ISRCTN99573523进行中(未招募)Unknown
R&R: A phase 2 randomised controlled trial for moral injury related mental health difficulties
Forces in Mind Trust0 个研究点目标入组 46 人开始时间: 2023年6月19日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 46
研究概览
简要总结
2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38754887/ (added 21/05/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Veteran patients: The veteran must demonstrate presence of a military-attributable moral-injury related mental health difficulty confirmed via clinician assessment. Veteran participants must be willing to provide informed consent to participate in the study and consent to share treatment information with their GP as required.
排除标准
- •Veteran patients: For veteran patients who will receive R&R and TAU, no limitations on eligibility according to demographic characteristics (e.g. gender, age, rank) will be imposed. Moreover, we will not restrict participation by deployment location or military service branch.
- •We will exclude veteran participants:
- •1. Who are not aged 18 years or more
- •2. Who do not have military-attributable moral injury-related mental health problems as determined by their clinician
- •3. Have speech or hearing difficulties or serious cognitive impairment
- •4. Are actively self-harming or expressing significant suicidal ideation
- •5. Are unwilling or unable to provide informed consent
- •6. Have received trauma-focused individual therapy within last 3 months or have planned concurrent psychological therapy treatment
- •7. Who present with severe psychotic disorder (including in previous clinical diagnosis)
- •8. Who are experiencing dissociative identity disorder or other severe mental health difficulty
- •9. Who are currently experiencing significant life stressors that would impair the participant’s ability to engage in therapy (e.g. homelessness)
- •10. Who have current alcohol or drug use disorder or dependency requiring further support or treatment that would significantly impact treatment engagement, as assessed by clinician
- •11. Who do not have internet access or are unwilling to complete sessions remotely
- •12. Who participated in the R&R pilot trial and previously received R&R (added 20/06/2023)
- •Exclusion and inclusion criteria will be screened through review of patient notes following initial assessment at Combat Stress, as well as during initial pre-consent screening call with research therapist. Any patients who do not meet study inclusion criteria will be referred to services that better meet their needs by the Combat Stress clinician.
研究者
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