Department of Adult Psychiatry, University Hospital, Place du Pr. R. Debré, 30029, Nîmes, Cedex 9, France.
Epsylon Laboratory (EA 4556) Dynamic of Human Abilities & Health Behaviors, University of Montpellier 3, Montpellier, France.
Trials. 2020 Oct 27;21(1):889. doi: 10.1186/s13063-020-04816-y.
Suicide is a serious public health problem. The development and use of effective treatments for people hospitalized for suicide attempts remain a priority. Regarding psychosocial treatment, the evidence for treatments that effectively prevent suicide repetition of suicide attempts is extremely thin. There is some evidence that cognitive behavioural therapy may be effective for reducing suicide behaviour. The primary aim of this study is to compare Group Post-Admission Cognitive Therapy for Suicidality (GPACTS) versus Individual Supportive Therapy (IST) for preventing suicide.
In total, 240 participants with a high suicide risk score according to a Mini International Neuropsychiatric Interview (MINI) will be randomized to either GPACTS or IST. This is a multicentre, parallel group, randomized (1:1 ratio), two-tailed-superiority trial with endpoint-assessor blinding. Patients meeting inclusion criteria during a screening visit will be enrolled in the study and randomized into two groups: one group will undergo 6 weeks of GPACTS, and the second group will undergo 6 weeks of IST. Following 6 weeks of interventional therapy, patients are followed up for 12 months. Follow-up for both groups is identical and includes the administration of questionnaires at baseline and then within 10 days after the end of therapy sessions and then at 3, 6 and 12 months following the end of GPACTS/IST sessions.
To our knowledge, this is the first RCT of its kind to be conducted in France, and so far, there are no studies in the literature on group psychotherapy for the treatment of individuals who have attempted suicide. The outcomes will provide clear guidance for professionals to apply psychological intervention with suicide attempts. The protocol respects ethical principles, and ethical approval was obtained from the local ethics committee. The results will be disseminated through an original research published as original research in peer-reviewed manuscript, through a therapist manual for cognitive therapy, and presentations at research conferences.
ClinicalTrials.gov NCT02664701 . Registered on January 27, 2017.
自杀是一个严重的公共卫生问题。为试图自杀而住院的患者开发和使用有效的治疗方法仍然是当务之急。在心理社会治疗方面，预防自杀尝试再次发生的治疗方法的证据极其有限。有一些证据表明认知行为疗法可能对减少自杀行为有效。本研究的主要目的是比较入院后认知治疗自杀（GPACTS）与个体支持性治疗（IST）预防自杀的效果。
共有 240 名根据 Mini 国际神经精神访谈（MINI）自杀风险评分较高的参与者将被随机分配到 GPACTS 或 IST 组。这是一项多中心、平行组、随机（1:1 比例）、双侧优效性试验，采用终点评估者盲法。在筛选就诊时符合纳入标准的患者将被纳入研究并随机分为两组：一组接受 6 周 GPACTS，另一组接受 6 周 IST。在 6 周干预治疗后，患者将随访 12 个月。两组的随访相同，包括基线时和治疗结束后 10 天内以及结束 GPACTS/IST 治疗后 3、6 和 12 个月时进行问卷调查。
据我们所知，这是法国首次进行此类随机对照试验，到目前为止，文献中尚无关于团体心理治疗治疗自杀未遂者的研究。研究结果将为专业人员提供明确的指导，以便对有自杀企图的人应用心理干预。该方案符合伦理原则，并已获得当地伦理委员会的批准。结果将通过在同行评议的论文中发表原创研究、认知治疗治疗师手册和研究会议上的报告进行传播。
ClinicalTrials.gov NCT02664701。于 2017 年 1 月 27 日注册。
