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Trial registered on ANZCTR


Registration number
ACTRN12622000168752
Ethics application status
Approved
Date submitted
16/12/2021
Date registered
1/02/2022
Date last updated
1/06/2023
Date data sharing statement initially provided
1/02/2022
Date results information initially provided
1/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
LISTEN - Low Intensity mental health Support via a Telehealth Enabled Network for adults with diabetes and CVD: Effectiveness and scalability
Scientific title
LISTEN - Low Intensity mental health Support via a Telehealth Enabled Network for adults with diabetes and CVD: Effectiveness and scalability
Secondary ID [1] 306047 0
TTRARP1089
Universal Trial Number (UTN)
Trial acronym
LISTEN (Low Intensity mental health Support via a Telehealth Enabled Network trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 324689 0
Mental health 324690 0
Cardiovascular disease 324691 0
Condition category
Condition code
Metabolic and Endocrine 322134 322134 0 0
Diabetes
Cardiovascular 322136 322136 0 0
Other cardiovascular diseases
Mental Health 322137 322137 0 0
Depression
Mental Health 322138 322138 0 0
Anxiety
Mental Health 322139 322139 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 322447 0
Behaviour
Comparator / control treatment
The control group will receive usual care provided to registrants of the National Diabetes Services Scheme (NDSS) including weblinks to NDSS factsheets about mental health (freely available on the NDSS website: https://www.ndss.com.au/living-with-diabetes/health-management/mental-health/), as well as links to external mental health support (e.g. Beyond blue) and if needed, a referral to their GP to discuss the best support for their emotional wellbeing.
Control group
Active

Outcomes
Primary outcome [1] 329901 0
Diabetes distress, assessed using the Problem Areas in Diabetes (PAID) Scale
Timepoint [1] 329901 0
Diabetes distress will be assessed at baseline, 8-weeks and 6-months follow-up.
The primary endpoint is 6-month follow-up (post-randomisation and allocation to the intervention or control arm).
Secondary outcome [1] 404202 0
Emotional wellbeing assessed using the World Health Organisation- Five Well-Being Index (WHO-5)
Timepoint [1] 404202 0
Emotional wellbeing will be assessed at baseline, 8-weeks and 6-months follow-up.
Secondary outcome [2] 404336 0
Perceived ability to cope effectively with life challenges assessed using the Coping Self-Efficacy Scale (CSES)
Timepoint [2] 404336 0
Coping will be assessed at baseline, 8-weeks and 6-months follow-up.
Secondary outcome [3] 404337 0
Immediate impact on diabetes distress assessed using the Problem Areas in Diabetes (PAID) Scale
Timepoint [3] 404337 0
8-week follow-up (post-randomisation and allocation to the intervention or control arm)
Secondary outcome [4] 405142 0
Depression will be assessed using the Kessler Psychological Distress Scale (K10)
Timepoint [4] 405142 0
Depression will be assessed at baseline, 8-weeks and 6-months follow-up.
Secondary outcome [5] 405143 0
Anxiety will be assessed using the Kessler Psychological Distress Scale (K10)
Timepoint [5] 405143 0
Anxiety will be assessed at baseline, 8-weeks and 6-months follow-up.
Secondary outcome [6] 405146 0
Intervention feasibility.
Study-specific intervention use items (e.g. the number of participants completing LISTEN, intervention/session duration and dose) will be assessed by an audit of the study database.
Timepoint [6] 405146 0
8 weeks post-randomisation and allocation to the intervention or control arm.
Secondary outcome [7] 405147 0
Economic evaluation.
Quality-adjusted-life-years (QALYs) assessed using the four-dimension Assessment of Quality of Life (AQoL4D) instrument,
Timepoint [7] 405147 0
Baseline, 8 weeks, and 6-month follow-up
Secondary outcome [8] 405148 0
Economic evaluation.
Resource use and productivity impacts questionnaire (study specific instrument) to assess healthcare resources used and lost productivity
Timepoint [8] 405148 0
8 weeks and 6-month follow-up (post-randomisation and allocation to the intervention or control arm).
Secondary outcome [9] 405149 0
A process evaluation outcome is the extent to which a participant's goals are met using the Goal Attainment Scale
Timepoint [9] 405149 0
8-weeks and 6-month follow-up (post-randomisation and allocation to the intervention or control arm).
Secondary outcome [10] 405150 0
Intervention acceptability.
Participant acceptability with the LISTEN intervention will be assessed using a study specific online questionnaire at 8-week follow up and individual telephone (or videoconference) audio recorded interview with a member of the research team post-intervention.
Timepoint [10] 405150 0
8-week follow-up (post-randomisation and allocation to the intervention or control arm)

Eligibility
Key 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

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

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation sequence will be generated via central randomisation by computer and the allocation fully concealed from the investigator, researcher team and participants. Upon randomisation, participants will be notified of their group allocation, via e-mail, by a Deakin researcher independent of the study investigator team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation to either the intervention or control arm will be conducted using random permuted blocks (4, 6 or 8), stratified by diabetes type, gender and age (less than 60 years; greater than or equal to 60 years old).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome will be measured using a validated scale: Diabetes distress, measured using the Problem Area in Diabetes (PAID) scale. Analyses be conducted on an intention-to-treat (ITT) basis. Repeated measures analysis of variance (ANOVA), or a mixed model analysis (residual maximum likelihood (REML) method) will be used to analyse the primary outcome. The null hypothesis, that there is no difference in the primary outcome between the control and intervention groups will be assessed using p-values for the fixed-effects for the associated covariates in each model, with a p-value <0.05 deemed statistically significant. In the event that some participants have missing assessments at 6-months, the analysis of variance will be replaced by a mixed model analysis using the REML method. A per protocol set (PPS) will include only those participants who adhere to all aspects of the study protocol and complete a minimum of one LISTEN session (intervention) or access the web-based resource (control) will be used for a sensitivity analysis of the primary endpoint. Secondary outcomes, including psychological distress (K10), general emotional wellbeing (WHO-5) and coping self-efficacy (CSES) will be analysed as per the primary outcome.
Qualitative data from semi-structured interviews will be de-identified, transcribed verbatim using a professional transcriber and imported into NVivo. Thematic analyses will be used to explore and identify key themes about participant’s experiences of the LISTEN intervention and barriers to, and facilitators of, adoption and implementation.

To assess, from a health sector and broader societal perspective, costs and value for money of LISTEN compared to usual care (control). A detailed costing will be undertaken using financial data and micro-costing methods. Within trial, data will be collected including the Four-Dimensional Assessment of Quality-of-Life Instrument (AQoL4D), to generate quality-adjusted-life-years (QALYs). Scale-up and implementation costs as well as longer term cost effectiveness (e.g. over 5 year time horizon) will be estimated based on population-wide modelling techniques. The AQoL4D will enable cost-utility analyses whereby costs/QALYs gained will be estimated for LISTEN compared to usual care. Standardised economic evaluation techniques will be used, including incremental analysis of mean differences using standardised statistical techniques such as generalised linear models. Bootstrapping will be used to determine confidence intervals for incremental cost effectiveness ratio along with a net monetary analysis to determine the cost-effectiveness of the intervention for various ‘value for money’ threshold criteria.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
15/08/2022
Actual
22/08/2022
Date of last participant enrolment
Anticipated
30/04/2023
Actual
5/05/2023
Date of last data collection
Anticipated
31/10/2023
Actual
Sample size
Target
454
Accrual to date
Final
429
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310382 0
Government body
Name [1] 310382 0
The Australian Government Department of Health
Country [1] 310382 0
Australia
Funding source category [2] 310385 0
Other
Name [2] 310385 0
Diabetes Australia
Country [2] 310385 0
Australia
Funding source category [3] 310386 0
Other
Name [3] 310386 0
Diabetes Victoria
Country [3] 310386 0
Australia
Primary sponsor type
University
Name
The Australian Centre for Behavioural Research in Diabetes, Deakin University
Address
1 Gheringhap Street Geelong Vic 3220
Country
Australia
Secondary sponsor category [1] 311531 0
None
Name [1] 311531 0
Address [1] 311531 0
Country [1] 311531 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310034 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 310034 0
Deakin University
Melbourne Burwood Campus
221 Burwood Highway, Burwood, VIC 3125, Australia
Ethics committee country [1] 310034 0
Australia
Date submitted for ethics approval [1] 310034 0
17/11/2021
Approval date [1] 310034 0
21/12/2021
Ethics approval number [1] 310034 0
2021-412

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116262 0
Dr Edith Holloway
Address 116262 0
The Australian Centre for Behavioural Research in Diabetes (a partnership between Diabetes Victoria and Deakin University), 570 Elizabeth Street, Melbourne VIC 3000
Country 116262 0
Australia
Phone 116262 0
+61392446382
Fax 116262 0
Email 116262 0
eholloway@acbrd.org.au
Contact person for public queries
Name 116263 0
Dr Edith Holloway
Address 116263 0
The Australian Centre for Behavioural Research in Diabetes (a partnership between Diabetes Victoria and Deakin University), 570 Elizabeth Street, Melbourne VIC 3000
Country 116263 0
Australia
Phone 116263 0
+61392446382
Fax 116263 0
Email 116263 0
eholloway@acbrd.org.au
Contact person for scientific queries
Name 116264 0
Dr Edith Holloway
Address 116264 0
The Australian Centre for Behavioural Research in Diabetes (a partnership between Diabetes Victoria and Deakin University), 570 Elizabeth Street, Melbourne VIC 3000
Country 116264 0
Australia
Phone 116264 0
+61392446382
Fax 116264 0
Email 116264 0
eholloway@acbrd.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not intend to use the data collected from this study for any other purpose than that described in this trial application, as per the Participant Plain Language Statement and Consent Form.


What supporting documents are/will be available?




Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLow-Intensity mental health Support via a Telehealth Enabled Network for adults with diabetes (LISTEN): protocol for a hybrid type 1 effectiveness implementation trial.2023https://dx.doi.org/10.1186/s13063-023-07338-5
N.B. These documents automatically identified may not have been verified by the study sponsor.