Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Suicide, Attempted
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomisation will occur after recruitment. Participants will be randomised to either SPP, SPP alone + ASSIP or SPP + CBT. An intent-to-treat approach will be used and all participants randomly assigned to treatment groups using the ralloc command of Stata, which will employ block randomisation.Masking: Double (Investigator, Outcomes Assessor)Masking Description: 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.Primary Purpose: Prevention

Participation Requirements

Age
Between 16 years and 125 years
Gender
Both males and females

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 suicid...

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.

Tracking Information

NCT #
NCT04072666
Collaborators
Bond University
Investigators
Principal Investigator: Chris Stapelberg, MD Gold Coast Health and Bond University Principal Investigator: Kathryn Turner, MD Gold Coast Health Principal Investigator: Sabine Woerwag-Mehta, MD Gold Coast Health and Bond University Principal Investigator: Sarah Walker, Psy.D Gold Coast Health Principal Investigator: Anthony Pisani, Ph.D University of Rochester Principal Investigator: Konrad Michel, MD Bern University Hospital