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临床试验/NCT06263712
NCT06263712招募中不适用

Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy ASSIP on Neuropsychological Correlates and Psychological Process Factors (NePsyASSIP HT) - Project 2

University of Bern2 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2024年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
156
试验地点
2
主要终点
Differences in Inhibitory Control

研究概览

简要总结

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

The overall aim of project 2 is to investigate how the (neuro-) psychological patterns are modulated by the Attempted Suicide Short Intervention Program (ASSIP). Therefore, suicide attempters participating in this project 2 will be randomly assigned to either the intervention group ASSIP or a standard care plus resource interview (STAR) group. The ASSIP and STAR interventions take place at the University Hospital of Psychiatry and Psychotherapy Bern (Switzerland).

At the end of the assessment in project 1 participants who reported a history of past suicide attempt (SUAT) will be informed about project 2.

Only if participants agreed to take part in project 2 and have signed the informed consent, they are randomized into two conditions: The ASSIP intervention (ASSIP) versus standard of care plus resource interview (STAR). Participants of both groups will be assessed again 4 weeks and 12 months after their first baseline assessment of project 1.

详细描述

Purpose and aims:

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

After the cross-sectional study in project 1 determining the (neuro-) psychological patterns between suicide ideators (SUID) and suicide attempters, in project 2, the aim is to learn more about the (neuro-) psychological patterns and how they are modulated by a suicide-specific brief intervention ASSIP that was proven to be effective. In addition to the (neuro-) psychological assessment, longitudinal process factors are examined by comparing an ASSIP intervention group to a group of standard care plus resource interview (STAR). The STAR intervention refers to the usual and customary practices within the field, including suicide risk assessment, a non-specific resource focused intervention and if necessary, further outpatient or inpatient treatment.

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 for 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 1 aims is to identify the (neuro-) psychological patterns of suicidal attempters by comparing between the following four different groups:

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

入选标准

  • for Project 2:
  • 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 brief therapy
  • Owns a smartphone

排除标准

  • for Project 2:
  • The presence of any one of the following exclusion criteria will lead to exclusion of the subject:
  • Serious cognitive impairment
  • Any psychotic disorder
  • Any current medication, which substantially impairs the attention span, reaction, rate or any other relevant cognitive functions
  • 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

Differences in Inhibitory Control

时间窗: The assessment takes place 12 months after the baseline assessment (t2).

The Go/No-Go task is a cognitive task to assess an individual's ability to inhibit a prepotent response. It is used to measure impulse control and response inhibition. The task requires participants to respond ("Go" response) to one type of stimulus and to withhold or inhibit their response ("No-Go" response) to another type of stimulus. The Go/No-Go task yields measures such as reaction time, accuracy, and the ability to inhibit responses. Reaction times can vary widely, and accuracy is often expressed as a percentage of correct responses. Lower reaction times and higher accuracy in withholding responses (No-Go trials) indicate better inhibitory control and cognitive performance.

次要结局

  • Movement analyses(The assessment takes place at all 3 sessions of ASSIP or STAR, up to 1 month.)
  • Selective Attention and Interference Control(The assessment takes place 1 day to 1 week after informed consent (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).)
  • General Sense of Self-Efficacy(The assessment takes place 1 day to 1 week after informed consent (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).)
  • Suicidal ideation(The assessment takes place 1 day to 1 week after informed consent (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).)
  • Locus of control(The assessment takes place 1 day to 1 week after informed consent (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).)
  • Psychological Pain(The assessment takes place 1 day to 1 week after informed consent (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).)
  • Suicidal ideation and behavior(The assessment takes place 1 day to 1 week after informed consent (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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