ISRCTN57105098进行中（未招募）未知
Supporting Hospital and Paramedic Employees (SHAPE) with cognitive and behavioural coaching for posttraumatic stress disorder and depression: a randomised controlled trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 98
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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