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A Comparison of Brief Cognitive Behavioural Therapy (CBT) and the Attempted Suicide Short Intervention Program (ASSIP)

G

Gold Coast Hospital and Health Service

Status

Unknown

Conditions

Suicide, Attempted

Treatments

Behavioral: Suicide Prevention Pathway (SPP)
Behavioral: Attempted Suicide Short Intervention Program (ASSIP)
Behavioral: Cognitive Behavioural Therapy (CBT)

Study type

Interventional

Funder types

Other

Identifiers

NCT04072666
APP1164644

Details and patient eligibility

About

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.

Full 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.

Enrollment

411 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

411 participants in 3 patient groups

ASSIP plus SPP
Experimental group
Description:
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.
Treatment:
Behavioral: Suicide Prevention Pathway (SPP)
Behavioral: Attempted Suicide Short Intervention Program (ASSIP)
CBT plus SPP
Experimental group
Description:
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.
Treatment:
Behavioral: Suicide Prevention Pathway (SPP)
Behavioral: Cognitive Behavioural Therapy (CBT)
SPP alone
Active Comparator group
Description:
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).
Treatment:
Behavioral: Suicide Prevention Pathway (SPP)

Trial contacts and locations

1

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Central trial contact

Chris Stapelberg, MD

Data sourced from clinicaltrials.gov

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