Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2025-12-26 @ 6:38 PM
Study NCT ID:
NCT04072666
Status:
UNKNOWN
Last Update Posted:
2019-08-28
First Post:
2019-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Brief Cognitive Behavioural Therapy (CBT) and the Attempted Suicide Short Intervention Program
Sponsor:
Gold Coast Hospital and Health Service
Organization:
Study Overview
Official Title:
Investigations of Psychological Interventions in Suicide Prevention: A Comparison of Brief Cognitive Behavioural Therapy and the Attempted Suicide Short Intervention Program
Status:
UNKNOWN
Status Verified Date:
2019-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASSIP
Brief Summary:
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.
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.
Detailed Description:
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.
Cost-benefit measures are assessed for both interventions.
All consumers who attempt suicide during the trial period, and are 16 years of age and older, will be offered the opportunity to join the trial. Specific demographic questions will identify the numbers of people who fall within specific target groups to enable a determination regarding any differences in the results being statistically significant.
A consumer/carer representative will participate on the research team, to inform the research and ensure sensitivity to the experiences of consumers with lived experience.
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.
Cost-benefit measures are assessed for both interventions.
All consumers who attempt suicide during the trial period, and are 16 years of age and older, will be offered the opportunity to join the trial. Specific demographic questions will identify the numbers of people who fall within specific target groups to enable a determination regarding any differences in the results being statistically significant.
A consumer/carer representative will participate on the research team, to inform the research and ensure sensitivity to the experiences of consumers with lived experience.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: