Clinical trial NCT04072666: A Comparison of Brief Cognitive Behavioural Therapy (CBT) and the Attempted Suicide Short Intervention Program
Official title: Investigations of Psychological Interventions in Suicide Prevention: A Comparison of Brief Cognitive Behavioural Therapy and the Attempted Suicide Short Intervention Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suicide, Attempted
Keywords: Suicide Prevention
Suicide Attempt
Brief Intervention
Lead sponsor: Gold Coast Hospital and Health Service
Sponsor class: OTHER_GOV
Collaborators: name: Bond University
First posted: 2019-08-28
Enrollment: 411
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Re-presentation to hospital with suicide attempt and/or suicidal ideations
timeFrame: 7 days post intervention
measure: Re-presentation to hospital with suicide attempt and/or suicidal ideations
timeFrame: 14 days post intervention
measure: Re-presentation to hospital with suicide attempt and/or suicidal ideations
timeFrame: 30 days post intervention
measure: Re-presentation to hospital with suicide attempt and/or suicidal ideations
timeFrame: 90 days post intervention
measure: Death by suicide rates
timeFrame: 24 months post intervention
Secondary outcomes:
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
measure: Depression, Anxiety and Stress Scale (DASS)
timeFrame: Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
measure: The Coping Inventory for Stressful Situations (CISS)
timeFrame: Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
measure: Resilience Scale for Adults (RSA)
timeFrame: Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
measure: Resilience Scale for Adolescents (READ)
timeFrame: Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
measure: The revised Helping Alliance Questionnaire - II (HAqII)
timeFrame: Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
measure: Independent-Interdependent Problem solving scale (IIPSS)
timeFrame: Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
Other outcomes:
Locations:
city: Gold Coast
country: Australia
facility: Gold Coast Hospital Health
state: Queensland
Study officials:
affiliation: Gold Coast Health and Bond University
name: Chris Stapelberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gold Coast Health
name: Kathryn Turner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gold Coast Health and Bond University
name: Sabine Woerwag-Mehta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gold Coast Health
name: Sarah Walker, Psy.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Anthony Pisani, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Bern University Hospital
name: Konrad Michel, MD
role: PRINCIPAL_INVESTIGATOR
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