Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04072666


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT04072666
Ethics application status
Date submitted
8/08/2019
Date registered
28/08/2019
Date last updated
28/08/2019

Titles & IDs
Public title
A Comparison of Brief Cognitive Behavioural Therapy (CBT) and the Attempted Suicide Short Intervention Program
Scientific title
Investigations of Psychological Interventions in Suicide Prevention: A Comparison of Brief Cognitive Behavioural Therapy and the Attempted Suicide Short Intervention Program
Secondary ID [1] 0 0
APP1164644
Universal Trial Number (UTN)
Trial acronym
ASSIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide, Attempted 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Attempted Suicide Short Intervention Program (ASSIP)
Behaviour - Cognitive Behavioural Therapy (CBT)
Behaviour - Suicide Prevention Pathway (SPP)

Experimental: ASSIP plus 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.

Experimental: CBT plus 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.

Active Comparator: SPP alone - 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).


Behaviour: 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).

Behaviour: 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.

Behaviour: 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.
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Re-presentation to hospital with suicide attempt and/or suicidal ideations
Timepoint [1] 0 0
7 days post intervention
Primary outcome [2] 0 0
Re-presentation to hospital with suicide attempt and/or suicidal ideations
Timepoint [2] 0 0
14 days post intervention
Primary outcome [3] 0 0
Re-presentation to hospital with suicide attempt and/or suicidal ideations
Timepoint [3] 0 0
30 days post intervention
Primary outcome [4] 0 0
Re-presentation to hospital with suicide attempt and/or suicidal ideations
Timepoint [4] 0 0
90 days post intervention
Primary outcome [5] 0 0
Death by suicide rates
Timepoint [5] 0 0
24 months post intervention
Secondary outcome [1] 0 0
Columbia Suicide Severity Rating Scale (C-SSRS)
Timepoint [1] 0 0
Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
Secondary outcome [2] 0 0
Depression, Anxiety and Stress Scale (DASS)
Timepoint [2] 0 0
Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
Secondary outcome [3] 0 0
The Coping Inventory for Stressful Situations (CISS)
Timepoint [3] 0 0
Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
Secondary outcome [4] 0 0
Resilience Scale for Adults (RSA)
Timepoint [4] 0 0
Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
Secondary outcome [5] 0 0
Resilience Scale for Adolescents (READ)
Timepoint [5] 0 0
Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
Secondary outcome [6] 0 0
The revised Helping Alliance Questionnaire - II (HAqII)
Timepoint [6] 0 0
Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
Secondary outcome [7] 0 0
Independent-Interdependent Problem solving scale (IIPSS)
Timepoint [7] 0 0
Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
411
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Gold Coast Hospital Health - Gold Coast
Recruitment postcode(s) [1] 0 0
4215 - Gold Coast

Funding & Sponsors
Primary sponsor type
Other
Name
Gold Coast Hospital and Health Service
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Bond University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04072666
Trial related presentations / 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Bryan CJ, Wood DS, May A, Peterson AL, Wertenberger E, Rudd MD. Mechanisms of Action Contributing to Reductions in Suicide Attempts Following Brief Cognitive Behavioral Therapy for Military Personnel: A Test of the Interpersonal-Psychological Theory of Suicide. Arch Suicide Res. 2018 Apr-Jun;22(2):241-253. doi: 10.1080/13811118.2017.1319313. Epub 2017 Jun 1.
Stanley B, Brown G, Brent DA, Wells K, Poling K, Curry J, Kennard BD, Wagner A, Cwik MF, Klomek AB, Goldstein T, Vitiello B, Barnett S, Daniel S, Hughes J. Cognitive-behavioral therapy for suicide prevention (CBT-SP): treatment model, feasibility, and acceptability. J Am Acad Child Adolesc Psychiatry. 2009 Oct;48(10):1005-1013. doi: 10.1097/CHI.0b013e3181b5dbfe.
Shea SC. The chronological assessment of suicide events: a practical interviewing strategy for the elicitation of suicidal ideation. J Clin Psychiatry. 1998;59 Suppl 20:58-72.
Public notes

Contacts
Principal investigator
Name 0 0
Chris Stapelberg, MD
Address 0 0
Gold Coast Health and Bond University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Chris Stapelberg, MD
Address 0 0
Country 0 0
Phone 0 0
0405015430
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04072666

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13
Gold Coast University Hospital
Recruitment postcode(s) [1] 18
4215
Funding & Sponsors
Funding source category [1] 8
Charities/Societies/Foundations
Name [1] 8
Suicide Prevention Australia
Address [1] 8
Level 21, 320 Pitt Street, Sydney, NSW
Country [1] 8
Australia
Primary sponsor
Government body
Primary sponsor name
Gold Coast Health
Primary sponsor address
1 Hospital Boulevard, Southport, QLD, 4215
Primary sponsor country
Australia
Secondary sponsor category [1] 9
University
Name [1] 9
Bond University
Address [1] 9
14 University Drive, Robina, QLD, 4226
Country [1] 9
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 11
Human Research Ethics Committee
Address [1] 11
1 Hospital Boulevard, Southport, QLD, 4215
Country [1] 11
Australia
Date submitted for ethics approval [1] 11
27/03/2019
Approval date [1] 11
22/05/2019
Ethics approval number [1] 11
HREC/2019/QGC/51361
 
Public notes

Contacts
Principal investigator
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Address 101 0
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Phone 101 0
Fax 101 0
Email 101 0
Contact person for public queries
Title 102 0
Name 102 0
Address 102 0
Country 102 0
Phone 102 0
Fax 102 0
Email 102 0
Contact person for scientific queries
Title 103 0
Name 103 0
Address 103 0
Country 103 0
Phone 103 0
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Email 103 0