NHS COVID-related post-traumatic stress disorder (PTSD) experimental treatment trial
| ISRCTN | ISRCTN52834682 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52834682 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 317339 |
| Protocol serial number | CPMS 58296, NIHR203566, IRAS 317339 |
| Sponsor | King's College London |
| Funder | NIHR Central Commissioning Facility (CCF) |
- Submission date
- 05/10/2023
- Registration date
- 16/10/2023
- Last edited
- 16/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
High levels of Post-Traumatic Stress Disorder (PTSD) are reported in frontline health and social care workers (HSCW) who have worked through the pandemic. These levels of PTSD are comparable to those in military veterans who have been involved in warfare. Staff with PTSD present a patient safety risk due to high staff absences and mistakes. Currently the best treatment available for PTSD is lengthy, costly and 30% of people undertaking this treatment drop out before the end. New PTSD treatments are needed. We have developed a new Neurolinguistic Programming (NLP) treatment called Fast Imagery Reversal Script for Trauma-release (FIRST).
Our study aims to develop a FIRST treatment route for HSCW with PTSD and to develop an understanding of what their employers consider to be important health benefits for their staff. We are asking three questions: 1) Do staff want to receive treatment and participate in research and how? 2) Can NLP reconsolidation therapy training previously undertaken by veteran-charity therapists also be successfully taught to multi-professional mental health practitioners employed by the NHS? 3) What employer benefits are important to measure e.g. sickness-absence rates and/or mistakes made by staff while working.
Who can participate?
Health and social care workers over 18 years, working in NHS Trusts, Primary Care of Social Care between 1st March 2020 and 31st March 2021 covering the three UK waves of the pandemic.
What does the study involve?
The main purpose of the study will be to develop a funding application to undertake further research of FIRST to determine whether it works, how it works and is it safe compared to similar treatments. We propose a 3-phase study. Phase 1 will recruit a group of individuals directly affected by the pandemic including NHS and social care workers and patients and their families to discuss and answer the research questions. Phase 2 will train and assess four to six NHS qualified mental health practitioners in delivering FIRST. Phase 3 will deliver FIRST to twelve HSCW with PTSD to see if they will start therapy and take part as research participants.
What are the possible benefits and risks of participating?
We do not anticipate any risks for participants taking part in the FIRST therapy or exit interviews. However, talking therapies require people to talk about a problem they are currently experiencing and this can feel uncomfortable or upsetting. Your therapist is specially trained to help you manage these feelings safely.
We cannot guarantee that you will benefit from participating in our study but current research suggests that your PTSD symptoms may improve if you complete the treatment. FIRST therapy is delivered in a shorter time than standard treatment offered by SLaM.
Where is the study run from?
King’s College London (UK) and South London and Maudsley NHS Foundation Trust (UK).
When is the study starting and how long is it expected to run for?
October 2022 to March 2024
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Prof. Jackie Sturt, jackie.sturt@kcl.ac.uk
Contact information
Scientific
King’s College London
57 Waterloo Road
London
SE1 8WA
United Kingdom
 ORCID ID |
0000-0003-1281-1401 |
|---|---|
| jackie.sturt@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional non randomized |
| Secondary study design | Non randomised study |
| Participant information sheet | 44365 MHP interview PIS v2.0 31Aug23.pdf |
| Scientific title | Evaluating a brief novel treatment for COVID-related Post-Traumatic Stress Disorder (PTSD) in the Health and Social Care workforce: a pre-RCT preparatory study |
| Study acronym | NHS PETT |
| Study objectives | We can successfully recruit and train mental health practitioners working within the NHS to competently deliver FIRST therapy to health and social care workers within the NHS, and that these health and social care workers will present for, commence and complete FIRST therapy |
| Ethics approval(s) |
Approved 05/10/2023, East of Scotland Research Ethics Service (EoSRES) (Tayside Medical Science Centre, George Pirie Way, Ninewells Hospital, Dundee, DD1 9SY, United Kingdom; +44 1382 383878; tay.eosres@nhs.scot), ref: LR/23/ES/0037 |
| Health condition(s) or problem(s) studied | Post-Traumatic Stress Disorder (PTSD) |
| Intervention | We are using a novel therapy called Fast Imagery Reversal Script for Trauma-release (FIRST) which is a possible new treatment for PTSD. FIRST draws on NLP (neurolinguistic programming) approaches and reconsolidation processes to deliver a therapy in which the person is asked to visualise in a way that is intended to be comfortable, non-traumatising, and non-intrusive. At no point is the person asked to describe the detail of the experiences that lead to their PTSD. The treatment is offered in up to four weekly individual session of 90 minutes duration. As well as completion at baseline, participants will be asked to complete a series of questionnaires at completion of the FIRST therapy and at four weeks after their last FIRST session. Participants will also be asked to take part in an exit interview for which they will have provided informed consent. Interviews will last approximately 45 minutes and will take place online (via Microsoft Teams). |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
To understand the feasibility and acceptability of FIRST therapy for HSCWs and MHPs. Feasibility and acceptability will be assessed via the qualitative exit interviews and will answer these questions: |
| Key secondary outcome measure(s) |
Mental health outcomes collected at baseline and four weeks’ post end-of-therapy; and PCL-5 and GAD-7 will also be collected at completion of therapy (approx. four weeks’ post baseline): |
| Completion date | 30/03/2024 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 18 |
| Key inclusion criteria | 1. Adults > = 18 years 2. Working in NHS Trusts, Primary Care or Social Care between 1st March 2020 and 31st March 2021 covering the three UK waves of the pandemic. 3. Prior, or new, diagnosis of PTSD determined by a PCL-5 score > 32. Confirmed by the Staff Counselling and Wellbeing Service or Post-Incident Pathway, within SLaM. |
| Key exclusion criteria | 1. Currently receiving psychological treatment for PTSD. 2. Not able to provide informed consent. 3. Unwilling to consent to video-recording of therapy sessions for supervisory purposes. |
| Date of first enrolment | 01/11/2023 |
| Date of final enrolment | 31/01/2024 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
Monks Orchard Road
Beckenham
BR3 3BX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Interview information sheet for NHS qualified mental health practitioners version 2.0 |
31/08/2023 | 16/10/2023 | No | Yes |
| Participant information sheet | Study information sheet for NHS qualified mental health practitioners version 2.0 |
31/08/2023 | 16/10/2023 | No | Yes |
| Participant information sheet | for Health and Social Care workers version 3.0 |
31/08/2023 | 16/10/2023 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 44365 HSCW PIS v3.0 31Aug23.pdf
- for Health and Social Care workers
- 44365 MHP study PIS v2.0 31Aug23.pdf
- Study information sheet for NHS qualified mental health practitioners
- 44365 MHP interview PIS v2.0 31Aug23.pdf
- Interview information sheet for NHS qualified mental health practitioners
Editorial Notes
05/10/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
