Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001221842
Ethics application status
Approved
Date submitted
30/11/2020
Date registered
13/09/2021
Date last updated
13/09/2021
Date data sharing statement initially provided
13/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mobile phone access to Psychological Therapies (IAPT-M) for people presenting to the Emergency Department with suicidal behaviour.
Scientific title
Effect of Access to Psychological Therapies enhanced by mobile phone and family engagement referred as (IAPT-M) on Suicidal Ideations: a randomised trial of people presenting to the Emergency Department with suicidal behaviour
Secondary ID [1] 302847 0
None
Universal Trial Number (UTN)
U1111-1261-6500
Trial acronym
IAPT-M
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide Prevention 319827 0
Condition category
Condition code
Mental Health 317767 317767 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 319131 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325789 0

Suicide ideation assessed using qu 9 of PHQ-9 (0-3)
Timepoint [1] 325789 0
PHQ9 - qu 9 will be administered at baseline, each participant session, (which should include 3 months), 6 months and 10 months. The primary timepoint is 10 months.
Primary outcome [2] 328336 0
Patient Safety Screen (PSS) - number of suicide attempts in the last 2 weeks
Timepoint [2] 328336 0
baseline, 3, 6 and 10 months. The primary timepoint is 10 months
Secondary outcome [1] 389140 0
Depression severity (PHQ-9);
Timepoint [1] 389140 0
baseline, each IAPT attendance, 3, 6, 10 months post- baseline
Secondary outcome [2] 398632 0
Anxiety severity GAD-7
Timepoint [2] 398632 0
baseline, each IAPT-M attendance, 3, 6 and 10 months post baseline
Secondary outcome [3] 398633 0
Severity of disability and handicap : Work and Social Adjustment scale (WASA)
Timepoint [3] 398633 0
baseline, 3 month, 6 month and 10 month post baseline
Secondary outcome [4] 398634 0
Self-hatred: Self-Hate scale
Timepoint [4] 398634 0
baseline, 3, 6 and 10 month post baseline
Secondary outcome [5] 398635 0
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.
Timepoint [5] 398635 0
between 6 and 10 months post baseline for each selected participant and SO

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For this pilot trial the analysis will be using descriptive statistics, including frequency, means and standard deviation for questionnaire scores at baseline, 3, 6 and 10 months for the 10-15 individual participants. Whilst the primary outcomes of suicidal ideation and suicide attempts will be recorded at these time points there will not be sufficient data to make conclusions of significance between time points however the range of scores and trends will potentially inform sample size calculations for a larger randomised trial.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/06/2021
Date of last participant enrolment
Anticipated
1/10/2021
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
15
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 18108 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 18109 0
Noarlunga Health Service - Noarlunga Centre
Recruitment postcode(s) [1] 32099 0
5042 - Bedford Park
Recruitment postcode(s) [2] 32100 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 307268 0
University
Name [1] 307268 0
Flinders University
Country [1] 307268 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Road
BEDFORD PARK SA 5042
Country
Australia
Secondary sponsor category [1] 307965 0
None
Name [1] 307965 0
Address [1] 307965 0
Country [1] 307965 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307365 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 307365 0
Ethics committee country [1] 307365 0
Australia
Date submitted for ethics approval [1] 307365 0
23/11/2020
Approval date [1] 307365 0
05/01/2021
Ethics approval number [1] 307365 0
HREC/20/SAC/301.20

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106974 0
Prof Malcolm Battersby
Address 106974 0
Flinders University
Sturt Road
BEDFORD PARK SA 5042
Country 106974 0
Australia
Phone 106974 0
+61 08 8404 2314
Fax 106974 0
Email 106974 0
[email protected]
Contact person for public queries
Name 106975 0
Malcolm Battersby
Address 106975 0
Flinders University
Sturt Road
BEDFORD PARK SA 5042
Country 106975 0
Australia
Phone 106975 0
+61 08 8404 2314
Fax 106975 0
Email 106975 0
[email protected]
Contact person for scientific queries
Name 106976 0
Malcolm Battersby
Address 106976 0
Flinders University
Sturt Road
BEDFORD PARK SA 5042
Country 106976 0
Australia
Phone 106976 0
+61 08 8404 2314
Fax 106976 0
Email 106976 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
This is a pilot clinical trial study and hence the treatment given to the participants is
technically experimental (though an adjunct to standard IAPT), and results will not be provided specifically to the participants. Shared data will only be the individual participant de-identified data of published results.
When will data be available (start and end dates)?
Beginning 3 months after publication with no end date determined
Available to whom?
to researchers and clinicians who provide a sound methodological proposal and at the discretion of the main sponsor
Available for what types of analyses?
Only to achieve the aims of the approved proposal
How or where can data be obtained?
subject to approval, from the principal investigator Prof Malcolm Battersby [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.