ISRCTN10360385进行中（未招募）未知
A randomized controlled trial of a psychological intervention for alcohol misuse and mental health comorbidities in conflict-affected populations in Uganda
IHR–Wellcome Partnership for Global Health Research0 个研究点目标入组 500 人开始时间: 2023年1月30日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
研究概览
简要总结
2024 Protocol article in https://doi.org/10.1186/s13063-024-07980-7 (added 28/02/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Adult south Sudanese men (>18 years) with a refugee status
- •2. Alcohol Use Disorder Identification Test (AUDIT score) between 8 and 20 (Saunders, Aasland, Babor, de la Fuente, et al., 1993)
- •3. Elevated levels of psychological distress (Kessler Psychological Distress Scale (10-item version) (K10>20) (Kessler et al., 2010)
- •4. Speak English and/or Juba Arabic
排除标准
- •Current exclusion criteria as of 26/05/2023:
- •1. Adult south Sudanese men (>18 years) with a refugee status
- •2. Alcohol Use Disorder Identification Test (AUDIT score <20) or no alcohol dependence (AUDIT score <8) (Saunders, Aasland, Babor, de la Fuente, et al., 1993)
- •3. Elevated levels of psychological distress (Kessler Psychological Distress Scale (10-item version) (K10>20) (Kessler et al., 2010)
- •4. Speak English and/or Juba Arabic
- •5. Have previously received PM+.
- •6. Have been in the camp for less than three months, given that new arrivals take 2 to 3 months to relocate (i.e. receive land and refugee determination status), and the first three months are more likely to be in acute stages of distress.
- •Previous exclusion criteria as of 25/04/2023:
- •1. Men with possible alcohol dependence (AUDIT score =20).
- •2. Imminent risk of suicide/other life-threatening risk, acute medical conditions assessed through three questions related to suicide (i.e., ‘in the past month, have you had serious thoughts or a plan to end your life?’, what actions have you taken to end your life? And do you plan to end your life in the next 2 weeks?). These participants will be referred to a psychiatric community officer (PCO).
- •3. Signs of severe mental disorders such as psychosis and/or severed cognitive impairment (e.g. severe intellectual disability or dementia). This will be assessed using a checklist with lists of observable signs of severe mental disorders or severe cognitive impairment such as participant not understanding questions, presenting with confused speech, appearing extremely fidgety or nervous, limited communication skills, etc).
- •4. Men who have previously received the PM+ intervention.
- •Previous exclusion criteria:
- •1. Men with possible alcohol dependence (AUDIT score =20). A validation study of the K10 in Uganda is currently being finalised, so the cut-off score may be slightly adjusted depending on the findings.
- •2. Imminent risk of suicide/other life-threatening risk, acute medical conditions assessed through three questions related to suicide (i.e., ‘in the past month, have you had serious thoughts or a plan to end your life?’, what actions have you taken to end your life? And do you plan to end your life in the next 2 weeks?). These participants will be referred to a psychiatric community officer (PCO).
- •3. Signs of severe mental disorders such as psychosis and/or severed cognitive impairment (e.g. severe intellectual disability or dementia). This will be assessed using a checklist with lists of observable signs of severe mental disorders or severe cognitive impairment such as participant not understanding questions, presenting with confused speech, appearing extremely fidgety or nervous, limited communication skills, etc)
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