ISRCTN10314773已完成未知
An external pilot randomised controlled trial to evaluate the performance of a research protocol to compare the Reconsolidation of Traumatic Memories (RTM) intervention with Trauma-Focussed CBT delivered by charities for the treatment of post-traumatic stress disorder (PTSD) in ex-military veterans
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37833734/ (added 16/10/2023)
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 19/04/2021:
- •1. Adults aged =18 years
- •2. UK military veterans from the Army, Royal Air Force or Royal Navy
- •3. PTSD (acute or chronic) diagnosis determined by DSM-5 using the Clinician Administered PTSD scale (CAPS-5) during clinical assessment with an Inspire (trial’s participating partner) employed clinical psychologist
- •4. Experiencing symptoms causing clinically significant distress or impact on social, occupational or other areas of functioning
- •5. A history of exposure to one or more traumas
- •6. Living or working in the United Kingdom
- •7. Willingness to be randomised to either treatment
- •Previous inclusion criteria from 05/11/2019 to 19/04/2021:
- •1. Adults aged =18 years
- •2. UK military veterans from the Army, Royal Air Force or Royal Navy
- •3. PTSD (acute or chronic) diagnosis determined by DSM-5 using the Clinician Administered PTSD scale (CAPS-5) during clinical assessment with an Inspire (trial’s participating partner) employed clinical psychologist
- •4. Experiencing symptoms causing clinically significant distress or impact on social, occupational or other areas of functioning
- •5. A history of exposure to one or more traumas
- •6. Living or working in Northern Ireland and within 20 miles of one of Inspire’s treatment centres which are spread across remote NI
- •7. Willingness to be randomised to either treatment
- •Previous inclusion criteria:
- •1. Adults aged =18 years
- •2. UK military veterans from the Army, Royal Air Force or Royal Navy
- •3. PTSD or complex PTSD diagnosis (acute and/or chronic) according to DSM-5 using the Clinician Administered PTSD Scale (CAPS-5) and the ICD-TQ determined during clinical assessment with an Inspire (trial's participating partner) employed consultant clinical psychologist
- •4. Experiencing symptoms causing clinically significant distress or impact on social, occupational or other areas of functioning
- •5. A history of exposure to one or more traumas
- •6. Living or working in Northern Ireland and within 20 miles of one of Inspire’s treatment centres which are spread across remote NI
- •7. Willingness to be randomised to either treatment
排除标准
- •Current exclusion criteria as of 05/11/2019:
- •1. Serving military personnel
- •2. Currently receiving psychological treatment for PTSD
- •3. Currently has a comorbid DSM-5 mental health or personality disorder sufficiently severe as to intrude upon the participant’s ability to cooperate with treatment
- •4. Current addiction to alcohol or illegal substances as determined by an AUDIT 10 cut-off of =20
- •5. Participants who had a suicide attempt within the past month at time of recruitment
- •6. Not able to provide informed consent
- •7. Self-reported medication changes in the previous 4 weeks
- •8. Unwilling to consent to audio-recording of all therapy sessions as minimum requirement
- •Previous exclusion criteria:
- •1. Serving military personnel
- •2. Currently receiving psychological treatment for PTSD
- •3. Currently has a comorbid DSM-5 mental health or personality disorder sufficiently severe as to intrude upon the participant’s ability to cooperate with treatment
- •4. Current addiction to alcohol or illegal substances as determined by an AUDIT 10 cut-off of =20
- •5. Participants who had a suicide attempt within the past month at time of recruitment
- •6. Not able to provide informed consent
- •7. Self-reported medication changes in the previous 4 weeks
- •8. Refusing to be audio recorded, which is required for treatment fidelity and data analysis
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