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Effectiveness of Low Intensity mental health Support via a Telehealth Enabled Network (LISTEN) for adults with diabetes distress: A parallel group, pragmatic randomised controlled trial

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posted on 2025-05-20, 00:10 authored by Edith E Holloway, Laura Jenkins, Paul A Agius, Sarah Manallack, Roslyn Le Gautier, Cathrine Mihalopoulos, Mary Lou Chatterton, Vincent L Versace, Jennifer Halliday, Virginia Hagger, Shikha Gray, Kim Henshaw, Ben Harrap, Natasha Van Bruggen, Taryn Black, Glen Noonan, Carolyn Hines, Adrienne O’Neil, Timothy C Skinner, Jane Speight, Christel Hendrieckx

OBJECTIVE: To assess the effectiveness of Low Intensity mental health Support via a Telehealth Enabled Network (LISTEN), facilitated by diabetes health professionals, for reducing diabetes distress among adults with type 1 or type 2 diabetes.

RESEARCH DESIGN AND METHODS: A two-arm, parallel group, pragmatic randomised controlled trial.  Adults with diabetes distress (Problem Areas in Diabetes [PAID-20] score ≥25, or ≥2 on three or more items) were recruited via the National Diabetes Services Scheme (NDSS) and randomised (1:1) via central randomisation by computer to LISTEN (maximum four sessions of problem-solving therapy) or usual care (web-based resources about diabetes and emotional health). Participants completed self-report online surveys at baseline, 8 and 26 weeks. The primary outcome was the change in diabetes distress (PAID-20) from baseline to 26 weeks. Secondary outcomes included psychological distress (K-10), general emotional well-being (WHO-5) and coping-self-efficacy (CSE) at 8 and 26 weeks. Data were analysed using intention-to-treat principles.

RESULTS: Participants (n=429, 59% women, 40% men, 1% non-binary; median age 54 [IQR 42.0-63.5]; 37% type 1 diabetes, 63% type 2 diabetes) were enrolled and randomised to the intervention (n=216) or control group (n=213). Over 26 weeks, there was a greater reduction in diabetes distress among the LISTEN group versus control (mean difference -7.2 [95% CI -11.6, -2.8]; p<0.001; Cohen's f2=0.03); and greater improvements in general emotional well-being and coping self-efficacy. No adverse events were reported.

CONCLUSIONS: LISTEN is an effective, low-intensity program, addressing the unmet needs of adults with type 1 and type 2 diabetes experiencing mild-to-moderate diabetes distress.

Funding

This project received funding from the Australian Government’s Medical Research Future Fund (MRFF), as part of the Targeted Translation Research Accelerator (TTRA) program, delivered by MTPConnect (grant number: TTRARP1089). The project also received financial and in-kind contributions from partner organisations. Diabetes Australia provided financial and in-kind contributions that enabled delivery of the LISTEN program (e.g. training, time, and infrastructure for health professionals). We also acknowledge financial and in-kind contributions from Diabetes Victoria, and in-kind contributions from the Australian Diabetes Educators Association. CH and JS were supported by core funding to the Australian Centre for Behavioural Research in Diabetes provided by the collaboration between Diabetes Victoria and Deakin University. During protocol development, JAH was supported by an unrestricted educational grant provided to the Australian Centre for Behavioural Research in Diabetes (ACBRD) by Diabetes Australia. AO is supported by a National Health & Medical Research Council Emerging Leader 2 Fellowship (2009295). VLV is supported by the Rural Health Multidisciplinary Training (RHMT) Program (Australian Government, Department of Health and Aged Care).

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