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Care navigation for adults with depression or anxiety: A pilot trial

Acceptability and feasibility of care navigation for adults with depression or anxiety: A mixed methods pilot trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000004763
Enrollment
12
Registered
2022-01-10
Start date
2022-10-28
Completion date
2023-10-20
Last updated
2025-01-06

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

Conditions

None listed

Brief summary

The Care Navigation intervention is a 6-month program of support for adult patients with depression and/or anxiety referred by a GP to the Black Dog Institute (BDI) Psychiatry Services. It aims to assist participants in navigating the mental health system and implementing the treatment plan written by their BDI psychiatrist, and to subsequently improve their mental health outcomes. The primary aim of this pilot trial is to determine the feasibility and acceptability of the Care Navigation intervention for adults with depression and/or anxiety and to identify necessary improvements. Acceptability will be assessed by participants’ ratings of satisfaction and by interviews with participants, Patient Care Navigators and BDI clinical staff. A further aim of this pilot trial is to conduct a preliminary examination of the efficacy of the Care Navigation intervention in improving clinical outcomes, including symptoms of depression (PHQ-9) and anxiety (GAD-7), functional impairment, mental health self-efficacy and health care utilisation. Changes in these outcomes from pre-intervention will be examined within the Care Navigation group at both mid-intervention (3 months) and post-intervention (6 months).

Interventions

The Care Navigation intervention is a 6-month program of support for adult patients with depression and/or anxiety referred by a GP for an assessment by a psychiatrist at the Black Dog Institute (BDI) Psychiatry Services. It aims to assist participants in navigating the mental health system and implementing the treatment plan written by their BDI psychiatrist and to subsequently improve mental health outcomes. It will be offered in addition to care as usual by participants’ referring GPs, and any other health professionals involved in their care (eg psychologist). The Care Navigation intervention includes three main components: 1) Participants will be provided with a copy (both digital and hardcopy) of the report and treatment plan written by their BDI psychiatrist, and will be offered a 30-minute feedback session with their BDI psychiatrist to ensure that they understand their diagnoses and treatment plan and have the opportunity to ask questions and express their preferences. As with care as usual, the report will also be sent to their referring GP. Also in line with care as usual, the treatment plan may include recommendations for medication, psychological therapy and/or self-management strategies, and may also include referral to other health professionals in the BDI Clinical Services, such as psychologists and exercise physiologists, and/or to online interventions or external services. 2) Scheduled follow-up calls from a BDI Patient Care Navigator to assist the participant with navigation of the mental health system, to identify any barriers to the implementation of their BDI treatment plan, and to offer assistance with accessing recommended health professionals or services. Each participant will be allocated one BDI Patient Care Navigator, who will be able to refer to that participant’s BDI psychiatrist report and treatment plan. The follow-up calls will be approximately fortnightly for the first three months and then monthly for the following three months, and will be of approximately 10 minutes duration. BDI Patient Care Navigators will make session notes for each of their follow-up calls in MediRecords in the BDI Clinical Services (ie, the clinic’s standard clinical management software), which will be able to be accessed by BDI clinical staff, including the participant’s BDI psychiatrist. 3) A final review by their BDI psychiatrist at six months, with a final report and discharge plan being provided to both the participant and referring GP. In addition, in line with care as usual provided by the BDI Psychiatry Services, participants may also have earlier review sessions by their BDI psychiatrist, according to their clinical need. It is anticipated that most participants would take part in two to three psychiatric review sessions over the six-month period. All participants will be offered the final review by their BDI psychiatrist at six months. Review sessions with a BDI psychiatrist will be of approximately 45 minutes duration. The Patient Care Navigators in the pilot trial will be five staff (non-clinicians) currently employed in the BDI Clinical Services to provide administrative and advocacy support for patients. They were consulted in the co-design process of the Care Navigation intervention, and will be supported by training prior to the trial, a manual outlining the procedures of the intervention and example scripts, weekly supervision by a clinical psychologist, and a BDI “Psychologist on Duty” each day. Patient Care Navigators will not be conducting mental health assessments, providing case management or psychological therapy or writing reports for referring GPs or other health professionals. The Care Navigation intervention will be manualized and primarily delivered via by telehealth. Psychiatrist consultations will be delivered as per care as usual for the BDI Clinical Services. That is, they will always be offered via teleconference, however, pending pandemic-related restrictions, they may also be available face-to-face. Patient Care Navigator follow-up calls will be by telephone.

Sponsors

University of New South Wales
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

1) Primary issue is a mood or anxiety disorder 2) GP referral to the BDI Psychiatry Services for an assessment by a BDI psychiatrist 3) Minimum score of 10 on the PHQ-9 (indicating moderate or more severe symptoms of depression) and/or minimum score of 10 on the GAD-7 (indicating moderate or more severe symptoms of anxiety) 4) Live in NSW 5) Aged 18 years or over 6) Able to speak, read and write in English 7) Have provided consent to be contacted regarding research on the BDI Clinical Services registration form

Exclusion criteria

1) Psychiatrist referral 2) Currently engaged with a psychiatrist external to BDI 3) Medico-legal case 4) Bipolar I 5) Current symptoms of psychosis 6) History of psychosis 7) Dementia 8) Cognitive impairment 9) Substance use disorder or treatment by alcohol and other drug services required 10) Current plan or intent to attempt suicide 11) Inpatient treatment required 12) Engagement with community mental health services required 13) Pregnant

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026