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Trial registered on ANZCTR

Registration number

ACTRN12624000941561

Ethics application status

Approved

Date submitted

23/01/2024

Date registered

5/08/2024

Date last updated

5/08/2024

Date data sharing statement initially provided

5/08/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

Feasibility and acceptability of Collaborative Assessment and Management of Suicidality (CAMS) in an Australian inpatient setting

Scientific title

Feasibility and acceptability of Collaborative Assessment and Management of Suicidality (CAMS) in an Australian inpatient setting

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

suicidality

Condition category

Condition code

Mental Health

Suicide

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The Collaborative Assessment and Management of Suicide (CAMS) framework is a clinical philosophy of care (https://cams-care.com). It is an evidence-based framework used to assess suicidality and inform and guide the treatment and care planning process for people who are suicidal and are at risk. It is a flexible approach that can be used across theoretical orientations and disciplines and has been used across treatment settings and treatment modalities. A collaborative and person-centered focus is fundamental to CAMS with the aim being to have the consumer be the co-author of their treatment plan.

Delivery of CAMS typically involves three specific phases: an initial session of assessment and treatment planning, interim sessions that focus on monitoring and understanding current suicide risk and treatment of suicidal drivers and a final session that looks at outcomes and next steps. Completion of the Suicide Status Form is a key part of delivering CAMS that functions as a clinical roadmap for assessment, treatment planning, tracking of ongoing risk, and, ultimately, clinical outcomes. Safety planning (called a Stabilisation Plan) is part of the first CAMS session.

CAMS can be delivered face to face or virtually and is usually delivered one-to-one. CAMS is delivered by a mental health clinician. Sessions are delivered over a timeframe negotiated between therapist and consumer. Weekly or fortnightly appointments are not unusual because of the presence of suicide risk. Sessions typically are delivered over 45-60 minutes and duration of treatment is determined by resolution of suicidality (three consecutive sessions where consumer rates 1 or 2 on the 'Rate Overall Risk of Suicide' question, reports 'yes' on the 'Managed Thoughts/Feelings in the past week' and reports 'no' on 'Suicidal behaviour in the past week' items within the Suicide Status Form Core Assessment). This means the minimum number of sessions to reach resolution is four, while the maximum number of sessions that may be offered is unlimited. The modal number of sessions offered in RCTs is 6-8.

For this study, as informed by other inpatient CAMS studies, we propose having CAMS delivered twice weekly face to face and one-on-one during the inpatient stay (as per Ellis, 2017). The key components to deliver (as suggested by Hershey, 2016) during short term inpatient settings is development of a stabilization (safety) plan, discussions about access to lethal means of suicide and preliminary identification of issues in need of treatment (i.e. suicidal drivers) including early work on these, including planning for addressing drivers in post-hospital aftercare. Sessions will take up to an hour and may be delivered in components if required.

For this study, CAMS will be delivered by clinical psychologists or clinical psychologists in training who have completed CAMS training. CAMS training comprises reading the manual (Managing Suicidal Risk by Prof David Jobes) and completing the online education modules. The 265 page manual provides an overview of the development of CAMS and an overview and guided orientation to each of the core components of CAMS, including the Suicide Status Form, coauthoring a suicide-specific treatment plan, tracking suicide risk assessments and treatment plan updates and discharge planning. The book provides a summary of the principles behind each component, the research relevant to each component, a description of how the activity should be completed and a case study description of how the activity was used in practice. The online modules take approximately 8 hours to complete and combine didactic teaching and skills demonstration through role plays. They cover the same content as the manual but are focused on the key messages and demonstrating the activities in practice. Clinicians complete a knowledge test at the end of the course. The manual and the online modules cover all components needed to deliver CAMS including engaging people with suicide prevention-focused treatment, orientation and use of the CAMS forms, treatment strategies, therapy closure and documentation. Clinicians will complete the training in a self-directed manner prior to consumer recruitment commencing and module and test completion will be reviewed to ensure all components have been completed.

After the clinician participants have completed the training, the research team will meet with the clinician participants as a group to discuss and identify if there are any other specific components of the proposed intervention that need to be adapted to be able to be delivered in this study setting.

Clinicians will attend monthly group supervision virtually with a CAMS-certified clinician during the period consumer recruitment is live. A weekly drop-in session with a local senior clinical psychologist experienced with CAMS will also be available to clinician participants during the period consumer recruitment is open. The purpose of these forums is to discuss practice-related issues in delivering CAMS and receive advice about how to proceed. Attendance logs will be kept for both forums.

Review of completion of CAMS forms as stored within the consumer's medical record will also occur to capture fidelity to treatment.

A focus group with clinicians will be conducted at the completion of consumer recruitment. The focus group will focus on clinicians' experience of the delivering CAMS, barriers and facilitators and learnings from the trial about the fit of the intervention within the inpatient setting. The focus group will be facilitated by a clinical psychologist with experience in running focus groups and a good understanding of CAMS, supported by an experienced research officer familiar with service delivery in inpatient settings and qualitative research. All clinician participants who chose to be involved will be able to be involved. Focus groups will be run with up to 8 people.

Intervention code [1]

Treatment: Other

Intervention code [2]

Behaviour

Intervention code [3]

Prevention

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Feasibility as indicated by 80% of consumer participants receiving 1 session of CAMS during hospital stay

Timepoint [1]

Hospital discharge (on average, ~2 weeks after admission/recruitment)

Primary outcome [2]

Consumer acceptability as indicated by <20% of consumer participants disengaging (choosing not to continue) from CAMS while in hospital.

Timepoint [2]

Hospital discharge (on average, ~2 weeks after admission/recruitment)

Secondary outcome [1]

Feasibility indicated by 100% of clinician participants completing CAMS training

Timepoint [1]

Four months after invitation to complete training

Secondary outcome [2]

Feasibility indicated by consumer recruitment target being reached (3 consumer participants per clinician within 3 months)

Timepoint [2]

Four months after consumer recruitment phase commences

Secondary outcome [3]

Feasibility indicated by refusal rate to take part in study being less than 50%

Timepoint [3]

Four months after consumer recruitment phase commences

Secondary outcome [4]

Acceptability indicated by positive feedback about intervention from consumer participants

Timepoint [4]

One week after discharge from hospital.

Secondary outcome [5]

Consumer positive attitudes towards the intervention- re: acceptability

Timepoint [5]

For consumer participants, at discharge (on average, ~2 weeks after admission/recruitment).

Secondary outcome [6]

Acceptability indicated by number of adverse events (<1) associated with intervention

Timepoint [6]

End of the trial (4 months after commencement of consumer particpcipant recruitment period)

Secondary outcome [7]

Suicidal ideation

Timepoint [7]

Baseline, discharge (on average, ~2 weeks after admission/recruitment), four weeks post-recruitment

Secondary outcome [8]

Depression

Timepoint [8]

Baseline, discharge (on average, ~2 weeks after admission/recruitment), four weeks post-recruitment

Secondary outcome [9]

Suicidal behaviour

Timepoint [9]

Baseline, discharge (on average, ~2 weeks after admission/recruitment), four weeks post-recruitment

Secondary outcome [10]

Acceptability indicated by consumer satisfaction with treatment

Timepoint [10]

Discharge only (on average, 2 weeks after admission/recruitment)

Secondary outcome [11]

Engagement with community mental health services

Timepoint [11]

Four weeks post-discharge

Secondary outcome [12]

Re-presentations to Emergency Department of psychiatric units for mental health and/or self-harm or suicidal concerns

Timepoint [12]

Four months post-discharge

Secondary outcome [13]

Acceptability indicated by positive feedback about intervention from clinicians

Timepoint [13]

At the end of the trial (at least four months after consumer recruitment commences)

Secondary outcome [14]

Clinician positive attitudes towards treatment- re: acceptability

Timepoint [14]

At the end of the trial (at least four months after consumer recruitment commences)

Secondary outcome [15]

Consumer positive attitudes towards the intervention- re: appropriateness

Timepoint [15]

For consumer participants, at discharge (on average, ~2 weeks after admission/recruitment).

Secondary outcome [16]

Consumer positive attitudes towards the intervention- re: feasibility

Timepoint [16]

For consumer participants, at discharge (on average, ~2 weeks after admission/recruitment).

Secondary outcome [17]

Consumer positive attitudes towards the intervention- re: useability

Timepoint [17]

For consumer participants, at discharge (on average, ~2 weeks after admission/recruitment).

Secondary outcome [18]

Clinician positive attitudes towards treatment- re: acceptability

Timepoint [18]

At the end of the trial (at least four months after consumer recruitment commences)

Secondary outcome [19]

Clinician positive attitudes towards treatment- re: feasibility

Timepoint [19]

At the end of the trial (at least four months after consumer recruitment commences)

Secondary outcome [20]

Clinician positive attitudes towards treatment- re: useability

Timepoint [20]

At the end of the trial (at least four months after consumer recruitment commences)

Eligibility

Key inclusion criteria

Clinician participants: Employed as a psychologist on an acute mental health inpatient unit within the Hunter New England Local Health District (NSW, Australia).

Consumer participants:
- Adults (18+ years) admitted to an acute mental health inpatient unit within the Hunter New England Local Health District (NSW, Australia) that has a psychologist trained in CAMS.
- Report suicidality at admission or a recent suicide attempt (within a month before admission)
- Able to provide informed consent about their treatment (assessed by treating team)

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Clinician participants:
Employed on a temporary contract that will cease during the consumer recruitment period.

Consumer participants:
Not able to provide informed consent about their treatment
Cognitive impairment (e.g. major memory problems, unable to follow straightforward instructions) to the degree that it would significantly affect capacity to engage in psychological treatment, as assessed by the treating team
Requires interpreter support to engage in psychological treatment
Care plan contraindicates CAMS

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)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

9/08/2024

Actual

Date of last participant enrolment

Anticipated

30/11/2024

Actual

Date of last data collection

Anticipated

31/03/2025

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Calvary Mater Newcastle - Waratah

Recruitment hospital [2]

Tamworth Rural Referral Hospital - Tamworth

Recruitment postcode(s) [1]

2298 - Waratah

Recruitment postcode(s) [2]

2340 - Tamworth

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Hunter New England Mental Health Service

Address [1]

Country [1]

Australia

Primary sponsor type

Government body

Name

Hunter New England Local Health District

Address

Edith St, Waratah

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

Lookout Road, John Hunter Hospital, Rankin Park, 2287

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/06/2023

Approval date [1]

25/07/2023

Ethics approval number [1]

Summary

Brief summary

Collaborative Assessment and Management of Suicide (CAMS) is a psychological therapy that outperforms other active interventions in reducing suicidal ideation, improving distress and hopelessness, reducing treatment disengagement and higher consumer satisfaction. Only two trials have investigated CAMS delivered within inpatient settings and neither have been conducted in Australia. 

Within this context, the aim of this study is to investigate whether it is feasible to deliver CAMS in the Australian inpatient setting, whether the treatment is acceptable to consumers and clinicians and ensure outcomes are in line with what would be expected. CAMS may be a good fit for Australian psychiatric inpatient settings, but the relevance and feasibility of this approach is yet to be established here.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Katie McGill

Address

Hunter New England Mental Health Service, Edith St, Waratah, NSW, 2298

Country

Australia

Phone

+61 0418776029

Fax

[email protected]

Contact person for public queries

Name

Katie McGill

Address

Hunter New England Mental Health Service, Edith St, Waratah, NSW, 2298

Country

Australia

Phone

+61 0418776029

Fax

[email protected]

Contact person for scientific queries

Name

Katie McGill

Address

Hunter New England Mental Health Service, Edith St, Waratah, NSW, 2298

Country

Australia

Phone

+61 0418776029

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Was not included in ethics submission/approval

What supporting documents are/will be available?

Doc. No.	Type	Email
21471	Study protocol	[email protected]
21472	Analytic code	[email protected]
21473	Statistical analysis plan	[email protected]
21474	Informed consent form	[email protected]
21475	Clinical study report	[email protected]
21476	Ethical approval	[email protected]
21477	Data dictionary	[email protected]

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.

Trial Review

Documents added manually

Documents added automatically