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

Suicide, Attempted Clinical Trial

— ASSIP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04072666
• Other study ID #: APP1164644
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2019
• Source: Gold Coast Hospital and Health Service
• Contact: Chris Stapelberg, MD
• Phone: 0405015430
• Email: chris.stapelberg[@]health.qld.gov.au
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 411
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suicide
• Suicide, Attempted

Intervention

Behavioral:
• 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).
• 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.
• 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.

Locations

Country	Name	City	State
Australia	Gold Coast Hospital Health	Gold Coast	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
Gold Coast Hospital and Health Service	Bond University

Country where clinical trial is conducted

Australia, 

References & Publications (18)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Fleischmann A, Bertolote JM, Wasserman D, De Leo D, Bolhari J, Botega NJ, De Silva D, Phillips M, Vijayakumar L, Värnik 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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). pii: E243. doi: 10.3390/ijerph14030243. — View Citation

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. — View Citation

Sánchez 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. — View Citation

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. Review. — View Citation

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):1005-13. doi: 10.1097/CHI.0b013e3181b5dbfe. — View Citation

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. — View Citation

Zalsman G, Hawton K, Wasserman D, van Heeringen K, Arensman E, Sarchiapone M, Carli V, Höschl C, Barzilay R, Balazs J, Purebl G, Kahn JP, Sáiz 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. Review. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 days post intervention
Primary	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	14 days post intervention
Primary	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	30 days post intervention
Primary	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	90 days post intervention
Primary	Death by suicide rates	Death by suicide rates will also be examined post intervention	24 months post intervention
Secondary	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.	Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
Secondary	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.	Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
Secondary	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.	Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
Secondary	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).	Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
Secondary	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).	Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
Secondary	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.	Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline
Secondary	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.	Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline

External Links

•   Zero Suicide Strategy