome Trust (UK) 200796/Z/16/Z
Who is the main contact?
Trinity de Simone
trinity.desimone@psy.ox.ac.uk
Contact information
Scientific
Department of Experimental Psychology
University of Oxford
Centre for Anxiety Disorders and Trauma
Paradise Square
Oxford
OX1 1TW
United Kingdom
 ORCID ID |
0000-0002-8742-0192 |
|---|---|
| Phone | +44 (0)1865618600 |
| anke.ehlers@psy.ox.ac.uk |
Study information
| Study design | Interventional multicenter implementation study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Internet/virtual |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A study of the implementation of Internet-based Cognitive Therapy for Post-Traumatic Stress Disorder within NHS Improving Access to Psychological Therapies (IAPT) services |
| Study acronym | OVERCOME-PTSD |
| Study objectives | iCT-PTSD clinical outcomes will meet national IAPT targets for the treatment of common mental health disorders (i.e. at least 50% of patients recover, with many others showing reliable improvement). |
| Ethics approval(s) | Approved 18/02/2021, London Brent Ethics Committee (80 London Road, Skipton House, London, SE1 6LH, UK; +44 (0)20 7104 8128, +44 (0)20 7104 8137; brent.rec@hra.nhs.uk), REC ref: 21/PR/103 |
| Health condition(s) or problem(s) studied | Post-traumatic stress disorder |
| Intervention | Cognitive therapy for PTSD (CT-PTSD) is a trauma-focused cognitive behavioural treatment for posttraumatic stress disorder recommended by NICE (2018) and international treatment guidelines. It is usually delivered in face-to-face sessions. A therapist-assisted internet-delivered version (iCT-PTSD) has recently been found to be efficacious and acceptable to patients. Patients are guided through the online treatment programme by a therapist. Patients work through the therapy modules of iCT-PTSD on a secure website, as well as completing treatment-related tasks and activities as part of their daily routine. The therapist releases the modules that are relevant to the patients and supports them through messages and phone calls. This study will evaluate the effectiveness of this treatment in IAPT services. IAPT therapists who consented to be part of the study, have been trained in iCT-PTSD and are receiving supervision. The total duration of treatment is up to 6 months, with a 3-month main treatment phase with weekly phone calls and a 3-month booster phase with monthly phone calls. |
| Intervention type | Behavioural |
| Primary outcome measure | Recovery as defined in IAPT by cut-offs on the PTSD Symptom Checklist for DSM-5 (PCL-5) and Patient Health Questionnaire (PHQ-9) at the end of weekly treatment and the end of booster treatment |
| Secondary outcome measures | 1. PTSD symptoms measured with the PCL-5 completed at baseline, 12 weeks and 24 weeks. The PCL-5 is given weekly during the weekly therapy phase as is standard in IAPT services 2. Depression symptoms measured with the PHQ-9 completed at baseline, 12 weeks and 24 weeks. The PHQ-7 is given weekly during the weekly therapy phase as is standard in IAPT services 3. Anxiety symptoms measured with the Generalised Anxiety Disorder Questionnaire (GAD-7) completed at baseline, 12 weeks and 24 weeks. The GAD-7 is given weekly during the weekly therapy phase as is standard in IAPT services 4. Disability measured with the Work and Social Adjustment Scale (WSAS) completed at baseline, 12 weeks and 24 weeks. The WSAS is given weekly during the weekly therapy phase as is standard in IAPT services 5. Satisfaction with treatment assessed with the IAPT Patient Experience Questionnaire at the end of treatment Process measures: 1. Credibility of treatment measured with the Borkovec and Nau Credibility scale at 2 weeks. 2. Working alliance measured with the Working Alliance Scale completed by patients and therapists at 2 weeks 3. Appraisals of the trauma and its sequelae measured with a short version of the Posttraumatic Cognitions Inventory (PTCIs) given at baseline and weekly during the weekly therapy phase 4. Qualities of trauma memories measured with a short version of the trauma memory questionnaire (MQ) given at baseline weekly during the weekly therapy phase 5. Responses to intrusive memories measured with a short version of the Response to Intrusions Questionnaire (RIQ) given at baseline and weekly during the weekly therapy phase 6. Safety behaviours measured with a short version of the Safety Behaviours Questonnaire (SBQ) given at baseline and weekly during the weekly therapy phase 7. Dissociation measured with a short version of the Trait-State Dissociation Questionnaire (TDSQ) given at baseline and for those with high dissociation weekly during the weekly therapy phase 8. Sleep disturbance measured with the Insomnia Sleep Index (ISI) at baseline and for those with high sleep disturbance weekly during the weekly therapy phase 9. Patient activity on the online programme such as time spent on the programme and modules completed, recorded during treatment User experience with iCT-PTSD: 1. Therapists’ experience with delivering iCT-PTSD assessed with the Therapist-Questionnaire- iCT-PTSD and focus group discussion at the end of the study 2. Patients’ experience assessed through ratings of helpfulness and free comments provided at the end of each module |
| Overall study start date | 01/04/2016 |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 360 |
| Key inclusion criteria | 1. Post-Traumatic Stress Disorder is the main psychological problem, and the patient's priority to work on in therapy 2. 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) 3. Regular, private access to an internet-enabled device and reliable internet connection 4. Able to take phone calls from their therapist within normal IAPT clinic hours, and have enough time in their week to be able to log in and work on the programme regularly (i.e. at least 20 min on 3-4 days each week) 5. Able to speak, read and write English 6. If on medication for mood/anxiety, the participant agrees to remain to stay on a stable dose |
| Key exclusion criteria | 1. Marked clinical risk based on the service's intake assessment 2. Current dependence on alcohol or substances 3. Currently participating in another clinical research study 4. Current psychosis/bipolar affective disorder/emotionally unstable personality disorder (NB. These conditions are not typically treated within IAPT services) |
| Date of first enrolment | 18/02/2021 |
| Date of final enrolment | 30/09/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Slade Site
Horspath Driftway
Oxford
OX3 7JH
United Kingdom
Skimped Hill Lane
Bracknell
RG12 1QB
United Kingdom
Jubilee Road
Workington
CA14 4HA
United Kingdom
Prospect House, Peace Drive
Watford
WD17 3XE
United Kingdom
St Pancras Hospital
4 St Pancras Way
London
NW1 0PE
United Kingdom
High Wycombe
HP13 6LA
United Kingdom
Springwood Drive
Braintree
CM7 2YN
United Kingdom
London
W6 7DJ
United Kingdom
London
W13 8RA
United Kingdom
Carlton Centre
Outer Circle Road
Lincoln
LN2 4WA
United Kingdom
Sponsor information
University/education
Clinical Trials and Research Governance
Joint Research Office, 1st Floor Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom
| Phone | +44 (0)1865 (2)89885 |
|---|---|
| ctrg@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Research organisation
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Wellcome, WT
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2023 |
|---|---|
| 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 peer-reviewed open access journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
01/10/2021: The CPMS number was added to the protocol/serial no. field.
09/09/2021: Trial's existence confirmed by the London - Brent Research Ethics Committee.
