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A clinical trial about the effectiveness of a supported employment linkage intervention for people with schizophrenia admitted to an adult mental health unit who want to work.

A single blind randomised controlled clinical trial comparing a supported employment linkage intervention to treatment as usual on work and clinical outcomes in chronic schizophrenia.

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001638426
Acronym
SET
Enrollment
49
Registered
2016-11-25
Start date
2017-06-19
Completion date
2020-03-25
Last updated
2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Aim: This is a single blind randomised controlled clinical trial comparing a new therapeutic intervention in addition to Treatment As Usual (TAU) with TAU for patients with schizophrenia at the Sir Charles Gairdner Hospital Mental Health Unit (SCGH MHU) who want to work. The new therapeutic intervention is called the Supported Employment Linkage Intervention (SEL).The primary hypothesis tested is the addition of SEL to TAU will improve engagement, by patient choice, with a local employment agency called EDGE and procurement of a competitive job. EDGE has good fidelity to the Individual Placement and Support Approach to Supported Employment. We will also see if psychiatric symptoms, cognition, hope and social inclusion will be improved with the addition of SEL to TAU significantly more than with TAU alone. Method: The outcomes measured will be change in: The Engagement with Edge Questionnaire (EEQ), Job Acquisition Questionnaire (JAQ), Brief Psychiatric Rating Scale (BPRS), Trail Making Test A+B, Digit Span Test (Wechsler Adult Intelligence Scale – Revised),, Adult Hope Scale, and the Activity and Participation Questionnaire (APQ-6). Measures will be collected at baseline by the research mental health nurse clinicians and 6 months and 12 months post recruitment by a blinded research officer unfamiliar with the site. Expected Outcomes: We expect successful engagement with an employment agency called Edge, as measured by the Engagement with Edge Questionnaire (EEQ), to equal a 6 month block of registration with Edge during the 12 month period post recruitment and to be significantly better with SEL + TAU compared to TAU over 12 months post recruitment. We expect yes to a competitive job, as measured by the Job Acquisition Questionnaire (JAQ), to be significantly greater with SEL + TAU compared to TAU at 4 varying time points over 2 years post recruitment. Hope, and social inclusion are anticipated to be significantly improved with SEL + TAU compared to TAU as measured the Adult Hope Scale and the Activity and Participation Questionnaire (APQ-6) respectively at 6 and 12, months post recruitment.

Interventions

There will be two study arms in this clinical trial. Arm 1: Supported Employment Linkage Intervention (SEL) and Treatment As Usual (TAU). Arm 2: Treatment As Usual (TAU). SEL involves mental health nurse clinicians, with outreach capacity, working on the Sir Charles Gairdner Hospital Mental Health Unit (SCGH MHU), who will deliver the intervention. The intervention starts during the inpatient admission., The patient is linked to an employment agency, called Edge, which is for people with men

There will be two study arms in this clinical trial. Arm 1: Supported Employment Linkage Intervention (SEL) and Treatment As Usual (TAU). Arm 2: Treatment As Usual (TAU). SEL involves mental health nurse clinicians, with outreach capacity, working on the Sir Charles Gairdner Hospital Mental Health Unit (SCGH MHU), who will deliver the intervention. The intervention starts during the inpatient admission., The patient is linked to an employment agency, called Edge, which is for people with mental and physical disabilities . Edge has good fidelity to the Individual Placement and Support (IPS) model of supported employment as measured by the IPS fidelity scale. The mental health nurse clinician forms a therapeutic relationship with the patient as soon as they complete their comprehensive medical assessment by their treating team on the SCGH MHU and it is deemed during this assessment the patient has schizophrenia and wants to work in competitive employment. The patient is given a blank Treating Doctor’s Report (TDR) and a Verification of Medical Condition(s) form (VMC) in an Edge Information Pack (EIP) by the nurse to be filled out by the patient’s general practitioner validating capability for at least 8 hours competitive work per week. The TDR and VMC are required to state the patient’s diagnosis, symptoms and an overview of their current medical conditions. The nurse supports and empowers the patient to find and attend a general practitioner to fill out the TDR and VMC while still on the SCGH MHU wherever possible. However this step can occur after discharge. If the patient’s team are supporting a disability pension application this process and the required forms are completed by the treating Team first. The nurse empowers the patient to make and attend an appointment with Edge during the admission or after discharge. The wait list is 1 week at the most. At the initial and subsequent Edge interviews a family member is welcome to attend. During this initial Edge interview the reality of the patient’s career aspirations is determined and their medical condition disclosed. Regional work in the mining industry is explained as a non-option through Edge. The patient plus or minus a family member and Edge worker, request and keep an appointment with Centrelink, the pension agency, for a job capacity assessment (JCA) and an Employment Services Assessment (ESAT) by a job capacity assessor. This appointment could occur whilst an inpatient on the SCGH MHU but may occur after discharge. The patient brings their completed VMC and TDR to this appointment. Based on a 15-30 minute interview and the VMC and TDR the assessor determines the genuineness of the disability and the capacity for at least 8 hours per week work whilst on the disability pension or 15 hours per week if not on the disability pension. The patient has to specify that they want Edge for help with job searching and ongoing job support. Centrelink then make a registration appointment with Edge via an on-line diary for the patient plus or minus a family member. Once Edge receives the Centrelink job capacity assessor’s on-line report and appointment they contact the patient to come in for this registration appointment. This usually takes 1-2 weeks. The patient can go into Edge to see how this is progressing if they are anxious. At the registration appointment with Edge the work capacity is checked as correct. The work goals and aspirations are again determined as reality based and an employment specialist is allocated. Financial counselling, if required, is offered by a financial counsellor. After discharge from the SCGH MHU the designated mental health nurse contacts the patient weekly by telephone to empower them to be able to work through the steps required to become embedded in the employment agency, Edge, and trust and work with its support. The nurse provides weekly telephone contact for up to 6 months from the date of recruitment and the frequency is individually tailored. The ending of this contact is patient determined in collaboration with the nurse . Edge will provide support with job search to find an employer who wants to make a place for a sensitive stigmatised individual with schizophrenia in their workplace as well as ongoing job support. Edge requires mandatory 2 weekly appointments with the Edge employment specialist and the patient. Additional support is individually tailored by Edge. The employment specialist helps with resumes, job finding, interviews, and on and off job support. For patients who don’t attend appointments Edge will provide a telephone call, one letter and a wait of 6 months before deregistering the patient. However, the SCGH MHU nurse still has the capacity to make telephone contact with the patient on a weekly basis for up to 6 months following recruitment at the SCGH MHU. These linkage attempts will stop or restart by patient request. If no open competitive employment is found within 2 years the patient is discharged from Edge. The patient can go through the Edge admission process again at any time. The patient can transfer to another employment agency. The nurse will contact Edge 2 monthly to check on the patient’s progress and provide help with any issues. A successful supported employment linkage intervention is achieving at least a 6 month block of registration with Edge in the 2 year period post recruitment.

Sponsors

North Metropolitan Health Service -Adult Mental Health
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Diagnosis of schizophrenia defined by DSM-V and want to work; not previously received or currently receiving the supported employment linkage intervention; voluntary and involuntary residents of SCGH MHU Tanami ward; plans to reside in Australia for the duration of follow-ups; available for follow-up for 2 years; able to comply with requirements of the protocol; able and willing to understand and provide written informed consent; aged between 18 and 65 years of age.

Exclusion criteria

Highly dependent on medical care; significant communication barrier.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026