Suicide, AttemptedASSIPNCT04072666

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

A study testing Attempted Suicide Short Intervention Program (ASSIP), Cognitive Behavioural Therapy (CBT) and Suicide Prevention Pathway (SPP) in people with Suicide, Attempted, run by Gold Coast Hospital and Health Service at 1 site in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Suicide, Attempted
What is being tested?: Attempted Suicide Short Intervention Program (ASSIP), Cognitive Behavioural Therapy (CBT) and Suicide Prevention Pathway (SPP)
Type of treatment: Injection or infusion, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 411 participants
Where: 1 siteAustralia
Study dates: 1 Oct 2019to 31 Dec 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

Chris Stapelberg, MD contact

0405015430

chris.stapelberg@health.qld.gov.au

Australia1 site

Gold Coast Hospital Health
Gold Coast, Queensland, 4215
Chris Stapelberg, MD, 0405015430, chris.stapelberg@health.qld.gov.au

Other trials in Australia

About this study

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

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:

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

Hypotheses:

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.
Outcomes for the ASSIP + SPP and CBT + SPP will significantly differ.
Cost-benefit analyses will significantly differ between ASSIP and CBT.

Read the 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.

Conditions: Suicide, Attempted
Being tested: Attempted Suicide Short Intervention Program (ASSIP), Cognitive Behavioural Therapy (CBT), Suicide Prevention Pathway (SPP)
Keywords: Suicide Prevention, Suicide Attempt, Brief Intervention
Medical subject headings: Suicide, Attempted, Suicide Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Attempted Suicide Short Intervention Program (ASSIP)Behavioural
The first session is based on a narrative interview with the consumer relating the personal story of how the point of attempting suicide was reached, videorecorded with consent. The second session involves the therapist and consumer watching the session together to reactivate the consumer's mental state during the crisis in a safe environment. Automatic thoughts, emotions, psychological pain and stress, and contingent behaviour are discussed. A psycho-educative handout is given to consumers. The third session involves discussing the handout. A credit card size leaflet is provided, with long term goals, individual warning signs and safety strategies listed, in addition to a card with crisis phone numbers. The sessions are followed by letters sent over 24 months (Michel, Valach \& Gysin-Maillart, 2017).
Cognitive Behavioural Therapy (CBT)Behavioural
The intervention incorporates skills development and emphasises internal self-management. Therapy focuses on the identification of internal, external and/or thematic triggers for suicidal thinking and behaviours, as well as factors that maintain the desire to suicide, using thought records and/or chain analyses. Therapy aims to challenge distortions and misconceptions, including core beliefs that interfere with the motivation to initiate the process of problem solving and distress tolerance, by working on acceptance of emotional and/or physical pain. The final phase of treatment focuses on relapse prevention. CBT can challenge maladaptive beliefs, improve problem solving skills and social competence.
Suicide Prevention Pathway (SPP)Behavioural
The standardised care approach involves a Suicide Prevention Pathway (SPP) modelled on the Zero Suicide Framework, utilising comprehensive chronological assessment of suicide events (CASE) (Shea, 2009) to elicit suicidal intent, the prevention orientated risk formulation (Pisani, Murrie, \& Silverman, 2016), brief interventions conducted with the consumer during their initial assessment prior to the treatment setting (Stanley et al., 2016), Safety Planning Intervention, Counselling on Access to Lethal Means (CALM), brief patient/carer information, rapid, structured follow up, safe transitions of care and caring contacts (Fleischmann et al., 2008). The SPP is supported by a blended learning course with online and face-to-face training for staff.

Study groups in NCT04072666
Study group	Role	What they receive
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. Receives: Behavioral: Attempted Suicide Short Intervention Program (ASSIP); Behavioral: Suicide Prevention Pathway (SPP)
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. Receives: Behavioral: Cognitive Behavioural Therapy (CBT); Behavioral: Suicide Prevention Pathway (SPP)
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). Receives: Behavioral: Suicide Prevention Pathway (SPP)

What is being measured

The primary outcome is the main question the study is designed to answer.

Re-presentation to hospital with suicide attempt and/or suicidal ideations
Re-presentations to hospital emergency department (ED) with suicide attempts and/or suicidal ideations will be examined post intervention
Measured: 7 days post intervention
Re-presentation to hospital with suicide attempt and/or suicidal ideations
Re-presentations to hospital emergency department (ED) with suicide attempts and/or suicidal ideations will be examined post intervention
Measured: 14 days post intervention
Re-presentation to hospital with suicide attempt and/or suicidal ideations
Re-presentations to hospital emergency department (ED) with suicide attempts and/or suicidal ideations will be examined post intervention
Measured: 30 days post intervention
Re-presentation to hospital with suicide attempt and/or suicidal ideations
Re-presentations to hospital emergency department (ED) with suicide attempts and/or suicidal ideations will be examined post intervention
Measured: 90 days post intervention
Death by suicide rates
Death by suicide rates will also be examined post intervention
Measured: 24 months post intervention

Secondary outcomes (7)

Columbia Suicide Severity Rating Scale (C-SSRS)
The Columbia Suicide Severity Rating Scale (C-SSRS) is a suicide ideation and behaviour rating scale that supports suicide assessment through a series of simple, plain-language questions that anyone can ask. The maximum suicidal ideation category (1-5 on the C-SSRS) present at the assessment. A score of 0 indicates that no suicide ideation is present.
Measured: Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
Depression, Anxiety and Stress Scale (DASS)
The Depression, Anxiety and Stress Scale (DASS) is a set of three self-report scales (21 item version) designed to measure the negative emotional states of depression, anxiety and stress. For this short (21-item) version of the DASS, Stress, Anxiety, and Depression scores a multiplied by 2 to get a score of 42 for each subscale (score 0-42). Higher scores of each subscale indicate higher emotional states of depression, anxiety, or stress.
Measured: 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)
The Coping Inventory for Stressful Situations (CISS) is a 48 item self-report questionnaire for clinical and non-clinical settings. The CISS is a four-factor model of human coping with adversity. The construct differentiates three types of coping: emotion-orientated (7 items), task orientated (7 items), and avoidance (distracted or social; 7 items). Respondents rate each item on a five point scale: (1) Not at all to (5) Very much. Scores range from 7-35 for each subscale (emotion-orientated coping, task-orientated coping, and avoidance coping). Higher scores indicate greater preference for task-orientated, emotion-orientated, or avoidance coping style.
Measured: Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
Resilience Scale for Adults (RSA)
The Resilience Scale for Adults (RSA) is a 33 item self-report measure of resilience for adults. Items are rated on a 7-point scale: (1) Not true at all to (7) Very True. Higher scores indicate greater resilience (range 33 to 231).
Measured: Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
Resilience Scale for Adolescents (READ)
The Resilience Scale for Adolescents (READ) is a 28 item self-report measure of resilience for adolescents. The scale consists of individual, family and external supports conceptual categories, and has been used to screen and profile for intervention. Items are rated on a 5-point scale: (1) Totally disagree (5) Totally agere. Higher scores indicate greater resilience (range 28 to 140).
Measured: 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)
The revised Helping Alliance Questionnaire - II (HAqll) is a 19 item self-report questionnaire used to evaluate the quality of the patient-therapist relationship. Items are rated from (1) Strongly disagree to (6) Strongly agree. Total score ranges from 19 to 114. Higher scores indicate greater therapeutic alliance.
Measured: Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
Independent-Interdependent Problem solving scale (IIPSS)
The Independent-Interdependent Problem solving scale (IIPSS) is a 10-item scale that measures dispositional preferences for independent and interdependent problem-solving. Items are rated from (1) Strongly disagree to (7) Strongly agree. Total score ranges from 10-70. Higher scores indicate greater preference for either independent or interdependent problem-solving style.
Measured: Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201931 Dec 2022

First posted28 Aug 2019
Study start1 Oct 2019 (estimated)
Primary completion31 Dec 2021 (estimated)
Study completion31 Dec 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 411 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04072666
Sponsor's protocol ID: APP1164644
Acronym: ASSIP
Status last verified: Aug 2019
First submitted: 8 Aug 2019
Last updated: 28 Aug 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Pisani AR, Murrie DC, Silverman MM. Reformulating Suicide Risk Formulation: From Prediction to Prevention. Acad Psychiatry. 2016 Aug;40(4):623-9. doi: 10.1007/s40596-015-0434-6. Epub 2015 Dec 14.
PubMed 26667005
Stanley B, Chaudhury SR, Chesin M, Pontoski K, Bush AM, Knox KL, Brown GK. An Emergency Department Intervention and Follow-Up to Reduce Suicide Risk in the VA: Acceptability and Effectiveness. Psychiatr Serv. 2016 Jun 1;67(6):680-3. doi: 10.1176/appi.ps.201500082. Epub 2016 Feb 1.
PubMed 26828397
Bridge JA, Horowitz LM, Campo JV. ED-SAFE-Can Suicide Risk Screening and Brief Intervention Initiated in the Emergency Department Save Lives? JAMA Psychiatry. 2017 Jun 1;74(6):555-556. doi: 10.1001/jamapsychiatry.2017.0677. No abstract available.
PubMed 28456131
Fleischmann A, Bertolote JM, Wasserman D, De Leo D, Bolhari J, Botega NJ, De Silva D, Phillips M, Vijayakumar L, Varnik A, Schlebusch L, Thanh HT. Effectiveness of brief intervention and contact for suicide attempters: a randomized controlled trial in five countries. Bull World Health Organ. 2008 Sep;86(9):703-9. doi: 10.2471/blt.07.046995.
PubMed 18797646
Hassanian-Moghaddam H, Sarjami S, Kolahi AA, Lewin T, Carter G. Postcards in Persia: A Twelve to Twenty-four Month Follow-up of a Randomized Controlled Trial for Hospital-Treated Deliberate Self-Poisoning. Arch Suicide Res. 2017 Jan 2;21(1):138-154. doi: 10.1080/13811118.2015.1004473. Epub 2015 Mar 16.
PubMed 25774646
Gysin-Maillart A, Schwab S, Soravia L, Megert M, Michel K. A Novel Brief Therapy for Patients Who Attempt Suicide: A 24-months Follow-Up Randomized Controlled Study of the Attempted Suicide Short Intervention Program (ASSIP). PLoS Med. 2016 Mar 1;13(3):e1001968. doi: 10.1371/journal.pmed.1001968. eCollection 2016 Mar.
PubMed 26930055
Gysin-Maillart AC, Soravia LM, Gemperli A, Michel K. Suicide Ideation Is Related to Therapeutic Alliance in a Brief Therapy for Attempted Suicide. Arch Suicide Res. 2017 Jan 2;21(1):113-126. doi: 10.1080/13811118.2016.1162242. Epub 2016 Mar 16.
PubMed 26984644
Michel K, Valach L, Gysin-Maillart A. A Novel Therapy for People Who Attempt Suicide and Why We Need New Models of Suicide. Int J Environ Res Public Health. 2017 Mar 1;14(3):243. doi: 10.3390/ijerph14030243.
PubMed 28257071
Mayer KH, Bradford JB, Makadon HJ, Stall R, Goldhammer H, Landers S. Sexual and gender minority health: what we know and what needs to be done. Am J Public Health. 2008 Jun;98(6):989-95. doi: 10.2105/AJPH.2007.127811. Epub 2008 Apr 29.
PubMed 18445789
Sanchez JP, Hailpern S, Lowe C, Calderon Y. Factors associated with emergency department utilization by urban lesbian, gay, and bisexual individuals. J Community Health. 2007 Apr;32(2):149-56. doi: 10.1007/s10900-006-9037-1.
PubMed 17571527
De Leo D, Cerin E, Spathonis K, Burgis S. Lifetime risk of suicide ideation and attempts in an Australian community: prevalence, suicidal process, and help-seeking behaviour. J Affect Disord. 2005 Jun;86(2-3):215-24. doi: 10.1016/j.jad.2005.02.001.
PubMed 15935241
Bennewith O, Evans J, Donovan J, Paramasivan S, Owen-Smith A, Hollingworth W, Davies R, O'Connor S, Hawton K, Kapur N, Gunnell D. A contact-based intervention for people recently discharged from inpatient psychiatric care: a pilot study. Arch Suicide Res. 2014;18(2):131-43. doi: 10.1080/13811118.2013.838196.
PubMed 24673299
Bickley H, Hunt IM, Windfuhr K, Shaw J, Appleby L, Kapur N. Suicide within two weeks of discharge from psychiatric inpatient care: a case-control study. Psychiatr Serv. 2013 Jul 1;64(7):653-9. doi: 10.1176/appi.ps.201200026.
PubMed 23545716
Zalsman G, Hawton K, Wasserman D, van Heeringen K, Arensman E, Sarchiapone M, Carli V, Hoschl C, Barzilay R, Balazs J, Purebl G, Kahn JP, Saiz PA, Lipsicas CB, Bobes J, Cozman D, Hegerl U, Zohar J. Suicide prevention strategies revisited: 10-year systematic review. Lancet Psychiatry. 2016 Jul;3(7):646-59. doi: 10.1016/S2215-0366(16)30030-X. Epub 2016 Jun 8.
PubMed 27289303
Gould MS, Greenberg T, Velting DM, Shaffer D. Youth suicide risk and preventive interventions: a review of the past 10 years. J Am Acad Child Adolesc Psychiatry. 2003 Apr;42(4):386-405. doi: 10.1097/01.CHI.0000046821.95464.CF.
PubMed 12649626

Want to know more?

Chris Stapelberg, MD

0405015430

chris.stapelberg@health.qld.gov.au

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigations of Psychological Interventions in Suicide Prevention: A Comparison of Brief Cognitive Behavioural Therapy and the Attempted Suicide Short Intervention Program
ClinicalTrials.gov ID: NCT04072666
Acronym / sponsor ID: ASSIP / APP1164644
Conditions: Suicide, Attempted
Keywords: Suicide Prevention, Suicide Attempt, Brief Intervention
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 411 participants (estimated)
Lead sponsor: Gold Coast Hospital and Health ServiceOther government
Collaborators: Bond University
Study start: 1 Oct 2019 (estimated)
Primary completion: 31 Dec 2021 (estimated)
Study completion: 31 Dec 2022 (estimated)
First posted: 28 Aug 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

We will compare outcomes for:

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

Hypotheses:

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.
Outcomes for the ASSIP + SPP and CBT + SPP will significantly differ.
Cost-benefit analyses will significantly differ between ASSIP and CBT.

Detailed description

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

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.

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3
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.

Arm	Type	Receives
ASSIP plus SPP	Experimental	Behavioral: Attempted Suicide Short Intervention Program (ASSIP), Behavioral: Suicide Prevention Pathway (SPP)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.
CBT plus SPP	Experimental	Behavioral: Cognitive Behavioural Therapy (CBT), Behavioral: Suicide Prevention Pathway (SPP)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.
SPP alone	Active comparator	Behavioral: Suicide Prevention Pathway (SPP)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).

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Attempted Suicide Short Intervention Program (ASSIP)The first session is based on a narrative interview with the consumer relating the personal story of how the point of attempting suicide was reached, videorecorded with consent. The second session involves the therapist and consumer watching the session together to reactivate the consumer's mental state during the crisis in a safe environment. Automatic thoughts, emotions, psychological pain and stress, and contingent behaviour are discussed. A psycho-educative handout is given to consumers. The third session involves discussing the handout. A credit card size leaflet is provided, with long term goals, individual warning signs and safety strategies listed, in addition to a card with crisis phone numbers. The sessions are followed by letters sent over 24 months (Michel, Valach \& Gysin-Maillart, 2017).	Behavioural	ASSIP plus SPP
Cognitive Behavioural Therapy (CBT)The intervention incorporates skills development and emphasises internal self-management. Therapy focuses on the identification of internal, external and/or thematic triggers for suicidal thinking and behaviours, as well as factors that maintain the desire to suicide, using thought records and/or chain analyses. Therapy aims to challenge distortions and misconceptions, including core beliefs that interfere with the motivation to initiate the process of problem solving and distress tolerance, by working on acceptance of emotional and/or physical pain. The final phase of treatment focuses on relapse prevention. CBT can challenge maladaptive beliefs, improve problem solving skills and social competence.	Behavioural	CBT plus SPP
Suicide Prevention Pathway (SPP)The standardised care approach involves a Suicide Prevention Pathway (SPP) modelled on the Zero Suicide Framework, utilising comprehensive chronological assessment of suicide events (CASE) (Shea, 2009) to elicit suicidal intent, the prevention orientated risk formulation (Pisani, Murrie, \& Silverman, 2016), brief interventions conducted with the consumer during their initial assessment prior to the treatment setting (Stanley et al., 2016), Safety Planning Intervention, Counselling on Access to Lethal Means (CALM), brief patient/carer information, rapid, structured follow up, safe transitions of care and caring contacts (Fleischmann et al., 2008). The SPP is supported by a blended learning course with online and face-to-face training for staff.	Behavioural	ASSIP plus SPP, CBT plus SPP, SPP alone

Primary outcome

Re-presentation to hospital with suicide attempt and/or suicidal ideations
Time frame: 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
Time frame: 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
Time frame: 30 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
Time frame: 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
Time frame: 24 months post intervention
Death by suicide rates will also be examined post intervention

7 secondary outcomes

Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
Depression, Anxiety and Stress Scale (DASS)
Time frame: 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)
Time frame: Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
Resilience Scale for Adults (RSA)
Time frame: Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
Resilience Scale for Adolescents (READ)
Time frame: 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)
Time frame: Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
Independent-Interdependent Problem solving scale (IIPSS)
Time frame: Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
Background: PubMed 26667005Pisani AR, Murrie DC, Silverman MM. Reformulating Suicide Risk Formulation: From Prediction to Prevention. Acad Psychiatry. 2016 Aug;40(4):623-9. doi: 10.1007/s40596-015-0434-6. Epub 2015 Dec 14.
Background: PubMed 26828397Stanley B, Chaudhury SR, Chesin M, Pontoski K, Bush AM, Knox KL, Brown GK. An Emergency Department Intervention and Follow-Up to Reduce Suicide Risk in the VA: Acceptability and Effectiveness. Psychiatr Serv. 2016 Jun 1;67(6):680-3. doi: 10.1176/appi.ps.201500082. Epub 2016 Feb 1.
Background: PubMed 28456131Bridge JA, Horowitz LM, Campo JV. ED-SAFE-Can Suicide Risk Screening and Brief Intervention Initiated in the Emergency Department Save Lives? JAMA Psychiatry. 2017 Jun 1;74(6):555-556. doi: 10.1001/jamapsychiatry.2017.0677. No abstract available.
Background: PubMed 18797646Fleischmann A, Bertolote JM, Wasserman D, De Leo D, Bolhari J, Botega NJ, De Silva D, Phillips M, Vijayakumar L, Varnik A, Schlebusch L, Thanh HT. Effectiveness of brief intervention and contact for suicide attempters: a randomized controlled trial in five countries. Bull World Health Organ. 2008 Sep;86(9):703-9. doi: 10.2471/blt.07.046995.
Background: PubMed 25774646Hassanian-Moghaddam H, Sarjami S, Kolahi AA, Lewin T, Carter G. Postcards in Persia: A Twelve to Twenty-four Month Follow-up of a Randomized Controlled Trial for Hospital-Treated Deliberate Self-Poisoning. Arch Suicide Res. 2017 Jan 2;21(1):138-154. doi: 10.1080/13811118.2015.1004473. Epub 2015 Mar 16.
Background: PubMed 26930055Gysin-Maillart A, Schwab S, Soravia L, Megert M, Michel K. A Novel Brief Therapy for Patients Who Attempt Suicide: A 24-months Follow-Up Randomized Controlled Study of the Attempted Suicide Short Intervention Program (ASSIP). PLoS Med. 2016 Mar 1;13(3):e1001968. doi: 10.1371/journal.pmed.1001968. eCollection 2016 Mar.
Background: PubMed 26984644Gysin-Maillart AC, Soravia LM, Gemperli A, Michel K. Suicide Ideation Is Related to Therapeutic Alliance in a Brief Therapy for Attempted Suicide. Arch Suicide Res. 2017 Jan 2;21(1):113-126. doi: 10.1080/13811118.2016.1162242. Epub 2016 Mar 16.
Background: PubMed 28257071Michel K, Valach L, Gysin-Maillart A. A Novel Therapy for People Who Attempt Suicide and Why We Need New Models of Suicide. Int J Environ Res Public Health. 2017 Mar 1;14(3):243. doi: 10.3390/ijerph14030243.
Background: PubMed 18445789Mayer KH, Bradford JB, Makadon HJ, Stall R, Goldhammer H, Landers S. Sexual and gender minority health: what we know and what needs to be done. Am J Public Health. 2008 Jun;98(6):989-95. doi: 10.2105/AJPH.2007.127811. Epub 2008 Apr 29.
Background: PubMed 17571527Sanchez JP, Hailpern S, Lowe C, Calderon Y. Factors associated with emergency department utilization by urban lesbian, gay, and bisexual individuals. J Community Health. 2007 Apr;32(2):149-56. doi: 10.1007/s10900-006-9037-1.
Background: PubMed 15935241De Leo D, Cerin E, Spathonis K, Burgis S. Lifetime risk of suicide ideation and attempts in an Australian community: prevalence, suicidal process, and help-seeking behaviour. J Affect Disord. 2005 Jun;86(2-3):215-24. doi: 10.1016/j.jad.2005.02.001.
Background: PubMed 24673299Bennewith O, Evans J, Donovan J, Paramasivan S, Owen-Smith A, Hollingworth W, Davies R, O'Connor S, Hawton K, Kapur N, Gunnell D. A contact-based intervention for people recently discharged from inpatient psychiatric care: a pilot study. Arch Suicide Res. 2014;18(2):131-43. doi: 10.1080/13811118.2013.838196.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chris Stapelberg, MD contact

0405015430

chris.stapelberg@health.qld.gov.au

Chris Stapelberg, MD principal investigator

Gold Coast Health and Bond University

Kathryn Turner, MD principal investigator

Gold Coast Health

Sabine Woerwag-Mehta, MD principal investigator

Gold Coast Health and Bond University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chris Stapelberg, MD (0405015430, chris.stapelberg@health.qld.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Re-presentation to hospital with suicide attempt and/or suicidal ideations (time frame: 7 days post intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04072666, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.