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

Study Overview
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Brief Summary
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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: 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
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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.

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

Conditions
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Suicide, Attempted

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASSIP plus SPP<br>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. | Behavioral: Attempted Suicide Short Intervention Program (ASSIP)<br>* 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).<br>Behavioral: Suicide Prevention Pathway (SPP)<br>* 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.<br>|
| Experimental: CBT plus SPP<br>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. | Behavioral: Cognitive Behavioural Therapy (CBT)<br>* 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.<br>Behavioral: Suicide Prevention Pathway (SPP)<br>* 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.<br>|
| Active Comparator: SPP alone<br>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). | Behavioral: Suicide Prevention Pathway (SPP)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Death by suicide rates | Death by suicide rates will also be examined post intervention | 24 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suicide Prevention, Suicide Attempt, Brief Intervention