跳至主要内容
临床试验/NCT06322199
NCT06322199进行中(未招募)不适用

Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy ASSIP on Neuropsychological Correlates and Psychological Process Factors (NePsyASSIP HT) - Project 3

University of Bern4 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2022年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
119
试验地点
4
主要终点
Suicidal ideation (Follow-up, t1)

研究概览

简要总结

The present study consists of 3 projects in total. It aims to investigate the (neuro-) psychological patterns from suicidal ideation to suicidal behavior as well as the feasibility and cost-effectiveness of ASSIP flex.

The overall aim of Project 3 is to evaluate the feasibility and cost-effectiveness of ASSIP flex over a 12-month follow-up period in terms of suicide reattempts and suicide correlates in a cohort who is attending ASSIP flex after a suicide attempt.

详细描述

Purpose and aims:

In project 3, the feasibility and cost-effectiveness of ASSIP flex setting over a 12-month follow-up period will be investigated. To investigate that, the present study examines the newly implemented ASSIP flex service developed and implemented at the University Hospital of Psychiatry and Psychotherapy Bern (Switzerland).

Background:

In Switzerland, approximately three people die by suicide every day, and suicide attempts exceed this number by far. As a previous suicide attempt is one of the strongest predictors of a completed suicide, it is of utmost importance to identify the people at risk. However, research has shown that traditional risk factors (e.g., depression, psychiatric disorder, etc.) reliably predict suicide ideation but poorly predict suicidal behavior. Furthermore, while effective suicide-specific interventions exist, up to 50% of the suicide attempters reject the recommended treatment, and around 60% discontinue treatment after one session. Hence, a different approach is required. In this study, three projects will be conducted. Project 3 evaluates the feasibility and cost-effectiveness of ASSIP flex.

Study design of Project 3:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects fulfilling the following inclusion criteria are eligible for the study:
  • Informed consent as documented by signature
  • Age ≥ 18 years
  • At least one previous suicide attempt
  • Willingness to attend the ASSIP Flex

排除标准

  • The presence of any one of the following exclusion criteria will lead to exclusion of the subject:
  • Serious cognitive impairment
  • Any psychotic disorder
  • Inability to follow the procedures of the study (e.g., insufficient mastery of the German language, previous enrolment into the current study)

结局指标

主要结局

Suicidal ideation (Follow-up, t1)

时间窗: After the three ASSIP flex sessions are completed, up to 4-6 weeks.

The Beck Scale for Suicide Ideation (BSI) is a clinical assessment tool designed to measure the severity of suicidal ideation in individuals. It is used in clinical and research settings to assess the risk of suicide. The BSI consists of 19 items, and each item is scored on a 3-point scale (0 to 2). The total score, which ranges from 0 to 38, reflects the severity of suicidal ideation. The minimum score is 0, indicating no suicidal ideation and the maximum score is 38, indicating the highest level of suicidal ideation. Higher scores indicate a greater severity of suicidal ideation, and thus, higher scores are generally associated with a worse outcome.

Suicidal ideation and suicidal behavior (Baseline, t0)

时间窗: One week before the first ASSIP flex session.

The Suicidal Ideation and Behavior Scale (SSEV) is a German 9-item self-report instrument. Items 1-7 assess the frequency of suicidal ideation, suicidal intention, suicidal impulses, and suicide plan (0 = never to 5 = many times every day). A total value is calculated using items 1-7, where a value of 0-30 can result. Additionally, suicide attempts during the past four weeks and the occurrence of lifetime suicide attempts are assessed with a dichotomous response format (yes/ no) and it is asked about the frequency of lifetime suicide attempts. Higher scores indicate a more severe level of suicidal ideation, which is generally associated with a worse outcome.

Suicidal ideation and suicidal behavior (Follow-up, t1)

时间窗: After the three ASSIP flex sessions are completed, up to 4-6 weeks.

The Suicidal Ideation and Behavior Scale (SSEV) is a German 9-item self-report instrument. Items 1-7 assess the frequency of suicidal ideation, suicidal intention, suicidal impulses, and suicide plan (0 = never to 5 = many times every day). A total value is calculated using items 1-7, where a value of 0-30 can result. Additionally, suicide attempts during the past four weeks and the occurrence of lifetime suicide attempts are assessed with a dichotomous response format (yes/ no) and it is asked about the frequency of lifetime suicide attempts. Higher scores indicate a more severe level of suicidal ideation, which is generally associated with a worse outcome.

Suicidal ideation (Baseline, t0)

时间窗: One week before the first ASSIP flex session.

The Beck Scale for Suicide Ideation (BSI) is a clinical assessment tool designed to measure the severity of suicidal ideation in individuals. It is used in clinical and research settings to assess the risk of suicide. The BSI consists of 19 items, and each item is scored on a 3-point scale (0 to 2). The total score, which ranges from 0 to 38, reflects the severity of suicidal ideation. The minimum score is 0, indicating no suicidal ideation and the maximum score is 38, indicating the highest level of suicidal ideation. Higher scores indicate a greater severity of suicidal ideation, and thus, higher scores are generally associated with a worse outcome.

Suicidal ideation and suicidal behavior (Follow-up, t2)

时间窗: 12 months after the baseline assessment.

The Suicidal Ideation and Behavior Scale (SSEV) is a German 9-item self-report instrument. Items 1-7 assess the frequency of suicidal ideation, suicidal intention, suicidal impulses, and suicide plan (0 = never to 5 = many times every day). A total value is calculated using items 1-7, where a value of 0-30 can result. Additionally, suicide attempts during the past four weeks and the occurrence of lifetime suicide attempts are assessed with a dichotomous response format (yes/ no) and it is asked about the frequency of lifetime suicide attempts. Higher scores indicate a more severe level of suicidal ideation, which is generally associated with a worse outcome.

Suicidal ideation (Follow-up, t2)

时间窗: 12 months after the baseline assessment.

The Beck Scale for Suicide Ideation (BSI) is a clinical assessment tool designed to measure the severity of suicidal ideation in individuals. It is used in clinical and research settings to assess the risk of suicide. The BSI consists of 19 items, and each item is scored on a 3-point scale (0 to 2). The total score, which ranges from 0 to 38, reflects the severity of suicidal ideation. The minimum score is 0, indicating no suicidal ideation and the maximum score is 38, indicating the highest level of suicidal ideation. Higher scores indicate a greater severity of suicidal ideation, and thus, higher scores are generally associated with a worse outcome.

次要结局

  • Treatment costs of treatments 1(t0) Before the first ASSIP flex session, 1 week after informed consent procedure; t1) After the intervention, 4-6 weeks after t0; t2) up to 12 months after t0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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