Skip to content

LISTEN - Low Intensity mental health Support via a Telehealth Enabled Network for adults with diabetes and CVD: Effectiveness and scalability

LISTEN - Low Intensity mental health Support via a Telehealth Enabled Network for adults with diabetes and CVD: Effectiveness and scalability

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000168752
Acronym
LISTEN (Low Intensity mental health Support via a Telehealth Enabled Network trial)
Enrollment
429
Registered
2022-02-01
Start date
2022-08-22
Completion date
2023-05-05
Last updated
2024-08-19

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

Conditions

None listed

Brief summary

Around half of all people with diabetes and cardiovascular disease (CVD) experience mental health problems. This has devastating consequences for clinical outcomes, quality of life, as well as for the healthcare system. LISTEN (Low Intensity mental health Support via Telehealth Enabled Network) provides a telehealth solution for integrated low-intensity mental health and diabetes and CVD self-management support. LISTEN will be delivered by allied health professionals servicing the National Diabetes Services Scheme (NDSS) Helpline, including diabetes educators, nurses, and dieticians, who have undertaken our brief, evidence-based training program. Adults with diabetes and CVD will have access to up to four (45-60 minute) LISTEN sessions. In this trial we will evaluate if LISTEN is a feasible, effective and cost-effective solution for improving mental health outcomes in adults with diabetes and CVD. This important research will generate robust evidence needed by our partners (Diabetes Australia/NDSS and Diabetes Victoria) to inform clinical and commercial translation of LISTEN into a sustainable service, designed to have immediate and lasting positive impact on the mental health of people with diabetes and CVD.

Interventions

The LISTEN intervention: The intervention group will receive up to four x 45-60 minute LISTEN sessions, once per week (for a maximum of four weeks). The sessions are delivered via telehealth (telephone or videoconference) by a trained diabetes allied health professional (AHPs; diabetes educators, nurses, and dietitians) who have a minimum of 12 months experience working in a diabetes setting. The number of sessions that participants receive will be mutually agreed upon by the participant and th

The LISTEN intervention: The intervention group will receive up to four x 45-60 minute LISTEN sessions, once per week (for a maximum of four weeks). The sessions are delivered via telehealth (telephone or videoconference) by a trained diabetes allied health professional (AHPs; diabetes educators, nurses, and dietitians) who have a minimum of 12 months experience working in a diabetes setting. The number of sessions that participants receive will be mutually agreed upon by the participant and the AHP and will be guided by the ease at which participants are able to develop the problem solving skills and the suitability of the intervention to meet participants needs. At its core, the LISTEN intervention provides individuals with diabetes (and cardiovascular disease) with practical skills in problem-solving using brief Problem-Solving Therapy (PST). Adapted for an Australian population of adults with diabetes, this low-intensity version is suitable for delivery by non-specialist mental health professionals and has the advantage of fewer and shorter sessions in order to meet the pressing time and resource issues in busy clinical settings. Participants receive guidance and support to identify problems that may be contributing to their mental health issues, including distress and anxiety about living with diabetes. The participant is guided through seven steps: (1) defining the problem; (2) setting an achievable goal; (3) brainstorming solutions; (4) assessing pros and cons of solutions; (5) choosing the preferred solution; (6) creating an action plan; (7) evaluating outcomes. Strategies for working through problems that cannot be ‘solved’ will also be addressed. Participants will receive information and worksheets that will help support them between sessions and plan meaningful and enjoyable activities during the week. The worksheets have been adapted from the 'Problem-Solving Treatment Manual for Primary Care (PST-PC): A treatment Manual for Depression' (Hegel & Arean, 2011) and developed specifically for this context. In addition, AHPs will encourage support-seeking behaviours. They will discuss how and when to seek support from mental health services, and how address their barriers for seeking support from a general practitioner or mental health professional. The LISTEN Training: Between 4 and 10 diabetes allied health professionals will be invited to participate in the training. The LISTEN training consists of: (1) participation in four-day online workshops and (2) delivery under supervision. The four-day workshops are derived from an established training program which has demonstrated high-level performance results among trainees (i.e. nurses, social workers, and psychologists). Adapted from an established PST training program, the workshops comprise learning modules that both explain the theory of PST and provid practical skills for facilitating LISTEN sessions, including opportunities to role play a session. Training resources are provided (i.e. session narratives, worksheets, checklists, client resources, and the treatment manual adapted for diabetes AHPs in Australia). The worksheets have been adapted from the 'Problem-Solving Treatment Manual for Primary Care (PST-PC): A treatment Manual for Depression' (Hegel & Arean, 2011) and developed specifically for this context. The workshops and training also focus on strategies to strengthen AHPs skills in empathic listening and encouraging support-seeking behaviour. AHPs are guided on how to address barriers that people with diabetes may experience in seeking support from a general practitioner (GP) or mental health professional. AHPs are familiarised with the mental health referral pathways and processes. The workshops will be delivered by two experienced research fellows with knowledge and expertise in: a) psychological therapies, including PST; b) training health professionals in mental health and emotional support strategies; c) providing supervision; and d) the psychosocial aspects of diabetes. Workshops will be conducted online (via Zoom). The training is scheduled to be completed at least two months in advance of commencing the RCT. Following completion of the workshops, AHPs are allocated a minimum of two and a maximum of four training cases. Training cases are adults with diabetes who meet the inclusion criteria for the RCT and consent to be a training case. LISTEN will be delivered via telehealth (phone or videoconference) and participants are offered <4 sessions of 45- to 60-min duration. With participants’ consent, all training sessions will be audio-recorded. The recorded sessions will be reviewed by the research psychologist and a second member of the research team using the PST-Adherence and Competence Scale (PST-PAC). The PST-PAC examines fidelity to technical skills, adherence to the problem-solving steps, process tasks, communication and interpersonal effectiveness, and global competence based on the complexity of the client presentation. Fidelity is rated from 0 (not completed) to 5 (well above standard), and detailed feedback and supervision for the AHPs will be provided on their ratings via videoconference (45- to 60-min duration). To be deemed competent to deliver LISTEN, the AHP will be required to have completed a minimum of two training cases and achieved an overall score of at least 3 (satisfactory) on the PST-PAC for three consecutively rated sessions to be deemed competent in the delivery of LISTEN and progress to delivery for the RCT. The training cases will be completed prior to commencing the RCT. During the RCT, AHPs will have access to individual monthly supervision/support sessions and ad hoc group supervision sessions, facilitated by the research psychologist. AHPs will audio-record 25% of their sessions with RCT participants and these sessions will be reviewed against the PST-PAC scale to evaluate intervention fidelity.

Sponsors

The Australian Centre for Behavioural Research in Diabetes, Deakin University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

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

Inclusion criteria

- living in Australia - aged 18 years or older - have a diagnosis of diabetes (with or without CVD) - have a total score of 25 or greater on the Problem Areas In Diabetes (PAID) scale, indicating at least mild diabetes distress -have a score less than 6 on the four-item Patient Health Questionnaire

Exclusion criteria

- Have a score greater than or equal to 6 on the four-item Patient Health Questionnaire (PHQ-4) - Participated as a training case during the allied health professional supervised training

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 11, 2026