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

NCT04072666 | Unknown

• 1 other identifier: APP1164644
• Study Type: interventional
• Target: 411
• Locations: 1 country
• Sites: 1

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. 1.The Attempted Suicide Short Intervention Program (ASSIP) + SPP, versus SPP alone
2. 2.Five Sessions of Cognitive Behavioural Therapy (CBT) + SPP, versus SPP alone
3. 3.CBT + SPP versus ASSIP + SPP.
4. 4.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.
5. 5.Outcomes for the ASSIP + SPP and CBT + SPP will significantly differ.
6. 6.Cost-benefit analyses will significantly differ between ASSIP and CBT.

Conditions

Suicide, Attempted

Keywords

Suicide Prevention; Suicide Attempt; Brief Intervention

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Columbia Suicide Severity Rating Scale (C-SSRS)

  Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline

• Depression, Anxiety and Stress Scale (DASS)

  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)

  Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline

• Resilience Scale for Adults (RSA)

  Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline

• Resilience Scale for Adolescents (READ)

  Baseline (pre-intervention); end of intervention (up to 5 weeks); and 6-, 12- and 24 months from baseline

Study Arms (3)

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.

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.

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).

Behavioral: Suicide Prevention Pathway (SPP)

Interventions

Attempted Suicide Short Intervention Program (ASSIP) BEHAVIORAL

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).

ASSIP plus SPP

Cognitive Behavioural Therapy (CBT) BEHAVIORAL

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.

CBT plus SPP

Suicide Prevention Pathway (SPP) BEHAVIORAL

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.

ASSIP plus SPP; CBT plus SPP; SPP alone

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gold Coast Hospital and Health Service: lead
• Bond University: collaborator

Study Sites (1)

Gold Coast Hospital Health

Gold Coast, Queensland, 4215, Australia

Location

Related Publications (20)

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MeSH Terms

Conditions

Suicide, Attempted; Suicide Prevention

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Chris Stapelberg, MD

  Gold Coast Health and Bond University

  PRINCIPAL INVESTIGATOR

• Kathryn Turner, MD

  Gold Coast Health

  PRINCIPAL INVESTIGATOR

• Sabine Woerwag-Mehta, MD

  Gold Coast Health and Bond University

  PRINCIPAL INVESTIGATOR

• Sarah Walker, Psy.D

  Gold Coast Health

  PRINCIPAL INVESTIGATOR

• Anthony Pisani, Ph.D

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Konrad Michel, MD

  Bern University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Stapelberg, MD

CONTACT

0405015430; chris.stapelberg@health.qld.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Given the clear differences in interventions, participants and those administering the interventions will not be blinded. However, those analysing data and assessing the outcomes will be blinded to group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 28, 2019
• Study Start: October 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)