Post-traumatic stress disorder and major depression in patient-facing health and social care professionals Mental and Behavioural Disorders
Conditions
Interventions
Current interventions as of 05/04/2024:
Interested participants will be directed to the study's online information sheet and consent form. After reading the information sheet, if a participant is stil
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 05/04/2024: 1. Patient-facing health or social care worker – professions include: nurse, doctor, paramedic, care worker, ambulance service team member, midwife, allied health professional, mental health professional, healthcare support worker, medical associate, pharmacist, care assistant, or student training to deliver health or social care 2. Aged 18 years and older 3. Willing and able to provide informed consent 4. PTSD or major depression as their primary disorder 4.1. Score 20 or above on PCL-5 (PTSD) 4.2. Score 10 or above on PHQ-9 (Depression) 4.3. Diagnosed with PTSD or major depression on the SCID-5 5. Health and social care staff who are willing to be randomised 6. If taking psychotropic medication, the dose must be stable for at least 1 month before randomisation and remain stable throughout the trial 7. If currently receiving psychological therapy, this treatment must have ended before randomisation 8. Their current reexperiencing symptoms are linked to 1–3 discrete traumatic events Previous inclusion criteria as of 20/07/2023: 1. Patient-facing health or social care worker – professions include: nurse, doctor, paramedic, ambulance service team member, midwife, allied health professional, mental health professional, healthcare support worker, medical associate, pharmacist, and nursing or medical student working in a hospital setting 2. Aged 18 years or older 3. Willing and able to provide informed consent 4. PTSD or major depression as their primary disorder 4.1. Score 20 or above on PCL-5 (PTSD) 4.2. Score 10 or above on PHQ-9 (Depression) 4.3. Diagnosed with PTSD or major depression on the SCID-5 5. Healthcare staff who are willing to be randomised 6. If taking psychotropic medication, the dose must be stable for at least 1 month before randomisation and remain stable throughout the trial 7. If currently receiving psychological therapy, this treatment must have ended before randomisation 8. Their current reexperiencing symptoms are linked to 1–3 discrete traumatic events Original inclusion criteria: 1. Patient-facing health or social care worker – professions include: nurse, doctor, paramedic, ambulance service team member, midwife, allied health professional, mental health professional, healthcare support worker, medical associate, pharmacist, and nursing or medical student working in a hospital setting 2. Aged 18 years or older 3. PTSD or major depression as their primary disorder 3.1. Score 20 or above on PCL-5 (PTSD) 3.2. Score 10 or above on PHQ-9 (Depression) 3.3. Diagnosed with PTSD or major depression on the SCID-5 4. Healthcare staff who are willing to be randomised 6. Healthcare staff who are willing to remain on a stable dose of psychotropic medication for a mental health disorder if they are currently taking medication for it 7. Healthcare staff who are willing to not receive any other mental health treatment whilst in the RCT
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 05/04/2024: 1. Health and social care staff who do not have patient-facing roles e.g., administrators, lab technicians, receptionists, and maintenance workers. 2. Health and social care staff who do not meet DSM-5 criteria for PTSD and/or major depression 3. Health and social care staff who have a different primary disorder to PTSD or depression 4. Health and social care staff who present with imminent, persistent, clinically significant risk 5. Health and social care staff who request face-to-face treatment for PTSD or depression 6. Health and social care staff who would prefer a counselling approach or Improving Access to Psychological Therapies (IAPT) 7. Health and social care staff unwilling to be randomised or to stay on a stable dose of their current medication for a mental illness or to refrain from seeking other mental health support during the trial Previous exclusion criteria: 1. Healthcare staff who do not have patient-facing roles e.g., administrators, lab technicians, receptionists, and maintenance workers. 2. Healthcare staff who do not meet DSM-5 criteria for PTSD and/or major depression 3. Healthcare staff who have a different primary disorder to PTSD or depression 4. Healthcare staff who present with imminent, persistent, clinically significant risk 5. Healthcare staff who request face-to-face treatment for PTSD or depression 6. Healthcare staff who would prefer a counselling approach or Improving Access to Psychological Therapies (IAPT) 7. Healthcare staff unwilling to be randomised or to stay on a stable dose of their current medication for a mental illness or to refrain from seeking other mental health support during the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PTSD and major depressive disorder diagnoses measured using the DSM-5 SCID-5 clinician-administered assessment at 8 weeks post-intervention/post-waitlist | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 20/07/2023: 1. PTSD and major depressive disorder diagnoses measured using the DSM-5 SCID-5 clinician-administered assessment at 6 months follow-up 2. Severity of PTSD, major depressive disorder, and generalised anxiety disorder symptoms, measured using the PTSD Checklist for DSM-5 (PCL-5), Patient Health Questionnaire (PHQ-9), and Generalised Anxiety Disorder Assessment (GAD-7) self-report scales respectively at baseline (pre-intervention/waitlist), 4 weeks (intervention/waitlist), 8 weeks (post-intervention/ waitlist), and at 6 months follow-up 3. Severity of complex PTSD and insomnia symptoms, measured using the International Trauma Questionnaire (ITQ), and the Insomnia Severity Index (ISI) self-report scales respectively at baseline (pre-intervention/waitlist), and 8 weeks (post-intervention/waitlist) 4. Rumination, responses to unwanted memories, and maladaptive appraisals, measured using the Response to Intrusions Questionnaire (RIQ-short), and the Post Traumatic Cognitions Inventory (PTCI-short) at baseline, 4 weeks (intervention/waitlist), 8 weeks (post-intervention /waitlist), and at 6 months follow-up 5. Resilience and well-being, measured using the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS), the Connor Davidson Resilience Scale -25 (CD-RISC-25), and two social support scales adapted from a brief measure of social support (Sarason et al., 1987) at baseline, 8 weeks (post-intervention/waitlist), and at 6 months follow-up 6. Health economics outcomes, measured using the iMTA Productivity Cost Questionnaire short (PCQ), Short Form Health and Labor Questionnaire (SF-HLQ), Client Service Receipt Inventory (CSRI) (edited), Recovering Quality of Life (Re-QoL) and the Quality of Life (EQ-5DL), collected at baseline, post-intervention/waitlist, and at 6 months follow-up 7. Qualitative outcomes of the SHAPE intervention, collected in the format of semi-structured interviews at post-intervention Previous secondary outc | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactJasmine Laing
Outcome results
None listed