None listed
Conditions
Brief summary
This 12-month pilot trial at Southern Adelaide Local Health Network Emergency Departments (EDs) will build upon the successful ED-SAFE trial in the United States which reduced the number of people attempting suicide in the 12 months after discharge from 8 hospital EDs. The interventions included post ED phone counselling and involvement of a family member over a 12 -month period. The Southern Adelaide mental health team have implemented post ED Improving Access to Psychological Therapies (IAPT) phone delivered cognitive behaviour therapy (CBT) at the Flinders Medical Centre, which has resulted in a 59% recovery rate for anxiety and depression. IAPT was also used for the Beyond Blue New Access project with nearly 4000 participants achieving recovery from anxiety and depression of 68% with no suicides . Surprisingly few trials of suicide prevention have included a family member. In this pilot trial, the intervention (IAPT-M), provided over 6 months will consist of 3 evidence-based modifications to standard IAPT: a) 7 sessions of guided self-help CBT focussing on suicidal ideation and problem solving, b) 4 sessions involving a family member, and c) personalised text messaging and use of Mindtick app to monitor mood and activity In this 12-month study period, 10-15 people with suicide attempts presenting to an Emergency Department will be offered a 6 month intervention (IAPT-M) followed for a study period of 10 months with the primary outcome being suicidal ideation and suicide attempts. This phone delivered service can be scaled up to be provided to any Emergency Department in Australia.
Interventions
This is a phase 1 pilot project of the Improving Access to Psychological Therapies - Mobile (IAPT-M) intervention. This is an open label pilot project aiming to recruit 10-15 participants and their significant other (SO) from two hospital Emergency Departments. The trial will run over 12 months with each participant and SO provided with the intervention for 6 months and final follow up 4 months later (total of 10 months from baseline). The aim is to refine the content and process of the trial and the intervention in preparation for a phase 2 randomised trial. In addition to quantitative pre post data collected from each participant, qualitative data will also be collected from semi-structured phone interviews with participants (5), SOs (5) and clinical and trial staff (4) to determine benefits or negative effects of the intervention and suggestions for improvement. Trained research personnel based in Flinders Medical Centre (FMC) and Noarlunga ED will review the medical notes of all patients assessed for a mental health issue to determine if there is any level of self-harm including self-injury e.g., overdose and laceration, so as to include those who may have attempted suicide or suicidal ideation in the last 2 weeks. The research personnel will then consult with the treating doctor to ensure the patient is medically stable and cooperative enough to be approached for informed consent. After informed consent, the research personnel will conduct an eligibility interview using a Patient Safety Screen (PSS) to limit subjectivity to determine if suicide attempts or ideation have occurred in the last 2 weeks or the current presentation. If the patient remains eligible they will be officially recruited into the trial as a participant, If the patient does not consent for the trial, they will be offered usual care of treatment. All participants and family members will be given information on access to crisis services including the state mental health triage phone number. If at any point during the trial, they or a trial staff member recognise the person is in a crisis they will be advised to attend the nearest ED. The initial baseline assessment will occur by phone or secure telehealth video conferencing. The assessment will be initiated within 48 hours of discharge from the ED or within a maximum of 7 days. The initial session is the first of 7 sessions offered to the participant and includes psychiatric assessment, problem and treatment goals, safety plan and review of the IAPT-M workbook (see below). The Intervention, IAPT-M (three components) 1) The IAPT-M workbook is based on the structure of the CLASP phone-based sessions provided in the ED-SAFE trial in the US (Ivan Miller and colleagues) and personal communication with I Miller, which has values-based content derived from Acceptance and Commitment theory. Up to 7 sessions will be provided for the participant and 4 to the significant other over a 6 month period. These sessions will be provided by trained therapist over the phone approximately 1-2 weeks apart. Each session will be over 30-45 minutes. The frequency of sessions will be negotiated with the participant. The content of IAPT-M includes a safety plan then use of the workbook with a specific focus on suicidal ideation, using life values and goals as an alternative pathway to problem solving crises than suicidal ideation and behaviour. Each of the subsequent sessions focuss on the tasks that the patient has attempted and problem solving. 2) Family member/carer/friend - significant other (SO). At session 2 the therapist discusses with the patient the importance of collaborative monitoring and problem solving with the SO and seeks approval to invite them to session 4. In a joint session 4 the safety/life plan is discussed with the SO and patient. Three subsequent sessions are provided for the SO alone focussing on their perceptions and concerns about the patient, their own welfare, and monitoring and support for problem solving in relation to risk factors. Frequency of the 3 remaining sessions is preferably in the same week as the participant session but will be negotiated with the SO. 3) Mobile phone text messaging. During the first session with the patient the option of receiving text messages tailored to the patient is provided. If acceptable to the patient, text messages will be targeted to therapy goals, monitoring of mood and suicidal thoughts and use of the safety plan. Texts are provided weekly but with frequency tailored based on patient preference. Texts are one way only (patients cannot reply to the text). In addition, the specialised “MindTick” app will be installed in the participant’s mobile phone. This purpose built app provides mood, sleep and activity monitoring. The participant is asked to record these items once daily. These are then discussed with the therapists at the subsequent session. Experience from the ED-SAFE trial demonstrated that some patients did not have a significant other or that either the patient or the significant other were ambivalent about participating or in abusive relationship. Unless the patient is deemed at risk, the SO will be encouraged to participate, and the relationship issue/abuse could become a problem to be addressed. Where the relationship is problematic, another family member could be approached. If there is no SO, a volunteer or community provider could be asked to nominate a SO. If none is available or acceptable to the patient, other aspects of IAPT-M will be provided, and the patient retained in the study. A sub-study will be conducted using qualitative methods ie individual semi-structured interviews of 5 participants, 5 SOs and 4 ED clinicians, 2 trial staff purposefully chosen to include gender balance, engagement or lack of in the intervention, with and without engagement of a significant other, willingness to participate (Participants and SO) and 2 ED nurses 2 doctors with gender balance, using open ended questions that explore benefits or otherwise of the intervention, barriers to accessing or implementation of the intervention, role and expertise of the therapist, and suggestions for improvement. The interview will take between 20-40 minutes and take place by phone or face to face depending on convenience to the participant. first 10 participants, based on participant choice and willingness to participate. Adherence to the intervention will be monitored for the participant through number of sessions attended, use of workbook modules completed, receipt of text messages and and use of the MINDtick app, and for the significant other through number of sessions attended and use of the workbook ie modules completed
Sponsors
Study design
Eligibility
Inclusion criteria
Age greater than equal to 18 years, a suicide attempt defined as ‘a potentially self- injurious behaviour with a nonfatal outcome for which there is evidence, either explicit or implicit, that the individual intended to kill himself or her- self ‘ i.e., including an actual, aborted, or interrupted attempt to kill oneself in the past 2 weeks, able to consent (alert, fully oriented, not intoxicated, understand study requirements), willing to complete telephone follow-up assessments and provide at least 2 verifiable contacts.
Exclusion criteria
Medically or cognitively unable to participate in the assessment or counselling (e.g., altered level of consciousness, chronic severe pain, psychosis, hostile behaviour), currently dwelling in a non-community setting, being admitted to an acute psychiatric unit from ED (Short Stay Unit is included in eligibility), physical rehabilitation, substance abuse treatment, or nursing home, currently in custody or pending legal action, lack of permanent residence, lack of phone access, insurmountable language difficulties.