跳至主要内容
临床试验/NCT04072666
NCT04072666Unknown不适用

Investigations of Psychological Interventions in Suicide Prevention: A Comparison of Brief Cognitive Behavioural Therapy and the Attempted Suicide Short Intervention Program

Gold Coast Hospital and Health Service1 个研究点 分布在 1 个国家目标入组 411 人开始时间: 2019年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
411
试验地点
1
主要终点
Re-presentation to hospital with suicide attempt and/or suicidal ideations

研究概览

简要总结

The aim of this project is to assess if adding one of two structured suicide specific psychological interventions to a standardised clinical care approach improves outcomes for consumers presenting to a Mental Health Service with a suicide attempt.

The standardised care approach involves a Suicide Prevention Pathway (SPP) modelled on the Zero Suicide Framework.

The Attempted Suicide Short Intervention Program (ASSIP) is a manualised therapy composed of three therapy sessions following a suicide attempt, with subsequent follow up over two years with personalised mailed letters. Cognitive Behavioural Therapy (CBT)-Based Psychoeducational Intervention is a manualised approach involving brief CBT for suicide in five 60 minute sessions. The intervention incorporates skills development and emphasises internal self-management.

We will compare outcomes for:

  1. The Attempted Suicide Short Intervention Program (ASSIP) + SPP, versus SPP alone
  2. Five Sessions of Cognitive Behavioural Therapy (CBT) + SPP, versus SPP alone
  3. CBT + SPP versus ASSIP + SPP.

Hypotheses:

  1. The use of suicide specific psychological interventions (ASSIP; CBT) combined with a comprehensive clinical suicide prevention pathway (SPP) will have better outcomes than the clinical suicide prevention pathway alone.
  2. Outcomes for the ASSIP + SPP and CBT + SPP will significantly differ.
  3. Cost-benefit analyses will significantly differ between ASSIP and CBT.

详细描述

Key literature: Treatment approaches for suicide: The efficacy of various suicide prevention interventions has been the subject of research for some time, and includes a number of recent systematic reviews (e.g. Zalsman et al., 2016), and Gould, Greenberg, Velting, and Shaffer (2003) reviewed suicide prevention strategies specifically used with young people. Current national suicide prevention programs have highlighted the knowledge that suicide is a behaviour that stems from a complex and multifaceted set of circumstances and individual characteristics. These factors can be present across the human lifespan and occur across multiple cultural and community settings. The complex heterogeneous nature of the factors influencing suicide rates requires a collaborative and coordinated systems approach, incorporating strategies simultaneously implemented across multiple levels, including service systems, individualised interventions and community prevention. Despite this recognition, there remains a significant gap in the evidence base regarding the most effective interventions for use with suicide at the hospital service level.

In 2015, the Gold Coast Mental Heath and Specialist Services (GCMHSS) undertook a review of frameworks for suicide prevention to guide planning and choice of interventions, as well as enhancing the capability of the service and staff to provide interventions aimed at addressing the needs of people presenting as a result of a suicide attempt. Interventions were sought with available evidence of efficacy, based on outcomes obtained in clinical, controlled trials (particularly those suitable for the top six diagnostic related groups for mental health presenting to the Gold Coast Hospital Health Service (GCHHS), with the aim to provide recommendations for service wide implementation. The top six high priority mental health diagnostic groups included: schizophrenia & related disorders, mood/affective disorders, alcohol & substance related disorders, personality disorders, suicidal behaviours, and stress/adjustment/situational crisis. Two of the interventions that demonstrated the strongest quality of evidence included the Attempted Suicide Short Intervention Program (ASSIP) and Cognitive Behavioural Therapy (CBT) based psychological intervention.

This is a randomised controlled trial, with blinding of those assessing the outcomes.

Primary outcome measures: Representation to hospital with suicide attempt and/or suicidal ideations within 7, 14, 30 and 90 days post intervention. Death by suicide rates will also be examined. Death clearly assessed as not involving self-harm will be represented as not completing the study.

Secondary outcome measures: Self-reported level of suicidality, depression, anxiety, stress, resilience, problem solving skills and self- and therapist-reported level of therapeutic engagement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Given the clear differences in interventions, participants and those administering the interventions will not be blinded. However, those analysing data and assessing the outcomes will be blinded to group assignment.

入排标准

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

入选标准

  • •Consumers aged 16 years and above residing in the Gold Coast catchment area
  • •Presenting to the Gold Coast Hospital with a recent suicide attempt and then placed on the Suicide Prevention Pathway.

排除标准

  • •Refusal of, or inability to, consent
  • •People who are already receiving specialised psychological interventions (such as CBT) will be excluded due to the potential confounding effect, but not people taking psychotropic medication

研究组 & 干预措施

ASSIP plus SPP

Experimental

Participants in the ASSIP group will receive a combination of the comprehensive clinical SPP (i.e. standardised assessment, risk evaluation and formulation, safety planning and follow-up), and the ASSIP psychological intervention where they will receive three therapy sessions followed by regular ongoing contact through individually focused letters sent over 24 months.

干预措施: Attempted Suicide Short Intervention Program (ASSIP) (Behavioral)

ASSIP plus SPP

Experimental

Participants in the ASSIP group will receive a combination of the comprehensive clinical SPP (i.e. standardised assessment, risk evaluation and formulation, safety planning and follow-up), and the ASSIP psychological intervention where they will receive three therapy sessions followed by regular ongoing contact through individually focused letters sent over 24 months.

干预措施: Suicide Prevention Pathway (SPP) (Behavioral)

CBT plus SPP

Experimental

Participants in the CBT group will receive a combination of the comprehensive clinical SPP (i.e. standardised assessment, risk evaluation and formulation, safety planning and follow-up), and the CBT psychological intervention where they will receive five CBT 60-minute individual sessions.

干预措施: Cognitive Behavioural Therapy (CBT) (Behavioral)

CBT plus SPP

Experimental

Participants in the CBT group will receive a combination of the comprehensive clinical SPP (i.e. standardised assessment, risk evaluation and formulation, safety planning and follow-up), and the CBT psychological intervention where they will receive five CBT 60-minute individual sessions.

干预措施: Suicide Prevention Pathway (SPP) (Behavioral)

SPP alone

Active Comparator

The Suicide Prevention Pathway (SPP) comprises seven steps:

i) Initial screening - persons experiencing suicide ideation and who may also have a history of, or recent, suicide attempt, are placed on the pathway; ii) Assessment of suicide risk iii) Formulation of suicide risk (based on a prevention oriented approach) iv) Safety planning (collaboratively developed with the client) and Counselling on access to lethal means v) Structured follow-up (within 24-48 hrs); vi) Transition of care plan; and vii) Caring contacts - ongoing contact/support for the person for the next 2 years (through personalised letters or phone texts).

干预措施: Suicide Prevention Pathway (SPP) (Behavioral)

结局指标

主要结局

Re-presentation to hospital with suicide attempt and/or suicidal ideations

时间窗: 90 days post intervention

Re-presentations to hospital emergency department (ED) with suicide attempts and/or suicidal ideations will be examined post intervention

Death by suicide rates

时间窗: 24 months post intervention

Death by suicide rates will also be examined post intervention

Re-presentation to hospital with suicide attempt and/or suicidal ideations

时间窗: 7 days post intervention

Re-presentations to hospital emergency department (ED) with suicide attempts and/or suicidal ideations will be examined post intervention

Re-presentation to hospital with suicide attempt and/or suicidal ideations

时间窗: 14 days post intervention

Re-presentations to hospital emergency department (ED) with suicide attempts and/or suicidal ideations will be examined post intervention

Re-presentation to hospital with suicide attempt and/or suicidal ideations

时间窗: 30 days post intervention

Re-presentations to hospital emergency department (ED) with suicide attempts and/or suicidal ideations will be examined post intervention

次要结局

  • Columbia Suicide Severity Rating Scale (C-SSRS)(Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline)
  • Depression, Anxiety and Stress Scale (DASS)(Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline)
  • The Coping Inventory for Stressful Situations (CISS)(Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline)
  • Resilience Scale for Adults (RSA)(Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline)
  • Resilience Scale for Adolescents (READ)(Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline)
  • The revised Helping Alliance Questionnaire - II (HAqII)(Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline)
  • Independent-Interdependent Problem solving scale (IIPSS)(Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验