Multicenter RCT to evaluate the clinical and cost-effectiveness of a culturally adapted therapy (C-MAP) in patients with a history of self-harm

自杀是一个严重的全球公共卫生问题，在许多国家被列为主要死亡原因之一。在过去的45年里，全球自杀率增加了60%，预计到2020年，由自杀造成的全球疾病负担总额将从1998年的1.8%增加到2.4%。世卫组织《2013-2020年精神卫生行动计划》和所有成员国承诺努力实现到2020年将自杀率降低10%的全球目标。世卫组织的精神健康差距行动方案将自杀列为优先条件之一，世卫组织最近的报告《预防自杀：全球当务之急》呼吁将自杀预防作为全球公共卫生议程的高度优先事项。全世界每年有超过80万人死于自杀，每一次自杀就有20多人企图自杀。每一次自杀都夺走了个人的生命，并对朋友、家人和更广泛的社区产生了巨大的影响。高达75%的自杀发生在低收入和中等收入国家，这些国家用于治疗和支持有需要的人的资源和服务有限。在低收入和中等收入国家，在文化上适当的自杀预防战略的有力评估方面存在明显差距。有自我伤害史的人比没有自杀史的人自杀死亡的风险要高得多。世界卫生组织建议，为他们提供适当的治疗应该是所有自杀预防战略的关键组成部分。巴基斯坦每年发生的自残行为超过10万起。这项拟议试验的目的是评估一种文化适应心理疗法(C-MAP)在有自我伤害史的患者中的临床和成本效益。我们在卡拉奇进行了一项研究，以确定6-8次基于CBT的干预(C-MAP)对最近自我伤害的人的有效性。评估是在基线、3个月和6个月进行的。在每次随访评估中，与照常治疗(TAU)组相比，干预组在自杀意念、抑郁严重程度和绝望方面的基线水平显著降低。这项工作的发现突显了这种干预措施对巴基斯坦卫生服务的适用性，适用于自残事件后出现的患者。拟议的研究将在卡拉奇、拉合尔、拉瓦尔品第、奎达和白沙瓦进行。参与者将被随机分为干预组(C-MAP)或TAU组。现有的文化适应干预(C-MAP)包括对自我伤害事件、危机技能、问题解决和管理情绪、消极思维和复发预防策略的基本认知技能的评估。干预将在12周内分6次进行。评估将在基线和随机化后3个月(干预结束)6个月和12个月进行。结果测量将包括问卷，以衡量自我伤害的重复、自杀念头的严重程度、抑郁、绝望、生活质量和应对资源。此外，定性访谈和焦点小组将提供关于参与者和治疗师经验的丰富信息，这将为发展更有效和更敏感的自我伤害管理服务提供信息。Tau将是由当地医疗、精神科和基层保健服务机构根据其临床判断提供的标准常规护理。每名参赛者接受的任何治疗都将被记录下来。这项试验将为自我伤害的管理提供详细的临床和成本效益分析，这将为未来的研究和国家临床实践指南提供信息。我们已经与卫生部建立了联系，一旦试验完成，我们将进入讨论，向他们展示结果，并试图影响政策变化。

Suicide is a serious global public health issue ranked amongst the leading causes of death in many countries. The worldwide rates of suicide have increased by 60% in the last 45 years, and the 1.8% total global burden of disease attributed to suicide in 1998 is expected to increase to 2.4% by 2020. The WHO Mental Health Action Plan 2013-2020 and all the member states have committed to work towards the global target of a 10% reduction in the suicide rate by 2020. WHO's Mental Health Gap Action Programme includes suicide as one of the priority conditions and the recent WHO report "Preventing suicide: a global imperative" calls for suicide prevention to be a high priority on the global public health agenda. More than 800 000 people across the world die due to suicide each year and for each suicide there are more than 20 people attempting suicide. Each suicide takes the life of the individual and has a tremendous effect on friends, family and the wider community. Up to 75% of all suicides occur in in low- and middle-income countries where resources and services are limited for treatment and support for people who need. There is a clear gap in the robust evaluation of culturally appropriate suicide prevention strategies in low and middle income countries. Individuals who have a history of self-harm are at much higher risk of dying by suicide than individuals who do not have such a history. The WHO recommends that offering them appropriate treatment should be a key component of all suicide prevention strategies. There are in excess of 100,000 acts of self-harm carried out in Pakistan annually. The aim of the proposed trial is to evaluate the clinical and cost-effectiveness of a culturally adapted psychological therapy (C-MAP) in patients with a history of self-harm. We carried out a study in Karachi to determine the effectiveness of a 6-8 session CBT-based intervention (C-MAP) in people who had recently self-harmed. The assessments were carried out at baseline, 3 & 6 months. There was a significant reduction from baseline in suicidal ideation, severity of depression and hopelessness in the intervention group compared to the Treatment as Usual (TAU) group at each follow up assessment. The findings from this work have highlighted the applicability of such an intervention to health services in Pakistan for patients who present after a self-harm episode. The proposed research will be conducted in Karachi, Lahore, Rawalpindi, Quetta and Peshawar. Participants will be randomized either to the Intervention (C-MAP) or TAU. The existing culturally adapted intervention (C-MAP) includes an evaluation of the self-harm episode, crisis skills, problem solving and basic cognitive techniques to manage emotions, negative thinking and relapse prevention strategies. The intervention will be delivered in six sessions over 12 weeks. Assessments will be conducted at baseline and at 3 months (end of intervention) 6 months and 12 months after randomisation. The outcome measures will include questionnaires to measure the repetition of self-harm, severity of suicidal ideation; depression; hopelessness; quality of life and coping resources. In addition, qualitative interviews and focus groups will provide rich information regarding the experiences of participants and therapists, which will inform the development of more effective and sensitive services for self-harm management. TAU will be standard routine care delivered by local medical, psychiatric and primary care services according to their clinical judgement. A record will be kept of any treatment received by each participant. This trial will provide detailed clinical and cost-effectiveness analyses for the management of self-harm which will inform future research and national clinical practice guidelines. We have established contacts with the ministry of health and once the trial is completed we will enter discussions to present the results to them and attempt to influence policy change.