A Randomized Clinical Study of "Attempted Suicide Short Intervention Program" in Swedish Healthcare - ASSIP
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 460
- 试验地点
- 4
- 主要终点
- Number of suicide attempts up to 3 months after inclusion
研究概览
简要总结
This is a randomized study of ASSIP as a treatment for patients who have recently made a suicide attempt. Six psychiatric clinics from four regions in Sweden are included. Together 460 patients will be recruited. Patients will be randomized to ASSIP as a supplement to treatment as usual or to treatment as usual only.
The overall aim of the study is to evaluate whether ASSIP, a short-term clinical intervention, can prevent future suicidal behavior in people who have attempted suicide better than just conventional treatment. The project also investigates whether there are any specific factors that may be related to ASSIP's potential effectiveness and whether ASSIP has health economic benefits.
Only patients who give their written consent will be included in the study. Those who meet the inclusion and no exclusion criteria at screening / visit 1 undergo an assessment according to an interview protocol, self-assessment form, and self-assessment scales. Thereafter, the patient is randomized via an electronic system to either ASSIP plus standard treatment or only standard treatment. All patients, regardless of which treatment they are randomized to, will be followed up for two years with a telephone interview and self-assessment scales month 3, 12 and 24. Data from medical records and registers will also be collected.
详细描述
Purpose and aims:
The overall purpose of this project is to evaluate ASSIP for the prevention of future suicidal behavior in persons who attempt suicide. The specific goals are a) to examine the effectiveness of Attempted Suicide Short Intervention Program (ASSIP) in reducing new suicide attempts in Swedish healthcare, b) to identify factors associated with the effectiveness of ASSIP, c) to construct a cost-effectiveness model of ASSIP.
Background:
According to a consensus position paper from the evidence-based national suicide prevention task force in Europe, health care approaches with high evidence include treatment of depression and ensuring chain of care. These strategies are in line with Swedish guidelines. However, several recent international studies suggest that interventions specifically targeted to prevent suicide attempts may be more successful and that brief psychological interventions are of interest . One promising brief psychotherapeutic intervention to prevent new suicide attempts in suicide attempters is ASSIP . An RCT from Switzerland that included 120 patients showed an 80% risk reduction for new suicide attempt within two years, when ASSIP was added on to treatment as usual (TAU) compared to TAU alone.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Signed informed consent to participate in the study.
- •Contact with psychiatric health care after a suicide attempt within 3 months before the baseline visit
- •Booked meeting or visit in psychiatry or primary care after visit 1
排除标准
- •Psychotic illness with current delusions, hallucinations or other negative symptoms that may affect the therapy.
- •Known emotionally unstable personality disorder (ICD 10) noted in the medical record
- •Inability to undergo therapy without an interpreter
- •Mental retardation, dementia, or other circumstances that make it difficult to understand the meaning of participating in the study and giving informed consent.
研究组 & 干预措施
ASSIP plus treatment as usual
ASSIP according to manual. Treatment as usual will be multidisciplinary and combine psychotherapy, pharmacotherapy and other treatments as well as referral to specialist psychiatry or primary care as required.
干预措施: ASSIP + treatment as usual (Behavioral)
ASSIP plus treatment as usual
ASSIP according to manual. Treatment as usual will be multidisciplinary and combine psychotherapy, pharmacotherapy and other treatments as well as referral to specialist psychiatry or primary care as required.
干预措施: Treatment as usual and patient safety (Other)
Treatment as usual
Treatment as usual will be multidisciplinary and combine psychotherapy, pharmacotherapy and other treatments as well as referral to specialist psychiatry or primary care as required.
干预措施: Treatment as usual and patient safety (Other)
结局指标
主要结局
Number of suicide attempts up to 3 months after inclusion
时间窗: 3 months after inclusion in study
Telephone follow up at 3 months after inclusion. Medical records data. Register data.
Incremental Cost-Effectiveness Ratio( ICER).
时间窗: 24 months after inclusion
RCT outcomes put into perspective using a health-economic model with a life-time horizon, evidence from literature and complementary register data.
Number of suicide attempts up to 24 months after inclusion
时间窗: 24 months after inclusion in study
Repeated telephone follow up at 3, 12 and 24 months after inclusion. Medical records data. Register data
Number of suicide attempts up to 12 months after inclusion
时间窗: 12 months after inclusion in study
Repeated telephone follow up at 3, 12 after inclusion. Medical records data. Register data.
次要结局
- Changes in Quality of life(24 months)
- Number of suicidal thoughts/plans within 3 months after inclusion(3 months after inclusion in study)
- Periods of employment, unemployment, education, military service or pension(24 months)
- Number of days with sickness and disability benefits(24 months)
- Health care contacts and treatments(24 months after inclusion)
- Number of suicidal thoughts/plans within 24 months after inclusion(24 months after inclusion in study)
- Number of suicidal thoughts/plans within 12 months after inclusion(12 months after inclusion in study)
- Amount of income from employment, social insurance, student aid, pension and unemployment benefits.(24 months)
- Changes in Quality of life(3 months)
- Changes in Quality of life(12 months)